Tag Archives: Chemical product

Undesirable substances in animal feed

Undesirable substances in animal feed

Outline of the Community (European Union) legislation about Undesirable substances in animal feed

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Undesirable substances in animal feed

Document or Iniciative

Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed [See amending act(s)].

Summary

This Directive sets maximum levels to limit as far as possible the presence of undesirable substances and products in animal feed put into circulation within the European Union (EU).

Undesirable substances

“Undesirable substance” means any substance or product, with the exception of pathogenic agents, which is present in and/or on the product intended for animal feed and which presents a potential danger to animal or human health or to the environment or could adversely affect livestock production. The range of substances covered by the Directive comprises arsenic, lead, mercury, dioxin and certain mustards.

This Directive applies to all products intended for animal feed, including raw materials for feed, additives and complementary feedingstuffs.

List of undesirable substances

The Directive lays down a list of undesirable substances, for which it sets limit values above which their presence in animal feeds is forbidden (see Annex I to the Directive). This list is regularly updated in the light of technical progress.

Investigations

When these maximum levels are exceeded, Member States, in cooperation with the economic operators concerned, must carry out investigations to identify the sources of the substances concerned. They must then inform the Commission of the outcome of these investigations and the measures taken to reduce the level of the substances or eliminate them.

Mixtures

To prevent fraud, the Directive prohibits mixing a product containing undesirable substances with the same product or other products in order to dilute it.

Temporary provisions

There can be no derogations from the Directive. However, where a danger to human or animal health or to the environment becomes apparent, Member States may provisionally take more stringent measures, reducing the maximum level set in the Directive.

Context

Following the dioxin crisis in the late 1990s, the EU made many changes to European undesirable substances in order to improve food security and to better protect human and animal health and the environment.

Directive 2002/32/EC replaces Directive 1999/29/EC as from 1 August 2003.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2002/32/EC

30.5.2002

1.5.2003

OJ L 140, 30.5.2002

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 219/2009

20.4.2009

OJ L 87, 31.3.2009

The successive amendments and corrections to Directive 2002/32/EC have been incorporated into the original text. This consolidated versionis of documentary value only.

Related Acts

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

In the context of the review of food hygiene legislation (“hygiene package”), this Regulation re-organises official controls of food and feed so as to integrate controls at all stages of production and in all sectors. The Regulation defines the European Union’s duties as regards the organisation of these controls, as well as the rules which must be respected by the national authorities responsible for carrying out the official controls, including coercive measures adopted in the event of failure to comply with Community law.

Cosmetic products

Cosmetic products

Outline of the Community (European Union) legislation about Cosmetic products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal welfare

Cosmetic products (from 2013)

Document or Iniciative

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Text with EEA relevance).

Summary

Cosmetic products are substances * or mixtures of substances intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, etc.) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Free movement of these products in the internal market is permitted if they comply with this Regulation.

Market surveillance

A responsible person established in the Community shall be designated for each product placed on the market. This person shall ensure compliance of the products with the rules set out in the Regulation. In particular, they shall ensure compliance with requirements relating to human health, safety and consumer information. They shall maintain a product information file accessible to the public authorities.

In order to ensure product traceability, responsible persons shall identify the distributors to whom they supply the cosmetic product: for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor. The same applies to all other persons involved in the supply chain.

In case of product non-compliance, the responsible person shall take measures to render it compliant, withdraw it from the market or recall it to the manufacturing company in all Member States where the product is available. Where the responsible person does not take all appropriate measures, the competent national authorities may take the necessary corrective measures.

If a product which complies with the requirements of the Regulation presents or could present a serious risk to human health, the competent national authority shall take all necessary provisional measures to withdraw, recall or restrict the availability of the product on the market.

Limitations for certain substances

The Annexes of this Regulation give a list of prohibited substances (Annex II) or restricted substances (Annex III) with respect to use in cosmetic products. Certain colorants (other than those in Annex IV), preservatives (other than those in Annex V) and UV-filters (other than those in Annex VI) are also prohibited.

The Regulation prohibits the use of substances recognised as carcinogenic, mutagenic or toxic for reproduction (classified as CMR), apart from in exceptional cases. It provides for a high level of protection of human health where nanomaterials are used in cosmetic products.

Consumer information

Product labelling contributes to consumer protection. Containers or packaging must bear written information in indelible, easily legible and visible lettering. This information concerns:

  • the name or registered name and the address of the responsible person;
  • the country of origin for imported products;
  • the weight or volume of the content at the time of packaging;
  • a use-by date for products kept in appropriate conditions;
  • precautions for use, including for cosmetics for professional use;
  • the batch number of manufacture or the reference for identifying the cosmetic product;
  • the list of ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing.

The language of the information shall be determined by the Member State where the product is made available to the end user.

Animal testing

Animal testing must be replaced by alternative methods. The Regulation prohibits the performance of animal testing in the European Union for:

  • finished products,
  • ingredients or combinations of ingredients.

The Regulation also prohibits the placing on the European Union market of:

  • products where the final formulation has been the subject of animal testing;
  • products containing ingredients or combinations of ingredients which have been the subject of animal testing.

A derogation from the ban relating to placing products on the market shall be granted until 11 March 2013 in order to test repeated-dose toxicity, the effects of certain substances on reproduction and to study toxicokinetics *.

In exceptional circumstances, Member States may request the Commission to grant a derogation, after consulting the Scientific Committee for Consumer Safety (SCCS), if an ingredient in wide use which cannot be replaced gives rise to serious concerns.

Committee procedure

The Commission shall be assisted by the Standing Committee on Cosmetic Products.

Context

This Regulation recasts Directive 76/768/EEC due to the many amendments made to it and the new amendments that were required.

The new Regulation shall apply in 2013. However, some of its provisions will apply from 1 December 2010: they concern substances which are carcinogenic, mutagenic or toxic for reproduction (classified as CMR).

Key terms
  • Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
  • Toxicokinetics: study of the long-term effects of toxic substances in the body.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1223/2009

11.7.2013

1.12.10 (Articles 15 paragraphs 1 and 2, Articles 14, 16, 31 and 32)

11.1.2013 (Article 16, paragraph 3, second section)

OJ L 342 of 22.12.2009


Another Normative about Cosmetic products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Food safety > Animal welfare

Cosmetic products (until 2013)

Document or Iniciative

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Cosmetics Directive) [See amending act(s)].

Summary

The free movement of cosmetic products within the European market cannot be restricted or prohibited by Member States if these products are not dangerous to human health under normal or foreseeable conditions of use.

However, if a cosmetic product conforming to this Directive constitutes a danger to human health, the Member State of the territory on which the product is marketed may take restrictive or prohibitive measures. In this instance, it informs the other Member States and the Commission so that appropriate measures can be taken throughout the European Union (EU).

Ingredients and composition

The Directive determines the list of substances which are prohibited in the composition of cosmetic products (Annex II) and the substances which are subject to restrictions or specific conditions of use (Annex III).

The Directive also contains lists of authorised colourings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII).

Labelling

Containers and/or packaging must specifically mention, in indelible, easily legible and visible characters:

  • the name and address of the manufacturer or of the person responsible for marketing the product;
  • the nominal contents at the time of packaging, by weight or by volume;
  • the date of minimum durability indicated for products with a minimum durability of less than 30 months;
  • the period of time after opening for which the product can be used for products with a minimum durability of more than 30 months (indicated with the symbol representing an open pot of cream);
  • the function of the product and particular precautions for use;
  • the batch number.

This information must be in the official language(s) of the respective Member State.

Moreover, the labelling must contain a list of ingredients. Perfume and aromatic compositions are designated by the words “perfume” or “aroma”, except where these have been identified as a significant cause of allergic reactions.

Market surveillance

Member States are responsible for monitoring their market. To this end, they check the safety of products manufactured or imported in the EU. Furthermore, they also ensure that the characteristics attributed to cosmetic products are not deceptive.

The manufacturer, the importer or the person responsible for marketing the product must inform the national competent authorities when a product is imported into the EU for the first time.

Animal testing

The Directive puts an end to animal testing by imposing bans on:

  • testing finished cosmetic products and ingredients on animals (testing ban);
  • marketing finished cosmetic products which have been tested on animals or which contain ingredients that have been tested on animals (marketing ban).

With regard to repeated-dose toxicity tests, reproductive toxicity tests, and toxicokinetics, the marketing prohibition applies from 11 March 2013. This prohibition is applicable regardless of the availability of alternative test methods.

Context

This Directive is replaced by Regulation (EC) No 1223/2009 from 11 July 2013.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 76/768/EEC

30.7.1976

30.1.1978

OJ L 262 of 27.9.1976

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 79/661/EEC

26.7.1979

30.7.1979

OJ L 192 of 31.7.1979

Directive 82/368/EEC

19.5.1982

31.12.1983

OJ L 167 of 15.6.1982

Directive 83/574/EEC

4.11.1983

31.12.1984

OJ L 332 of 28.11.1983

Directive 88/667/EEC

14.1.1989

31.12.1989

OJ L 382 of 31.12.1988

Directive 89/679/EEC

3.1.1990

3.1.1990

OJ L 398 of 30.12.1989

Directive 93/35/EEC

23.6.1993

14.6.1995

OJ L 151 of 23.6.1993

Directive 2003/15/EC

11.3.2003

11.9.2004

OJ L 66 of 11.3.2003

Successive amendments and corrections to Directive 76/768/EEC have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Non-inclusion of ingredients on labelling

Commission Directive 95/17/ECof 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non- inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

Inventory and common nomenclature of ingredients

Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products [Official Journal L 132 of 1.6.1996].

