Category Archives: 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.

Internal Market

Internal Market

Internal Market Contents

  • Internal market: general framework
  • Living and working in the internal market: Free movement of people, asylum and immigration, free movement of workers
  • Single Market for Goods: Free movement of goods, technical harmonisation, product labelling and packaging, consumer safety, pharmaceutical and cosmetic products, chemical products, motor vehicles, construction, external dimension
  • Single market for services: Free movement of services, professional occupations, services of general interest, transport, Information Society, postal services, financial services, banks, insurance, securities markets
  • Single market for capital: Free movement of capital, economic and monetary union, economic and private stakeholders, fiscal aspects, combating fraud, external relations
  • Businesses in the internal market: Company law, public procurement, intellectual property

See also

Living and working in the internal market.
Overviews of European Union: Internal market.
Further information: the Internal Market and Services Directorate-General of the European Commission.

Community strategy for endocrine disrupters

Community strategy for endocrine disrupters

Outline of the Community (European Union) legislation about Community strategy for endocrine disrupters

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

Community strategy for endocrine disrupters

The Commission has developed a strategy to deal urgently with the problem of endocrine disrupters which damage health and the environment.

Document or Iniciative

Communication from the Commission to the Council and the European Parliament of 17 December on a Community strategy for endocrine disrupters [COM(1999) 706 final – Not published in the Official Journal].

Summary

Context
The phenomenon of endocrine disrupters is not new. Recently, however, it has attracted significant media attention and has become a cause for public concern. Some Member States have already introduced measures to limit or prohibit certain suspected substances. Though considerable research still needs to be carried out in this area, growing public concern and the various research results already available confirming the problems linked to these substances have prompted the Community to act urgently to address the problem.

Definition
The endocrine system consists of a set of glands and the hormones they produce, which help guide the development, growth, reproduction and behaviour of animals, including human beings. Endocrine disrupters are agents which appear to interfere with (or “disrupt”) the functioning of this system.

Natural hormones, synthetically produced hormones and some man-made chemicals are capable of disrupting the endocrine system. The adverse effects of endocrine disrupters on health and the environment appear to relate in particular to exposure to synthetically produced hormones and man-made chemicals. Amongst other things, they impair reproduction and development and cause certain cancers. Cases of impaired reproduction are well documented in a number of species. For instance, the masculinisation of female marine snails has been observed. Endocrine disruption is also particularly marked in wildlife.

Strategy
Existing legislation does not necessarily take account of the adverse effects of endocrine disrupters. In this communication, the Commission proposes a strategy comprising short, medium and long-term action to tackle the problem. It should be noted that much research remains to be done in this area and that there is still no validated test method for establishing definitively whether a substance actually is an endocrine disrupter. The strategy is thus based on existing information but should be flexible enough to incorporate new scientific knowledge.

Similarly, the measures are based on an assessment of the likely timeframe within which results can be achieved, i.e. 1-2 years for short-term actions, 2-4 years for medium-term actions and more than 4 years for long-term action.

Shortterm measures

  • Establishment of a priority list for evaluation.
    This is a list of substances requiring priority evaluation (“ED priority list”) to identify inter alia substances which can already be addressed under existing legislation, gaps in knowledge and specific cases of consumer use for special consideration;
  • Use of existing legislative instruments.
    Though the amendment of legislation is a long-term action, efforts can be made to reinforce or speed up the implementation of existing legislation such as the Regulation on risk assessment and the Directive on the classification of dangerous substances;
  • Establishment of monitoring programmes.
    The programmes should give an estimation of exposure to the substances on the ED priority list, so that their impact may be studied in terms of dose, timing of exposure, etc.;
  • Identification of specific cases.
    Identifying vulnerable groups exposed to certain substances (e.g. children) and, where those substances are not covered by the existing legislation, examining whether they need to be entered on the ED priority list;
  • Exchange of information and effective coordination between players.
    (Commission, Member States, industry, etc., and at international level);
  • Full public information.
    Informing the public about what is being done, explaining the mechanisms and making information such as the ED priority list public;
  • Regular consultation of stakeholders.
    (Governments, NGOs, industry, etc.).