Checking the composition of cosmetic products

First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 87/143/EEC, Official Journal L 57 of 27.2.1987].

Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the Laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 90/207/EEC, Official Journal L 108 of 28.4.1990].

Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 291 of 24.10.1983].

Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 295 of 7.11.1985].

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic products [OJ L 231 of 14.9.1993].

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 178 of 28.7.1995].

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 213 of 22.8.1996].


Another Normative about Cosmetic products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Internal market > Pharmaceutical and cosmetic products

Cosmetic products (until 2013)

Document or Iniciative

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Cosmetics Directive) [See amending act(s)].

Summary

The free movement of cosmetic products within the European market cannot be restricted or prohibited by Member States if these products are not dangerous to human health under normal or foreseeable conditions of use.

However, if a cosmetic product conforming to this Directive constitutes a danger to human health, the Member State of the territory on which the product is marketed may take restrictive or prohibitive measures. In this instance, it informs the other Member States and the Commission so that appropriate measures can be taken throughout the European Union (EU).

Ingredients and composition

The Directive determines the list of substances which are prohibited in the composition of cosmetic products (Annex II) and the substances which are subject to restrictions or specific conditions of use (Annex III).

The Directive also contains lists of authorised colourings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII).

Labelling

Containers and/or packaging must specifically mention, in indelible, easily legible and visible characters:

  • the name and address of the manufacturer or of the person responsible for marketing the product;
  • the nominal contents at the time of packaging, by weight or by volume;
  • the date of minimum durability indicated for products with a minimum durability of less than 30 months;
  • the period of time after opening for which the product can be used for products with a minimum durability of more than 30 months (indicated with the symbol representing an open pot of cream);
  • the function of the product and particular precautions for use;
  • the batch number.

This information must be in the official language(s) of the respective Member State.

Moreover, the labelling must contain a list of ingredients. Perfume and aromatic compositions are designated by the words “perfume” or “aroma”, except where these have been identified as a significant cause of allergic reactions.

Market surveillance

Member States are responsible for monitoring their market. To this end, they check the safety of products manufactured or imported in the EU. Furthermore, they also ensure that the characteristics attributed to cosmetic products are not deceptive.

The manufacturer, the importer or the person responsible for marketing the product must inform the national competent authorities when a product is imported into the EU for the first time.

Animal testing

The Directive puts an end to animal testing by imposing bans on:

  • testing finished cosmetic products and ingredients on animals (testing ban);
  • marketing finished cosmetic products which have been tested on animals or which contain ingredients that have been tested on animals (marketing ban).

With regard to repeated-dose toxicity tests, reproductive toxicity tests, and toxicokinetics, the marketing prohibition applies from 11 March 2013. This prohibition is applicable regardless of the availability of alternative test methods.

Context

This Directive is replaced by Regulation (EC) No 1223/2009 from 11 July 2013.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 76/768/EEC

30.7.1976

30.1.1978

OJ L 262 of 27.9.1976

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 79/661/EEC

26.7.1979

30.7.1979

OJ L 192 of 31.7.1979

Directive 82/368/EEC

19.5.1982

31.12.1983

OJ L 167 of 15.6.1982

Directive 83/574/EEC

4.11.1983

31.12.1984

OJ L 332 of 28.11.1983

Directive 88/667/EEC

14.1.1989

31.12.1989

OJ L 382 of 31.12.1988

Directive 89/679/EEC

3.1.1990

3.1.1990

OJ L 398 of 30.12.1989

Directive 93/35/EEC

23.6.1993

14.6.1995

OJ L 151 of 23.6.1993

Directive 2003/15/EC

11.3.2003

11.9.2004

OJ L 66 of 11.3.2003

Successive amendments and corrections to Directive 76/768/EEC have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Non-inclusion of ingredients on labelling

Commission Directive 95/17/EC

of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non- inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

Inventory and common nomenclature of ingredients

Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products [Official Journal L 132 of 1.6.1996].

Checking the composition of cosmetic products

First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 87/143/EEC, Official Journal L 57 of 27.2.1987].

Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the Laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 90/207/EEC, Official Journal L 108 of 28.4.1990].

Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 291 of 24.10.1983].

Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 295 of 7.11.1985].

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic products [OJ L 231 of 14.9.1993].

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 178 of 28.7.1995].

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 213 of 22.8.1996].

Substances affecting the ozone layer

Substances affecting the ozone layer

Outline of the Community (European Union) legislation about Substances affecting the ozone layer

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Environment > Air pollution

Substances affecting the ozone layer

Document or Iniciative

Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer.

Summary

This Regulation replaces Regulation (EC) No 2037/2000. It brings the Community rules into line with technical developments and changes made to the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer. It therefore enables the European Union (EU) to continue its worldwide action to protect the ozone layer and guarantee its recovery.

Scope

This Regulation covers:

  • controlled substances such as chlorofluorocarbons (CFCs), halons, carbon tetrachloride, methyl bromide, hydrochlorofluorocarbons (HCFCs), etc. (see Annex I);
  • new substances (see Annex II);
  • products and equipment containing or relying on such substances.

Prohibitions

The production, placing on the market and use of controlled substances or products and equipment containing these substances shall be prohibited, with the exception of certain uses as feedstock * or process agents *, or laboratory and analytical uses.

The placing on the market and use of fire protection systems and fire extinguishers containing controlled substances, particularly halons, shall be prohibited.

Derogations

Controlled substances may be produced, placed on the market and used as feedstock or as process agents. These substances may also be used for laboratory or analytical uses. The quantity annually authorised shall be restricted by a system of quotas. Producers and importers must have a licence which is granted for a limited period by the competent authority of the Member State concerned.

Hydrochlorofluorocarbons (HCFCs) shall be phased out. No HCFCs may be produced after 31 December 2019.

The use of methyl bromide has been prohibited since 18 March 2010, except in an emergency, to prevent the spread of pests or disease. However, this derogation applies only for a period not exceeding 120 days and a quantity not exceeding 20 tonnes.

Halons may be placed on the market and used for critical uses (see Annex VI).

Any producer or importer authorised to use or place controlled substances on the market may transfer those rights to other producers or importers of such substances within the Community. Any transfer shall be notified in advance to the Commission.

A producer may also be authorised to exceed established levels of production, on condition that the maximum level of national production is not exceeded.

Trade

Imports and exports of controlled substances and of products and equipment containing such substances shall be prohibited.

Nevertheless, derogations exist for certain uses of controlled substances or for their destruction according to appropriate methods.

Imports and exports shall be subject to the issue of a licence. Such licences shall be issued by the Commission using an electronic licensing system.

Control of substances

Undertakings must put in place systems for the recovery of controlled substances contained in:

  • refrigeration, air-conditioning and heat pump equipment;
  • equipment containing solvents;
  • fire protection systems and fire extinguishers.

Once recovered, these substances must be recycled, reclaimed or destroyed in an environmentally acceptable manner in order to prevent their release into the atmosphere.

Undertakings must also take measures to avoid any risk of leakage or release of controlled substances. Any undertaking which operates equipment containing such substances must carry out regular checks for leakage. If leakage is detected, the undertaking must repair it as soon as possible and in any case within 14 days after detection.

Context

The ozone layer protects organisms living on Earth from ultraviolet (UV) radiation. In the 1980s, scientists observed a thinning of the stratospheric ozone layer due to emissions of man-made chemical substances. This depletion of the ozone layer is causing an increase in UV radiation which is dangerous for man, in whom it causes skin cancers in particular, and for ecosystems. The international community took rapid action by first of all adopting the Vienna Convention in 1985 and then the Montreal Protocol in 1987.

The Montreal Protocol requires signatories to phase out ozone-depleting substances according to a pre-established schedule. Twenty years after its adoption, the Montreal Protocol represents a model multilateral environmental agreement.

Key terms of the Act
  • Feedstock: any controlled substance or new substance that undergoes chemical transformation in a process in which it is entirely converted from its original composition and whose emissions are insignificant.
  • Process agents: controlled substances used as chemical process agents in the applications listed in Annex III.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1005/2009

1.1.2010

30.6.2011

OJ L 286 of 31.10.2009

Subsequent amendments and corrections to Regulation (EC) No 1005/2009 have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Commission Decision 2010/209/EU of 26 March 2010 on the allocation of import quotas for controlled substances for the period 1 January to 31 December 2010 under Regulation (EC) No 1005/2009 of the European Parliament and of the Council [Official Journal L 89 of 9.4.2010].

Substances which damage the ozone layer

Substances which damage the ozone layer

Outline of the Community (European Union) legislation about Substances which damage the ozone layer

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Other

Substances which damage the ozone layer

To protect human health and the environment, the European Union wishes to limit and monitor the production, marketing and use of substances which deplete the ozone layer within the Community, and exports of those substances to third countries.

Document or Iniciative

Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer [See amending acts].

Summary

Regulation (EC) No 2037/2000 replaced Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer, so as to adapt the Community rules to the technical developments which had occurred since that Regulation was adopted and in line with the changes made in 1995, 1997 and 1999 to the Montreal Protocol on Substances that Deplete the Ozone Layer. In laying down stricter control provisions than those of Regulation (EC) No 3093/94 and the Montreal Protocol, it takes into account the increasing availability of products that can replace those which deplete the ozone layer.

Scope

The Regulation applies to:

  • the production, importation, exportation, placing on the market, use, recovery, recycling, reclamation and destruction of chlorofluorocarbons (CFCs), other fully halogenated chlorofluorocarbons, halons, carbon tetrachloride, 1,1,1-trichloroethane, methyl bromide (MBr), hydrobromofluorocarbons, hydrochlorofluorocarbons (HCFCs) and bromochloromethane, hereinafter referred to as “regulated substances”, and, in certain cases, products or equipment containing these substances;
  • the information to be reported concerning these substances;
  • inspections and penalties;
  • new substances.

Bans and restrictions on regulated substances within the EU

The Regulation provides for a phased restriction on the use, placing on the market, production and importation of virgin HCFCs, with the deadline for final elimination set at:

  • 31 December 2009 for the placing on the market, use and importation of HCFCs. Many uses (and imports) of HCFCs, e.g. in aerosols, as refrigerants or as solvents, were, with a few exceptions, banned from the date on which the Regulation entered into force;
  • 1 January 2015 for all HCFCs, including recovered substances;
  • 31 December 2025 for the production of HCFCs.

As regards CFCs, other fully halogenated chlorofluorocarbons, halons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobromofluorocarbons and bromochloromethane, the placing on the market, use, production and importation of these substances were banned from the date on which the Regulation entered into force. The ban does not apply to products and equipment produced before the Regulation entered into force.

Under the Regulation, the placing on the market, use and production of methyl bromide will be reduced from 1999 and completely banned from 31 December 2004 and a ban placed on use by undertakings as from 31 December 2005.

Furthermore, the production, release for free circulation, inward processing, placing on the market and use of new substances listed in Annex II to the Regulation are prohibited. The Commission may make proposals to include in Annex II any new substances with significant ozone-depleting potential.

Exceptions and exemptions

By way of exemption, the Regulation provides for the possibility of regulated substances being placed on the market and used. A restriction (quota) applies to the quantity which may be produced, depending on the quantity of the substance on the market or used during a reference year.

An exception to the ban on production and importation is provided in the case of essential uses (as defined in the 1987 Montreal Protocol) of CFCs, other fully halogenated CFCs, halons, carbon tetrachloride and 1,1,1-trichloroethane and critical uses of methyl bromide. These substances may also be produced or imported where it is impossible to obtain them from recycling or to find a suitable substitute product. What constitutes an essential or critical use will be decided by the competent authorities in each Member State (in the case of methyl bromide) or by the Commission, taking account of proposals from the Member States (in the case of other substances). The Regulation also allows the placing on the market and use of halons that have been recovered, recycled or reclaimed in existing fire protection systems until 31 December 2002, and the placing on the market and use of halons for critical uses in accordance with Annex VII.

Regulation (EC) No 2038/2000 amended the main Regulation, allowing temporary export authorisation to be granted for metered dose inhalers and medical drug pumps.

To the extent allowed by the Montreal Protocol, and for reasons relating to industrial restructuring within a Member State, between Member States or with a third country under the Protocol, a producer of one of the regulated substances may also be authorised to exceed the production limits laid down, provided the maximum level of production for the Community as a whole is not exceeded.

In an emergency, where the proliferation of certain parasites or diseases makes it necessary, the temporary use (for no more than 120 days) of methyl bromide is authorised by way of an exception to the abovementioned general rule. The amount used may not exceed 20 tonnes.

Any producer or importer who is authorised to place on the market or to use the regulated substances may transfer these rights to other producers or importers of those substances in the Community. The Commission must be given advance notice of any such transfer.

Regulated substances may be put into free circulation or subjected to inward processing only upon presentation of an import licence and, in the case of release for free circulation, subject to quantitative limits. Import licences will be issued by the Commission. The free circulation or inward processing of regulated substances and of products containing such substances and originating in States which are not parties to the Montreal Protocol will be prohibited.

Furthermore, customs authorities, the producers, importers and exporters of regulated substances and users who have been granted exceptional authorisation to use these substances will be obliged to inform and notify the Commission. Before 31 March each year, they must send specific data on each regulated substance.

Rules on exports

The Regulation introduces a general ban on exports of regulated substances. However, exports of substances other than methyl bromide and HCFCs to States which are parties to the Montreal Protocol will be authorised (under an export licence issued by the Commission) to the extent allowed by the Montreal Protocol, and if such exports are necessary to meet those States’ basic or essential domestic requirements. Exports of (products containing) methyl bromide and HCFCs to States which are not parties to the Montreal Protocol may, in exceptional cases where those States have fully complied with the Protocol, be authorised by the Commission, after consulting a committee composed of representatives of the Member States. The Council may alter the Commission’s decision.

Other exemptions allow the exportation of regulated substances, including controlled substances for feedstock and processing-agent uses, recovered, recycled and reclaimed halons intended for critical uses in accordance with Annex VII until 31 December 2009, metered dose inhalers and delivery systems with temporary authorisation, and certain used products and equipment containing rigid insulating foam or skin foam made from CFCs.

Recovery of regulated substances

The Member States must introduce systems for recovering, for the purposes of recycling, reclamation or ecologically acceptable destruction, CFCs, other fully halogenated CFCs, halons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobromofluorocarbons, HCFCs and bromochloromethane contained in:

  • refrigeration and air conditioning equipment and heat pumps (except for household freezers and refrigerators up until 31 December 2001);
  • equipment containing solvents;
  • fire protection equipment and fire extinguishers.

Leakage of regulated substances

To prevent leakage of regulated substances, Member States were required to lay down the minimum training requirements for personnel responsible for maintaining equipment containing those substances by 31 December 2001. The Commission is to assess the measures taken by the Member States and, where appropriate, propose measures concerning minimum qualification requirements.

All possible measures must be taken to avoid and reduce leakage of regulated substances. The Commission must, as appropriate, disseminate notes describing best environmental practice and best available technology for the prevention of leakage.

Penalties

The Member States were required to lay down penalties for non-compliance with the Regulation and notify them to the Commission by 31 December 2000.

Base date for the allocation of quotas

Regulation (EC) No 2039/2000 amended the base year laid down in Regulation (EC) No 2037/2000 for the allocation of HCFC quotas so as to take account of changes in the market with respect to importers. The new base year was 1999. This base date was amended further by Regulation (EC) No 1366/2006 to take account of the Member States that joined the European Union on 1 May 2004. For the undertakings from those Member States only, the average market share for 2002 and 2003 was laid down as the new basis.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 2037/2000 30.9.2000 OJ L 244 of 29.9.2000
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 2038/2000 30.9.2000 OJ L 244 of 29.9.2000
Regulation (EC) No 2039/2000 30.9.2000 OJ L 244 of 29.9.2000
Decision 2003/160/EC 8.3.2003 OJ L 65 of 8.3.2003
Regulation (EC) No 1804/2003 5.11.2003 OJ L 265 of 16.10.2003
Decision 2004/232/EC 10.3.2004 OJ L 71 of 10.3.2004
Regulation (EC) No 2077/2004 24.12.2004 OJ L 359 of 4.12.2004
Regulation (EC) No 29/2006 31.1.2006 OJ L 6 of 11.1.2006
Regulation (EC) No 1366/2006 26.9.2006 OJ L 264 of 25.9.2006
Regulation (EC) No 1784/2006 25.12.2006 OJ L 337 of 5.12.2006
Regulation (EC) No 1791/2006 1.1.2007 OJ L 363 of 20.12.2006

Related Acts

Proposal for a Regulation of the European Parliament and of the Council of 1 August 2008 on substances that deplete the ozone layer (recast) [COM(2008) 505 final – Not published in the Official Journal].
This proposal aims to recast and simplify the Regulation (EC) No 2037/2000 with the aim of improving its implementation, reducing administrative costs and integrating the adjustments of the 2007 Montreal Protocol, specifically regarding the timetable for the phasing out of hydrochlorofluorocarbons (HCFCs). The new Regulation plans additional measures to prevent the illegal trade and use of substances which weaken the ozone layer and to improve the implementation and control of the Directive framework on waste, with regard to the recycling or disposal of these substances

Regulation (EC) No 842/2006 of the European Parliament and of the Council of 17 May 2006 on certain fluorinated greenhouse gases [Official Journal L 161 of 14.6.2006].
The European Union lays down rules for the containment, use, recovery and destruction of certain fluorinated greenhouse gases, the labelling of products and equipment containing them, the reporting of information on them, the prohibition of the placing on the market of products and equipment containing them, and the training and certification of personnel in relation to them.

Communication of 23 October 1998 from the Commission to the European Parliament and the Council: Strategy for the phaseout of CFCs in metered dose inhalers [COM(98) 603 final – Official Journal C 355 of 20.11.1998].
The Commission sets out a Community strategy to eliminate chlorofluorocarbons (CFCs) from metered dose inhalers.

NOTICES TO UNDERTAKINGS

Notice to importers in the European Union and Bulgaria and Romania that propose to import in 2007 controlled substances that deplete the ozone layer under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer [Official Journal C 171 of 22.7.2006]

Notice to proposed exporters from the European Union and Bulgaria and Romania in 2007 of controlled substances that deplete the ozone layer under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer [Official Journal C 171 of 22.7.2006]

Notice to users of controlled substances in the European Union and Bulgaria and Romania allowed for essential uses in the Community in 2007 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer [Official Journal C 171 of 22.7.2006]

ALLOCATION OF QUOTAS

Commission Decision 2007/211/EC of 27 March 2007 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2006 pursuant to Regulation (EC) No 2037/2000 of the European Parliament and of the Council [Official Journal L 94 of 4.4.2007].