Mediumterm measures

  • Identification and assessment of endocrine disrupters.
    Pursuing international cooperation on research to establish validated test methods capable of identifying endocrine disrupters;
  • Further research and development.

    Particularly through the fifth framework programme of research and development;
  • Encouragement of research into substitutes and voluntary initiatives.

Longterm measures

  • Adaptation/amendment of current legislation to take account of ED.
    In particular Regulation (EEC) No 793/93 on risk assessment and Directive 67/548/EEC on the classification of dangerous substances.

It must also be ensured that other measures, such as legislation to protect the environment (e.g. the water framework Directive) or consumers, take account of endocrine disruption.

Related Acts

Communication from the Commission to the Council and the European Parliament of 14 June 2001 on the implementation of the Community Strategy for Endocrine Disrupters [COM(2001) 262 final Not yet published]
This communication is the first report on the implementation of the strategy for endocrine disrupters. It examines the progress which has been made and sets out future action.

Regarding short-term measures, in 2000 a priority list was compiled of 553 man-made substances and 9 synthetic/natural hormones. A list was also compiled of priority actions to evaluate the role of these substances. The Commission also organised a workshop on endocrine disrupters from 18 to 20 June 2001 in Sweden.

The Commission is continuing to participate in the OECD Endocrine Disrupter Testing and Assessment Task Force, whose goal is to develop agreed test methods for endocrine disrupters. The latest estimates are that agreed test methods for human health should be available in 2002, with tests for environmental effects expected between 2003 and 2005.

Research into endocrine disruption is a priority of the 5th Community framework programme of research and development. A dedicated call for research proposals was published in May 2001 and an overall budget of 20 million euros has been provided.

Regarding legislative action, the proposed revision of the General Product Safety Directive includes inter alia a simplification of conditions and procedures for urgent measures at Community level. In addition, the issue of endocrine disrupters is addressed specifically in the context of new (the water framework Directive) and existing legislation and in the White Paper on a strategy for a future chemicals policy.

Following the preparatory activities carried out in 2000, the year 2001 will be dedicated to detailed evaluation of substances. In 2001-2002, priority will also be given to collecting data, launching research projects and encouraging Member States to speed up the current risk assessment process for existing substances under existing legislation.

 

Fertilisers

Fertilisers

Outline of the Community (European Union) legislation about Fertilisers

Topics

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

Agriculture > Environment

Fertilisers

Document or Iniciative

Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers [See Amending Act(s)].

Summary

The European Union (EU) gathers all rules applying to fertilisers into a single piece of legislation in order to ensure the uniform application of a package of very technical provisions.

EC fertilisers

This Regulation only applies to mineral fertilisers made up of one or more plant nutrients (or fertilising elements).

All types of fertiliser in Annex I which comply with the provisions of this regulation may bear the words “EC fertiliser”. The list of the various types of fertilisers authorised on the European market may be extended. In order to be listed, the manufacturer must apply to the competent authority in their country and constitute a technical file on the characteristics of the fertiliser. Applications are then sent to the Commission, which accepts or rejects the manufacturer’s application.

All fertilisers bearing the words “EC fertiliser” may circulate freely on the European market. Member States may not prohibit or limit their placing on the market unless they consider that the fertiliser in question represents a danger for health or a risk to the environment. In such cases, the product is temporarily withdrawn from the market until a study is carried out at European level to ascertain whether the risk is well founded.

Legal requirements

A type of fertiliser shall only bear the words “EC fertiliser” if:

  • it has no adverse effect on the health of humans, animals, plants or the environment under normal conditions of use;
  • it is effective;
  • relevant sampling and analysis methods are being provided.