Commission Decision 2007/382/EC of 29 May 2007 on the allocation of import quotas for controlled substances for the period 1 January to 31 December 2007 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council [Official Journal L 142 of 5.6.2007].

Commission Decision 2007/386/EC of 5 June 2007 determining the quantities of methyl bromide permitted to be used for critical uses in the Community from 1 January to 31 December 2007 under Regulation (EC) No 2037/2000 on substances that deplete the ozone layer [Official Journal L 143 of 6.6.2007].

MONTREAL PROTOCOL

Recommendation [SEC(2004) 1376]
Recommendation of 12 November 2004 from the Commission to the Council for the European Community to negotiate an amendment to Article 2(10) of the Montreal Protocol on substances that deplete the ozone layer, as well as certain adjustments to the Protocol.

Council Decision 2002/215/EC of 4 March 2002 concerning the conclusion of the Fourth Amendment to the Montreal Protocol on substances that deplete the ozone layer [Official Journal L 72 of 14.3.2002].
This amendment adds the following restrictions to the Protocol:

  • an end to HCFC production in developed countries by 2004;
  • an end to trade in HCFCs with countries outside the Protocol by 2016;
  • a ban on bromochloromethane;
  • compulsory communication of the quantity of methyl bromide used for quarantine and pre-shipment.

Council Decision 2000/646/EC of 17 October 2000 concerning the conclusion of the amendment to the Montreal Protocol on substances that deplete the ozone layer [Official Journal L 272 of 25.10.2000].
The most significant provisions of the Montreal amendment concern trade with third countries, including:

  • a ban on imports or exports of methyl bromide from or to States which are not parties to the Protocol;
  • a ban on exports, from States not party to the Protocol, of used, recycled and recovered substances regulated by the Protocol;
  • compulsory licensing system for imports and exports of substances that deplete the ozone layer.

Council Decision 94/68/EC of 2 December 1993 concerning the conclusion of the amendment to the Montreal Protocol on substances that deplete the ozone layer [Official Journal L 33 of 7.2.1994].

Council Decision 91/690/EEC of 12 December 1991 concerning the conclusion of the amendment to the Montreal Protocol on substances that deplete the ozone layer as adopted in June 1990 in London by the Parties to the Protocol [Official Journal L 377 of 31.12.1991].

Council Decision 88/540/EEC of 14 October 1988 concerning the conclusion of the Vienna Convention for the protection of the ozone layer and the Montreal Protocol on substances that deplete the ozone layer [Official Journal L 297 of 31.10.1988].
The Montreal Protocol was signed on 16 September 1987. It entered into force in the European Community on 16 March 1989.

Biocides

Biocides

Outline of the Community (European Union) legislation about Biocides

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Biocides (until 1 September 2013)

Document or Iniciative

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market [See amending act(s)].

Summary

Scope

The Directive concerns:

  • the authorisation and placing on the market of biocidal products in the Member States;
  • the mutual recognition of authorisations within the Community;
  • the establishment at Community level of a list of active substances which may be used in biocidal products.

The Directive applies to biocidal products, i.e. non-agricultural pesticides as defined in Article 2 of the Directive. An exhaustive list of the products covered by this Directive is annexed below.

The Directive does not apply to products falling within the scope of the following legislative acts:

  • Directive 2001/83/EC (medicinal products for human use);
  • Directive 2001/82/EC (veterinary medicinal products);
  • Regulation (EC) No 726/2004 (European Medicines Agency);
  • Directive 90/385/EEC (active implantable medical devices)
  • Directive 93/42/EEC (medical devices);
  • Directive 98/79/EC (in vitro diagnostic medical devices);
  • Regulation (EC) No 1333/2008 (food additives)
  • Regulation (EC) No 1334/2008 (flavourings in foodstuffs);
  • Regulation (EC) No 1935/2004 (materials and articles intended to come into contact with foodstuffs);
  • Directive 90/167/EEC (medicated feedingstuffs);
  • Regulation (EC) No 767/2009 (feed);
  • Regulation (EC) No 1831/2003 (use of additives in animal nutrition);
  • Regulation (EC) No 1223/2009 (cosmetic products);
  • Regulation (EC) No 1107/2009 (plant protection products).

Obligations of the Member States

Member States must ensure the authorisation, classification, labelling, packaging and proper use of the biocidal products in line with this Directive. Proper use includes measures necessary to keep the use of biocidal products to a minimum as well as an obligation to ensure that their use in the workplace is in compliance with the directives on health and safety protection for workers. Member States must appoint one or more competent authorities responsible for complying with the obligations imposed on them under this Directive, including granting authorisations and receiving information relating to biocidal products so as to be able to meet any medical demand.

Each quarter Member States must inform the other Member States and the Commission of any biocidal products which have been registered and authorised within their territory or for which an authorisation or registration has been refused, modified, renewed or cancelled.

Every three years since 2003, Member States have submitted reports to the Commission in which they provide information on any poisonings involving biocidal products.

Principle of mutual recognition of authorisations

The authorisation system is based on the principle of mutual recognition of authorisations. Under this principle, a biocidal product that has already been authorised or registered in one Member State must be authorised in another Member State within 120 days or registered within 60 days of an application being received by the other Member State.

However, there are a number of derogations from mutual recognition:

  • The Member State may request that certain conditions relating to the classification, labelling and packaging of biocidal products be adapted under certain circumstances. These involve the quantity of the target species in the territory of the Member State, the degree of resistance of the target organism to the biocidal product and the circumstances under which it is used;
  • Where a Member State believes that a low-risk biocidal product which has been registered in another Member State does not comply with the definition set out in the Directive it may provisionally refuse to register it. In such cases it must notify the competent authority responsible for verifying the dossier;
  • Where a Member State believes a biocidal product authorised by another Member State does not meet the conditions for granting the authorisation and proposes to refuse the authorisation or registration it must notify the Commission, the other Member States and the applicant. The case will then be referred to the Standing Committee on Biocidal Products for a final decision which must be unanimously accepted;
  • Unless otherwise stated in the Treaty, Member States may refuse to grant mutual recognition of authorisations issued for types of products used against vermin, fish and birds, provided that such action is justifiable and does not frustrate the objectives of the Directive.

Conditions governing the granting of authorisations

It is compulsory to issue product marketing authorisation, subject to certain derogations in the case of low-risk products. The Member States may authorise a biocidal product only if:

  • its active substances are listed in the Annexes to the Directive and the requirements set out in the Annexes are met;
  • it is established that:
    • the biocidal product is sufficiently effective,
    • it has no unacceptable effects on the target organisms,
    • it has no unacceptable effects on human health or animal health or on surface water or groundwater,
    • it has no unacceptable effect on the environment;
  • the nature and quantity of its active substances can be determined according to the requirements listed in the Annexes to the Directive;
  • its physical and chemical properties have been deemed acceptable for purposes of appropriate use, storage and transport of the product.

A biocidal product classified as toxic, carcinogenic and mutagenic or toxic for reproduction is not authorised for marketing to the general public.

Authorisations may be reviewed at any time during the period for which they have been granted.

Placing on the market of active substances

An active substance for use in biocidal products may be placed on the market if:

  • a dossier has been submitted to a Member State accompanied by a declaration that the active substance is intended for inclusion in a biocidal product. This condition applies to active substances which did not have an authorisation to be placed on the market before 14 May 2000;
  • the active substance is classified, packaged and labelled in accordance with Directive 67/548/EEC which is applicable until 1 June 2015.

All active substances approved for inclusion in biocidal products are listed in Annex I or IA to the Directive. The maximum period during which a substance may be listed in the Annex is ten years.

Inclusion of a new active substance in the Annex

With a view to listing a new active substance in Annex I, IA or IB to the Directive, the Commission presents a proposal to the Standing Committee. The proposal is based on an evaluation of the substance carried out with the help of data supplied by the applicant.

Cancellation of an authorisation

An authorisation is cancelled if:

  • the active substance is no longer included in Annex I or IA to the Directive;
  • the conditions for obtaining the authorisation are no longer satisfied;
  • false particulars were supplied with the application for authorisation;
  • at the request of the authorisation holder.

Modification of an authorisation

An authorisation may be modified:

  • where a Member State considers that this is necessary to protect health and the environment;
  • at the request of the holder.

It is the responsibility of the holder of an authorisation for a biocidal product to pass on immediately to the competent authority any information of which he is aware concerning an active substance or a biocidal product containing it and which may affect continuing authorisation.

Procedure for requesting authorisation

An application for authorisation should come from the person initially responsible for placing a biocidal product on the market in a Member State and should be addressed to the competent authority in that Member State. In order to obtain the authorisation, the applicant must provide the following:

  • a dossier or letter of access concerning the biocidal product and containing the information specified in Annex IIB, IIIB or IVB depending on the type of biocidal product. The required information will contain, for example: the applicant’s name and address, the name and composition of the product, proposed uses, protective measures to be taken, among others. Dossiers for low-risk biocidal products are less detailed;
  • a dossier or letter of access for each active substance contained in the biocidal product and containing the information specified in Annexes IIA, IIIA and IVA.

The authorisation to place biocidal products on the market and entries of substances in Annex I, IA or IB are subject to the payment of a charge.

Member States may only use the information contained in the dossier accompanying the application for authorisation for the benefit of another applicant on certain conditions, one of which stipulates that the written agreement of the first applicant must be obtained.

Provisions applicable to a biocidal product that has already been authorised

Applicants for authorisation to place products on the market may use information provided by a previous applicant, in so far as the subsequent applicant can provide evidence that the product is similar and its active substances are the same as in the product previously authorised.

Before carrying out experiments involving vertebrate animals, an applicant for authorisation of a biocidal product must enquire of the competent authority of the Member State to which they intend to submit their application:

  • whether the biocidal product in question is similar to a biocidal product already authorised;
  • as to the name and address of the holder of the authorisation.

The applicant and holder or holders of former authorisations are encouraged to come to an agreement on the shared use of information to avoid duplicating the testing on vertebrate animals.

Exemptions

The Directive provides for the possibility of exemption from the requirements for placing biocidal products on the market. A Member State may temporarily authorise placing biocidal products on the market which do not comply with the provisions of the Directive for limited and controlled use if such measures appear necessary due to unforeseen danger not able to be contained by other means.

Role of the Commission

Following the adoption of the Directive, the Commission is to embark on a programme of work, systematically examining the risks associated with all active substances authorised for inclusion in biocidal products. The programme has been set up under a Regulation adopted by the Standing Committee on Biocidal Products, and will run for ten years. Its task is to examine all active substances already available on the market as of 14 May 2000 in the form of active substances for a biocidal product, with the exception of products used for purposes of research, science and product development.

Not more than two years prior to the completion of the programme of work, the Commission will send a progress report on the implementation of the programme to the European Parliament and the Council.

To further improve implementation of the Directive, the Commission must prepare technical guidelines which are to be published in the Official Journal of the European Communities.

Research and development

Experiments or tests carried out for the purposes of research or development involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product are subject to several conditions, including an obligation to obtain authorisation from the competent authority if the tests are likely to have harmful effects on human or animal health or on the environment.

Classification, packaging and labelling

Biocidal products are classified, packaged and labelled in accordance with Directive 1999/45/EC on the classification, packaging and labelling of dangerous preparations which is applicable until 1 June 2015. However, in order to avoid any misunderstandings (confusion with foodstuffs or drinks, for example), the Directive lays down additional requirements with regard to the packaging and labelling of such products.

Safety measures

A system of specific information is introduced in order to enable professional and industrial users of biocidal products to take the necessary measures for the protection of the environment and health. This system must take the form of a data safety sheet provided by those responsible for placing the product on the market.

Confidentiality

The Directive allows the applicant to ask for certain sensitive information to be kept confidential from all persons other than the competent authorities and the Commission. Some information, however, (such as the name and address of the applicant, the physical and chemical properties of the biocidal product, etc.), cannot be included in this confidentiality clause.

Safeguard clause

The Directive allows the applicant to ask for certain sensitive information to be kept confidential from all persons other than the competent authorities and the Commission. Some information, however, (such as the name and address of the applicant, the physical and chemical properties of the biocidal product, etc.), cannot be included in this confidentiality clause.

Advertising

Marketing biocidal products is subject to certain conditions and must be in particular accompanied by wording which makes clear that the product should be used with care.

Comitology

The Commission is assisted by a Standing Committee on Biocidal Products. The Committee operates according to a regulatory procedure in the case of certain tasks, such as taking decisions to grant or withhold a prohibition (safeguard clause) or according to a management procedure in other cases, such as the listing of an active substance in the Annex and granting confidentiality.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Directive 98/8/EC

14.5.1998

13.5.2000

OJ L 123 of 24.4.1998

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1882/2003

20.11.2003

OJ L 284 of 31.10.2003

Directive 2007/47/EC

11.10.2007

21.12.2008

OJ L 247 of 21.9.2007

Directive 2008/31/EC

21.3.2008

OJ L 81 of 20.3.2008

Directive 2009/107/EC

26.10.2009

14.5.2010

JO L 262 du 6.10.2009

The successive amendments and corrections to Directive 98/8/EC have been incorporated into the basic text. This consolidated version  is for reference purpose only.

LAST AMENDMENTS TO THE ANNEXES

Annex I – List of active substances with requirements agreed at community level for inclusion in biocidal products
Directive 2011/10/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/11/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/12/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/13/EU [Official Journal L 34 of 9.2.2011].

Related Acts

Evaluation of active substances

Directive 98/8/EC provides for an evaluation of all active substances already on the market as at 14 May 2000 in the form of active substances in biocidal products. The ten-year programme is divided into two phases: the first, which began in 2000, is concerned with the identification of the substances, and the second, which began in 2003, with their evaluation.

Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products [Official Journal L 228 of 8.9.2000].
The first phase of this Regulation adopted on 7 September 2000 aims to:

  • identify the relevant substances and specify which need to be evaluated with a view to their possible listing in Annex I, IA or IB to Directive 98/8/EC (active substances authorised for use in biocidal products);
  • identify the first priority list of active substances to be evaluated during the second phase of the programme (the existing active substances used in biocidal products of type 8 (wood preservatives) and type 14 (rodenticides)).

Producers should identify the active substances to the Commission not later than 18 months after the entry into force of this Regulation using the special software provided free of charge by the Commission. Should the producer or formulator wish to request the listing of an active substance in Annex I or IA to the Directive, notification rather than identification will be necessary. The producer or formulator is required to provide the Commission with the information specified in Annex II to the Regulation, using the special Commission software, within 18-months of the Regulation’s date of entry into force. The Commission, in cooperation with the Member States, will then decide whether to accept or reject the notification. If it is accepted, the notifier must provide all the data and information necessary evaluating the active substance with a view to its possible inclusion in the Annex to the Directive during the second phase of the review programme.

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market [Official Journal L 325 of 11.12.2007].
This Regulation replaces and repeals Regulation (EC) No 2032/2003 of 4 November 2003, which had been subject to successive amendments. These various amendments made it difficult to read, particularly the Annexes concerning lists of identified active substances (Annexes I and VII to Regulation EC No 2032/2003), notified substances (Annexes II, V and VIII), and identified but not notified active substances (Annex III).
Regulation (EC) No 1451/2007 thus rationalises these lists and consolidates their successive amendments:

  • by creating an Annexe I, corresponding to the list of existing active substances, i.e. substances that are known to have been placed on the market as active biocidal substances before 14 May 2000 (consolidation of Annexes I and VII to the previous Regulation);
  • by creating an Annexe II, corresponding to the list of active substances currently notified to the review programme, updated, indicating the name of the reporting Member State (consolidation of Annexes II, V and VIII to the previous Regulation);
  • by deleting the former Annex III to the previous Regulation EC No 2032/2003, since it was no longer of use.

Application of the legislation

Report from the Commission to the Council and the European Parliament of 8 October 2008 – Evaluation of the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market (submitted in accordance with Article 18 (5) of the Directive) and progress Report on the work programme referred to in Article 16(2) of the same Directive [COM(2008) 620 – Not published in the Official Journal].
The Directive set the foundations for improving the level of environmental and public health protection which is offered to European Union citizens in relation to biocidal products. During the five years prior to the effective start of the active substance review in 2004, the Commission, in cooperation with the Member States and industry, inventoried biocidal products on the market and put into place a structured procedure for the assessment and evaluation of the existing active substances.
The review programme will not be finalised by the date originally set, 14 May 2010, which also happens to be the date by which national rules for the placing on the market of biocidal products will cease to apply. Allowing the transitional period to elapse without completing the review programme for biocidal products,would mean that the harmonised rules of the Directive about product authorisation could not apply for all the biocidal products already on the market. If neither set of rules – harmonised or national – could apply, there would be a legal void with regard to the placing on the market of biocidal products. This could have negative effects on public health (if important biocidal products were withdrawn from the market) and would have severe adverse economic effects on all companies operating in the biocides sector.
Therefore, this Communication is accompanied by a proposal for the revision of the Directive which would extend the review programme, the transitional period, and certain provisions on data protection that accompany this period for an additional three years.


Another Normative about Biocides

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Food safety > Plant health checks

Biocides

Document or Iniciative

Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Summary

This Regulation applies to:

  • biocidal products *;
  • articles and materials treated * with biocidal products;
  • active substances.

A list of the products concerned can be found in Annex V to the Regulation.

Conditions for authorisation of biocidal products

For biocidal products, the following conditions must be met for authorisation:

  • the active substance are approved for the relevant product-type;
  • the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
  • the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
  • where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
  • where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.

An active substance shall be approved for a maximum initial period of 10 years if at least one biocidal product containing that active substance may be expected to meet the above criteria.

National authorisation and mutual recognition

The Regulation provides for harmonised procedures for the authorisation of biocidal products in the EU. Once a first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries. The authorisation shall be granted under identical terms and conditions.

Union authorisation

The centralised authorisation procedure will result in a Union authorisation which allows the industry to place biocidal products directly on the entire EU market without the need to obtain separate national authorisations or go through the mutual recognition procedure. This centralised authorisation is voluntary and if, for whatever reason, the applicant is not interested in a Union authorisation, he can instead apply for a national authorisation and, if appropriate, mutual recognition of that authorisation in other EU countries.

Simplified authorisation procedure

Certain biocidal products may be eligible for a simplified authorisation procedure, if the following conditions are met:

  • all the active substances contained in the biocide appear in and satisfy any restrictions in Annex I to this regulation;
  • the biocide does not contain any substance of concern or any nanomaterials;
  • the biocide is sufficiently effective;
  • the handling of the biocidal product and its intended use do not require personal protective equipment.

If the above conditions are met, applicants must submit applications to the European Chemicals Agency (ECHA), designating a competent authority to evaluate its application.

A biocidal product authorised by the above simplified procedure may be made available on the market in all EU countries without the need for mutual recognition. However, the authorisation holder must notify each EU country no later than 30 days before placing the product on the market within that country. The official language or languages of that country must be used on the product’s labelling, unless the country provides otherwise.

Treated articles

This Regulation extends the scope from previous legislation on biocides to now also cover articles which have been treated or which incorporate a biocidal product. Articles can only be treated with active substances which have been approved in the EU for that purpose. Manufacturers and importers of treated articles are required to label products when:

  • a claim is made that the treated article has biocidal properties;
  • the conditions of the approval of the active substance used to treat the article require specific labelling provisions to protect public health or the environment.
KEY TERMS USED IN THE ACT
  • Biocidal products: any substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
  • Treated article: any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 528/2012

17.7.2012

OJ L 167 of 27.6.2012


Another Normative about Biocides

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Food safety > Contamination and environmental factors

Biocides

Document or Iniciative

Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Summary

This Regulation applies to:

  • biocidal products *;
  • articles and materials treated * with biocidal products;
  • active substances.

A list of the products concerned can be found in Annex V to the Regulation.

Conditions for authorisation of biocidal products

For biocidal products, the following conditions must be met for authorisation:

  • the active substance are approved for the relevant product-type;
  • the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
  • the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
  • where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
  • where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.

An active substance shall be approved for a maximum initial period of 10 years if at least one biocidal product containing that active substance may be expected to meet the above criteria.

National authorisation and mutual recognition

The Regulation provides for harmonised procedures for the authorisation of biocidal products in the EU. Once a first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries. The authorisation shall be granted under identical terms and conditions.

Union authorisation

The centralised authorisation procedure will result in a Union authorisation which allows the industry to place biocidal products directly on the entire EU market without the need to obtain separate national authorisations or go through the mutual recognition procedure. This centralised authorisation is voluntary and if, for whatever reason, the applicant is not interested in a Union authorisation, he can instead apply for a national authorisation and, if appropriate, mutual recognition of that authorisation in other EU countries.

Simplified authorisation procedure

Certain biocidal products may be eligible for a simplified authorisation procedure, if the following conditions are met:

  • all the active substances contained in the biocide appear in and satisfy any restrictions in Annex I to this regulation;
  • the biocide does not contain any substance of concern or any nanomaterials;
  • the biocide is sufficiently effective;
  • the handling of the biocidal product and its intended use do not require personal protective equipment.

If the above conditions are met, applicants must submit applications to the European Chemicals Agency (ECHA), designating a competent authority to evaluate its application.

A biocidal product authorised by the above simplified procedure may be made available on the market in all EU countries without the need for mutual recognition. However, the authorisation holder must notify each EU country no later than 30 days before placing the product on the market within that country. The official language or languages of that country must be used on the product’s labelling, unless the country provides otherwise.

Treated articles

This Regulation extends the scope from previous legislation on biocides to now also cover articles which have been treated or which incorporate a biocidal product. Articles can only be treated with active substances which have been approved in the EU for that purpose. Manufacturers and importers of treated articles are required to label products when:

  • a claim is made that the treated article has biocidal properties;
  • the conditions of the approval of the active substance used to treat the article require specific labelling provisions to protect public health or the environment.
KEY TERMS USED IN THE ACT
  • Biocidal products: any substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
  • Treated article: any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 528/2012

17.7.2012

OJ L 167 of 27.6.2012

Stockholm Convention on persistent organic pollutants

Stockholm Convention on persistent organic pollutants

Outline of the Community (European Union) legislation about Stockholm Convention on persistent organic pollutants

Topics

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Environment > Air pollution

Stockholm Convention on persistent organic pollutants (POPs)

Document or Iniciative

Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants.

Summary

The Stockholm Convention seeks to limit pollution by persistent organic pollutants (POPs). It defines the substances in question, and also defines the rules governing the production, importing and exporting of those substances.

Definition

Persistent organic pollutants are chemical substances that possess certain toxic properties and, unlike other pollutants, resist degradation. POPs are particularly harmful for human health and the environment. They accumulate in living organisms, are transported by air, water and migratory species and accumulate in terrestrial and aquatic ecosystems. Pollution caused by POPs is a cross-border problem which makes international action is indispensable.

Scope

The Stockholm Convention covers 12 priority POPs produced intentionally or unintentionally. These substances are formed unintentionally by a wide variety of sources, such as residential combustion systems and waste incinerators.

These 12 priority POPs are aldrin, chlordane, dichlorodiphenyltrichlorethane (DDT), dieldrin, endrin, heptachlor, mirex, toxaphene, polychlorobiphenyls (PCBs), hexachlorobenzene, dioxins and furanes.

Initially the Convention aims at prohibiting production and use of nine POPs and minimising production and use of a tenth substance. In the case of the last two POPs, the objective is to minimise their unintentional production and release into the environment. The rules laid down in the Convention do not apply to quantities of a chemical to be used for laboratory-scale research.

Institutional bodies

Three bodies have been set up to implement the Convention at international level:

  • The Conference of the Parties: This is the principal body, consisting of all the Parties to the Convention plus, where appropriate, observers. It lays down the rules on the implementing procedures and is responsible for major decisions, such as addition of a new substance to the Convention and approval of exemptions;
  • The Persistent Organic Pollutants Review Committee: This committee, made up of specialists, examines proposals to add new substances to the Convention;
  • The Secretariat: This body is responsible principally for administrative tasks.

Import/export of POPs

The Convention provides for ending imports and exports of banned POPs. However, chemicals classified as POPs may be imported under certain circumstances:

  • for environmentally sound disposal of existing POPs (destruction of waste, etc.);
  • if an exemption has been granted authorising production and use of the substances in question.

Exports are authorised:

  • for environmentally sound disposal of existing POPs (destruction of waste, etc.);
  • to a party granted an exemption from the Convention to use the substance in question;
  • to States which have not signed the Convention.

In the latter case, the importing State must provide annual certification to the exporting Party. This certificate must specify, inter alia, the intended use of the chemical and including a commitment from the importing State to protect human health and the environment and to take waste management measures, including action to ensure irreversible elimination of the substance classified as a POP.

Unintentional production of POPs

The goal is to minimise and, where feasible, eliminate unintentional production and release of POPs. To this end, the Parties to the Convention are required to develop a national, regional or subregional action plan. This must form part of the overall plan for implementing the Convention. The plan must include an evaluation of releases, an evaluation of the efficacy of the existing laws and policies on management of such releases and strategies for meeting the objectives of the Convention.

The development and use of modified or substitute materials, product and processes must be encouraged in order to avoid unintentional production of POPs. The Convention includes general guidelines on best available techniques and best environmental practices for preventing or minimising releases. It also provides for measures to reduce or eliminate releases containing POPs from stockpiles and wastes.

Exemptions

The Convention allows certain exemptions from the provisions on elimination or minimisation of production or use of these substances and, consequently, from the rules on imports and exports. Such exemptions are specific to each POP and are defined, case by case, in the Annexes to the Convention.

The exemptions are entered in a register open to the public and are valid for five years. They may be extended by the Conference of the Parties, based on a report submitted to the Conference by the Party concerned justifying the continuing need for the exemption. However, when there are no longer any Parties registered for a particular type of exemption, no new registrations will be accepted for that exemption.

Implementation by the Parties

The Parties must develop a plan for fulfilling their obligations under the Convention and transmit it to the Conference. To make it easier to exchange information, each Party must designate a national focal point. Since POPs are a cross-border issue, the Parties are encouraged to cooperate at various levels, including regional or subregional, in order to facilitate the preparation, application and updating of their plans.

It is also important to monitor POP trends in the environment and their effects on public health and to encourage research and development.

Addition of new substances

At the request of any Party, the Review Committee examines all proposals to add new POPs to those already listed under the Convention. Such requests must be accompanied by the specified information stating the reasons for the proposal. This includes proof of persistence, bioaccumulation, potential for spreading and of the adverse effects on human health and the environment. Where it is decided that a proposal meets the selection criteria, the Committee re-examines the proposal, taking account of any relevant additional information received, and draws up a draft description of the risks, and if required, a risk management assessment. On the basis of these assessments, the Committee recommends that the Conference of the Parties should or should not consider including the chemical in annexes A, B and/or C. The final decision is taken by the Conference of the Parties.

Financial resources and technical assistance

Each Party contributes to the financial resources for implementation of the Convention, notably via measures and activities at national or regional level forming part of implementation plans. Developing countries and countries with economies in transition could have financial and technical difficulties with application of the Convention. Developed countries should make their contribution via a mechanism set up by the Convention to attempt to resolve this problem by providing extra financial resources. Another possible form of aid for developing countries and economies in transition is the technological support provided by the developed countries.

Rules on information

Members of the public, politicians and the chemical industry must be kept informed and made aware of the risks posed by POPs and of the rules on the subject. Measures such as appropriate training for the individuals concerned are envisaged. Effective communication between the Parties is also essential, principally via the Secretariat for the Convention.

Settlement of disputes

Disputes between Parties over interpretation or application of the Convention are either settled by arbitration or referred to the International Court of Justice. The plaintiff may choose the procedure. However, if the plaintiff is a regional or economic integration organisation it must follow the arbitration procedure alone.

Failure to comply

The Convention will have a mechanism for identifying non-compliance with the Convention and procedures for dealing with such cases.

Withdrawal

Parties may withdraw from the Convention three years after it enters into force through a written withdrawal. A minimum period of one year from the receipt of the withdrawal notification by the depositary must elapse before such withdrawals can take effect.

Background

The Convention was adopted by 150 Governments, including those of the Member States of the European Union, and also by the Council, acting on behalf of the European Union, at a conference held in Stockholm from 22 to 23 May 2001.

The Convention entered into force on 17 May 2004.

The Stockholm Convention follows a series of measures taken at international level. In June 1998 the European Community signed the Aarhus Protocol on Persistent Organic Pollutants to the Geneva Convention on Long-range Transboundary Air Pollution (under the auspices of the United Nations Economic Commission for Europe (UN-ECE)). The Protocol currently covers 16 POPs, 12 of which come under this Convention.

This measure also fits into the broader context of the numerous international treaties and conventions concluded on the environment in recent years, such as the Rio Declaration on Environment and Development.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Decision 2006/507/EC

14.10.2004

OJ L 209, 31.7.2006

Related Acts

Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC [OJ L 158 of 30.4.2004].
This 2004 Regulation seeks to supplement the EU’s already substantial legislation on the substances on the lists and shows a willingness to go beyond international obligations, especially in the field of chemical substances and waste management.
The Regulation specifically concerns the production, placing on the market, use, discharge and elimination of substances which are banned or restricted under the Stockholm Convention on POPs, or the UN-ECE Protocol on POPs. It seeks to establish, at European level, requirements for effective implementation of these two international agreements.

Council Decision 2004/259/EC of 19 February 2004 concerning the conclusion, on behalf of the European Community, of the 1988 Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants [OJ L 81 of 19.3.2004].
This Decision approves the 1998 Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants.
This United Nations-Economic Commission for Europe (UN-ECE) Protocol was signed by the EU and its Member States in June 1998. It relates to the same 12 POPs as the Stockholm Convention and to four other additional substances (pentabromodiphenyl ether, chlordecone, hexabromobiphenyl and hexachlorocyclohexane). These POPs have significant adverse effects on health or the environment as a result of their persistence, their bioaccumulation and their long-range transboundary atmospheric transport. The Protocol’s ultimate aim is to eliminate discharges, emissions and leaks of POPs. The Protocol categorically prohibits the production and use of certain products (aldrin, chlordane, chlordecone, dieldrin, endrin, hexabromobiphenyl, mirex and toxaphene). It provides for the elimination of other products at a later stage (DDT, heptachlor, hexachlorobenzene and polychlorobiphenyls (PCBs)).

The Rotterdam Convention on the international trade in hazardous chemicals

The Rotterdam Convention on the international trade in hazardous chemicals

Outline of the Community (European Union) legislation about The Rotterdam Convention on the international trade in hazardous chemicals

Topics

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Environment > Environment: cooperation with third countries

The Rotterdam Convention on the international trade in hazardous chemicals

Document or Iniciative

Council Decision 2006/730/EC of 25 September 2006 on the conclusion, on behalf of the European Community, of the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade.

Regulation(EC) n° 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals.

Summary

The Rotterdam Convention was signed by the European Community on 11 September 1998. This Decision, approving the Rotterdam Convention on behalf of the European Community, is accompanied by a Council Regulation to implement the Convention’s provisions within the European Union (EU).

DECISION APPROVING THE ROTTERDAM CONVENTION

Fundamental principle

The Convention regulates the import and the export of certain hazardous chemicals and pesticides. It is based on the fundamental principle of Prior Informed Consent (PIC), meaning that under the Convention, a chemical listed in the Convention may only be exported with the importer’s prior consent. The Convention establishes a procedure to disseminate the decisions taken by the importing countries, thus implementing the PIC principle in the international trade in chemicals. It contains provisions requesting detailed information on the chemicals so that these decisions may be taken once data are available on the properties and the incidence of these products in particular on human health and the environment.

Products concerned

The Convention applies to banned or severely restricted chemicals and to extremely hazardous pesticide formulations. Over 30 chemicals are currently subject to the PIC procedure.

However, certain products are excluded from the scope of the Convention, namely:

  • narcotic drugs and psychotropic substances;
  • radioactive materials;
  • waste;
  • pharmaceuticals;
  • chemical weapons;
  • chemicals used as food additives;
  • food;
  • chemicals imported in quantities not likely to involve a risk provided they are imported for the purpose of research or analysis or by an individual for his or her own personal use.

Implementation of the Convention

Each Party must designate a national authority to ensure implementation at national and regional level. The Convention establishes a conference of the Parties which ensures implementation at international level and the evaluation of the Convention, including the approval of amendments. There is also a subsidiary body called the Chemical Review Committee (the Committee), which is responsible for analysing and assessing chemicals. The Secretariat is mainly responsible for coordination and administrative tasks.

Listing of hazardous chemicals and pesticides

Each Party must inform the Secretariat of any regulatory action adopted in respect of one or more chemicals or pesticides on its territory. Such notification must include information on the properties, identification and use of the chemical and its regulatory action. Where there are two notifications for the same chemical from at least two different regions, the Committee will review the information provided and, where appropriate, will recommend that the chemical in question be included in the list of chemicals subject to the Convention. Severely hazardous pesticides are subject to specific provisions. The Convention takes into consideration the fact that developing countries or countries with economies in transition have more limited means, and allows these countries to draw upon technical expertise from any source if they wish to include a pesticide in the list. The Committee will then review the information provided and may recommend the pesticide for listing.

The Conference of the Parties reviews the Committee’s recommendation and may take the final decision. It can also decide to remove a chemical from the Convention.

Imports

Each Party must specify whether or not it consents to the import into its territory of the hazardous chemicals or pesticides listed in the Convention. Parties may also decide to consent to import only subject to specified conditions. Interim decisions are also accepted. A Party that does not consent to the import of a chemical or that only consents under specified conditions must ensure that the import of the chemical from any source and the domestic production of the chemical for domestic use are made subject to the same conditions.

Exports

Each exporting Party must, of course, comply with the decisions of the other Parties relating to import authorisations. A chemical may not be exported to any Party that has failed to transmit a response or has transmitted an interim response. However, there are exceptions, for example where the importing Party has given its explicit consent to the import of the chemical in question.

In addition, the exporting Parties should assist importing Parties, upon request, to obtain further information and to strengthen their capacities to manage chemicals during their life-cycle.

Any exported chemical that is banned or severely restricted under the Convention must be accompanied by an export notification, and the importing Party must also acknowledge receipt of the chemical. The Convention contains provisions on the information that must accompany the chemicals, such as labelling requirements.

Exchange of information

The aim is to facilitate the exchange of scientific, technical, economic and legal information concerning the chemicals within the scope of the Convention, and to provide information on domestic regulatory actions in this area.

Technical assistance

Developing countries and countries with economies in transition may receive technical assistance from Parties which are more advanced in the area of chemical regulation.

Settlement of disputes

The Conference of the Parties draws up provisions on non-compliance with the Convention. With respect to dispute settlement, the Parties may resort to an arbitration procedure. A Party which is not a regional economic integration organisation may also submit the dispute to the International Court of Justice.

Withdrawal from the Convention

A Party may withdraw from the Convention three years after the date on which it came into force. This will take effect upon expiry of at least one year from the date of receipt of the notification of withdrawal.

REGULATION CONCERNING EXPORTS AND IMPORTS

The purpose of the Regulation is to implement the provisions of the Rotterdam Convention within the European Community. It will ensure that the measures laid down in the Convention are adopted; at the same time, some of the provisions contained in the Regulation will go beyond what is required in the Convention.

Chemicals concerned

The scope of the Regulation is wider than that of the Convention. It covers certain hazardous chemicals, which are banned or severely restricted within the Community or a Member State. It also covers the classification, packaging and labelling of all exported chemicals.

Export procedure

The Regulation establishes the deadlines and obligations which will apply to the notification procedure. The system requires that each exporter submit one export notification each year before the first export of a chemical. The notifications will be entered in a centralised register.

The Regulation contains certain measures that are more stringent than those of the Convention. Under the Regulation, any chemical or pesticide that is banned or severely restricted within the Community, and any articles containing these chemicals, must be accompanied by a notification. In addition, explicit consent for export is required for any dangerous chemical or pesticide which is banned or severely restricted within the Community, where it qualifies for PIC notification, even if that chemical or pesticide is not subject to the provisions of the Convention and is not included in the list of products already subject to the PIC procedure. The Regulation also imposes minimum standards concerning, for instance, the useful life of exported chemicals or pesticides, and storage conditions. The measures on labelling and packaging are also more stringent.

Export measures will apply to exports to all countries and not just to those that have signed the Convention.

The Regulation provides for the possibility of completely banning the export of certain specific chemicals or pesticides.

Penalties

The penalties applicable to infringements of the provisions of this Regulation is determined by the Member States. These must be effective, proportional and dissuasive.

Exchange of information

The provisions are extended to all countries and the Regulation refers to European Community participation in an information network on capacity building set up by the Intergovernmental Forum on Chemical Safety.

Monitoring and evaluation

The Regulation requires regular reports to be drawn up on the quantities of exported chemicals and pesticides concerned. As regards the monitoring and evaluation of the functioning of the Regulation, Member States must regularly submit information to the Commission, which in turn will draw up regular reports on the subject.

Implementation

The implementing conditions are mostly laid down by the Convention. Each Member States must designate one or several national authorities to ensure that the Regulation is implemented at national level. The European Commission will be responsible for implementation at Community level; it will also play a coordinating role between the Member States and between the European Community and the institutions of the Convention. The Commission will also be responsible for amending the annexes. It will be assisted by a committee.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Decision 2006/730/EC

19.2.2002

OJ L 299 of 28.10.2006

Regulation (EC) No 689/2008

1.8.2008

OJ L 204 of 31.7.2008

The successive amendments and corrections to Regulation (EC) No 689/2008 have been incorporated in the original text. This consolidated versionis of documentary value only.

International trade in hazardous chemicals

International trade in hazardous chemicals

Outline of the Community (European Union) legislation about International trade in hazardous chemicals

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Single Market for Goods > Chemical products

International trade in hazardous chemicals

Document or Iniciative

Regulation (EU) No. 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals.

Summary

The Regulation provides rules concerning the import of chemicals that are banned or severely restricted for use in the European Union (EU). Exporters shall be required to notify the export of chemicals subject to this Regulation before export can take place. Furthermore, the chemicals covered by the Rotterdam Convention, and chemicals that are banned or severely restricted in the European Union, cannot be exported without the consent of the importing countries.

This Regulation aims at ensuring that the provisions of the Regulation on the classification, labelling and packaging of chemical substances shall also apply to all chemicals when they are exported from Member States to other Parties to the Convention or to other countries, except if these provisions are incompatible with the specific requirements of these Parties or other countries.

Chemicals concerned:

This Regulation covers:

  • certain hazardous chemicals that are subject to the prior informed consent procedure (the ‘PIC procedure’) under the Rotterdam Convention;
  • certain hazardous chemicals that are banned or severely restricted within the Union or a Member State; and
  • all chemicals when exported in so far as their classification, labelling and packaging are concerned.

Certain products are excluded from the scope of the Regulation, specifically:

  • narcotic drugs and psychotropic substances;
  • radioactive materials;
  • wastes;
  • chemical weapons;
  • food and food additives;
  • feedingstuffs;
  • genetically modified organisms;
  • medicinal products;
  • chemicals exported for the purpose of research or analysis in low quantities which do not present a risk to health or the environment.

National authorities

Each Member State shall designate one or more authority to carry out the administrative functions required by this Regulation.

European Chemicals Agency

The European Chemicals Agency (ECHA) shall assist the Commission by managing the technical, scientific and administrative aspects relating to the import and export of said products. It shall send, in particular, manufacturers’ notifications to non-EU importing countries, manage all related communications, and maintain a database of the notifications which shall be accessible on its website.

Notification and explicit consent procedure

This Regulation sets the time periods and obligations concerning the notification procedure and the explicit consent procedure depending on the category to which the chemical product belongs.

Imports

The Commission shall adopt a decision in the form of a final or interim response regarding the import of the chemical in question. Where a chemical is subject to additional or amended restrictions, the Commission shall adopt a revised import decision.

In the case of a chemical being banned or severely restricted, the Commission shall take this information into account in its import decision.

Exports

Exporters must comply with the decisions of other Parties concerning import. Export of a chemical to a Party which has not provided a response concerning the import of the chemical concerned is prohibited. However, the chemical may be exported if the importing Party has given explicit consent for the chemical in question.

Any export of a chemical which is banned or severely restricted by European Union legislation must be notified to the importing country and said country must acknowledge receipt of the notification in accordance with the Convention.

Exchange of information

The Commission, assisted by ECHA and the Member States, shall facilitate the provision of scientific, technical, economic and legal information concerning the chemicals covered by this Regulation.

Technical assistance

The Commission, the designated national authorities of the Member States and ECHA shall cooperate in promoting technical assistance for the development of the infrastructure, the capacity and the expertise necessary to manage chemicals properly throughout their lifecycles, depending on the needs of developing countries and countries with economies in transition.

Penalties

The rules on penalties applicable to infringements of the provisions of this Regulation shall be determined by Member States. The penalties provided for must be effective, proportionate and dissuasive.

Repeal

This Regulation repeals Regulation (EC) No. 689/2008 with effect from 1 March 2014.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EU) No. 649/2012

16.8.2012

OJ L 201 of 27.7.2012

Chemical products

Chemical products

Outline of the Community (European Union) legislation about Chemical products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Single Market for Goods > Chemical products

Chemical products

The action undertaken by the European Community in the field of chemical products is part of an ongoing process launched a long time ago. The first Directive, which is concerned with the classification, packaging and labelling of dangerous substances, dates back to 1967. The REACH (Registration, Evaluation, Authorisation and Restrictions of Chemicals) Regulation, adopted at the end of 2006, establishes an enhanced framework which aims to guarantee the free movement of chemical products and the protection of human health and the environment.

DANGEROUS SUBSTANCES AND PREPARATIONS

  • Regulatory framework for the management of chemicals (REACH), European Chemicals Agency
  • Classification, packaging and labeling of chemicals and their mixtures
  • Classification, packaging and labelling of dangerous substances
  • Classification, packaging and labelling of dangerous preparations
  • International trade in hazardous chemicals
  • The Rotterdam Convention on the international trade in hazardous chemicals
  • Detergents
  • Community strategy for endocrine disrupters
  • Community strategy concerning mercury
  • Export and storage of mercury

PESTICIDES

  • Biocides
  • Biocides (until 1 September 2013)
  • Towards a thematic strategy on the sustainable use of pesticides

FERTILISERS

  • Fertilisers

CONTROL OF THE RISKS

  • Major accidents involving dangerous substances
  • The fight against bioterrorism (communication)
  • Good laboratory practice: tests on chemical substances
  • Good laboratory practice: inspection and verification of laboratory studies on all chemicals
  • Exposure to chemical agents

MANAGEMENT OF POLLUTANTS AND WASTE

  • Geneva Convention on Long-Range Transboundary Air Pollution
  • Stockholm Convention on persistent organic pollutants (POPs)
  • Controlled management of hazardous waste (until the end of 2010)
  • Basel Convention
  • Community strategy for dioxins, furans and PCBs
  • Disposal of polychlorinated biphenyls (PCBs) and polychlorinated terphenyls (PCTs)

Disposal of polychlorinated biphenyls

Disposal of polychlorinated biphenyls

Outline of the Community (European Union) legislation about Disposal of polychlorinated biphenyls

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Single Market for Goods > Chemical products

Disposal of polychlorinated biphenyls (PCBs) and polychlorinated terphenyls (PCTs)

Document or Iniciative

Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls [See amending act(s)].

Summary

Member States must take the necessary measures to ensure that:

  • used PCBs * are disposed of;
  • PCBs and equipment containing PCBs are decontaminated or disposed of.

Inventories must be compiled of equipment with PCB volumes of more than 5 dm3, which Member States must send to the Commission by September 1999 at the latest. The equipment and PCBs contained in the inventories must be decontaminated or disposed of by 2010 at the latest.

These inventories must supply the following data:

  • the names and addresses of the holders;
  • the location and description of the equipment;
  • the quantity of PCBs contained in the equipment;
  • the date and types of treatment planned;
  • the date of the declaration.

Any equipment which is subject to inventory must be labelled.

Member States must prohibit:

  • the separation of PCBs from other substances for the purposes of reusing the PCBs;
  • the topping-up of transformers with PCBs.

Member States must take the necessary measures to ensure that:

  • PCBs, used PCBs and equipment containing PCBs which is subject to inventory are transferred to licensed undertakings, at the same time ensuring that all necessary precautions are taken to avoid the risk of fire;
  • any incineration of PCBs or used PCBs on ships is prohibited;
  • all undertakings engaged in the decontamination and/or the disposal of PCBs, used PCBs and/or equipment containing PCBs obtain permits;
  • transformers containing more than 0.05% by weight of PCBs are decontaminated under the conditions specified by the Directive.

The Commission:

  • fixes the reference methods of measurement to determine the PCB content of contaminated materials;
  • sets the technical standards for the other methods of disposing of PCBs;
  • makes available a list of the production names of capacitors, resistors and inductance coils containing PCBs;
  • determines, if necessary, other less hazardous substitutes for PCBs.

Within the three years following the adoption of this Directive, Member States must draw up:

  • plans for the decontamination and/or disposal of inventoried equipment and the PCBs contained therein;
  • plans for the collection and subsequent disposal of equipment not subject to inventory.
Key terms of the Act
  • The acronym PCB means:
    • polychlorinated biphenyls,
    • polychlorinated terphenyls,
    • Monomethyl-tetrachlorodiphenyl methane, Monomethyl-dichloro-diphenyl methane, Monomethyl-dibromo-diphenyl methane,
    • any mixture containing any of the abovementioned substances in a total of more than 0,005 % by weight.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 96/59/EC

16.9.1996

16.3.1998

OJ L 243 of 24.9.1996

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 596/2009

7.8.2009

OJ L 188 of 18.7.2009

The successive amendments and corrections to Directive 96/59/EC have been incorporated in the original text. This consolidated version is of documentary value only.

Related Acts

Decision 2001/68/EC of the Commission of 16 January 2001 establishing two reference methods of measurement for PCBs pursuant to Article 10(a) of Council Directive 96/59/EC on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCBs/PCTs) [Official Journal L 23 of 25.01 2001].