Annex I of the Regulation also establishes minimum nutrient content required for each type of fertiliser (nitrogen content, phosphorus content, etc.).

The Regulation lays down a certain number of compulsory statements which must appear on the packaging and labels of fertilisers. In particular, these include the marking “EC fertiliser”, details relating to the description of nutrients or micro-nutrients, information about the manufacturer and, if applicable, details of blends. Some optional information is also recommended, such as specific directions for the use, storage and handling of the fertiliser.

The Regulation harmonises the rules on labelling and packaging in the EU. These rules concern, inter alia, the marking of nutrient content. Quantities of substances may be indicated in several ways. For example, phosphate content may be indicated in elemental form or in oxide form.

Provisions for specific types of fertilisers

The Regulation sets out detailed technical provisions regarding the scope, declaration, identification and packaging of four types of fertiliser:

  • main inorganic nutrient fertilisers: these are the main fertilising elements supplied in substantial quantities for plant growth, i.e. nitrogen, phosphorus and potassium;
  • secondary inorganic nutrient fertilisers: these are calcium, magnesium, sodium and sulphur;
  • inorganic micro-nutrient fertilisers: these contain elements required in small quantities such as boron, cobalt, copper, iron, manganese, etc.;
  • ammonium nitrate fertilisers of high nitrogen content: given the dangerous nature of this type of fertiliser, the Regulation lays down additional measures such as a detonability test described in Annex III to this Regulation.

Controls

Member States may carry out official controls to verify compliance of fertilisers bearing the words “EC fertiliser” with the provisions of the Regulation. These control measures are to be carried out by designated laboratories in each Member State in accordance with a uniform procedure set out in the Annexes to the Regulation.

For inspection purposes, manufacturers must keep records of the origin of “EC fertilisers” for as long as they are being supplied to the market.

Member States determine the rules on penalties applicable to infringements of the provisions of the Regulation.

Implementation at Community level

The Commission shall be assisted in implementing the Regulation and making adaptations to the Annexes by a committee composed of representatives of the Member States.

References

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

Regulation (EC) No 2003/2003

11.12.2003
(11.6.2005 for Articles 8 and 26)

OJ L 304, 21.11.2003

DEROGATIONS FROM THE ACT

Decision 2006/348/EC [Official Journal L 129 of 17.5.2006].
This derogation applies to the maximum admissible content of cadmium in fertilisers notified by the Republic of Finland.

Decision 2006/349/EC [Official Journal L 129 of 17.5.2006].
This derogation applies to the maximum admissible content of cadmium in fertilisers notified by the Republic of Austria.

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

Successive amendments and corrections to Regulation (EC) No 2003/2003 have been incorporated into the basic text. This consolidated versionis for information only.


Another Normative about Fertilisers

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

Fertilisers

Document or Iniciative

Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers [See Amending Act(s)].

Summary

The European Union (EU) gathers all rules applying to fertilisers into a single piece of legislation in order to ensure the uniform application of a package of very technical provisions.

EC fertilisers

This Regulation only applies to mineral fertilisers made up of one or more plant nutrients (or fertilising elements).

All types of fertiliser in Annex I which comply with the provisions of this regulation may bear the words “EC fertiliser”. The list of the various types of fertilisers authorised on the European market may be extended. In order to be listed, the manufacturer must apply to the competent authority in their country and constitute a technical file on the characteristics of the fertiliser. Applications are then sent to the Commission, which accepts or rejects the manufacturer’s application.

All fertilisers bearing the words “EC fertiliser” may circulate freely on the European market. Member States may not prohibit or limit their placing on the market unless they consider that the fertiliser in question represents a danger for health or a risk to the environment. In such cases, the product is temporarily withdrawn from the market until a study is carried out at European level to ascertain whether the risk is well founded.

Legal requirements

A type of fertiliser shall only bear the words “EC fertiliser” if:

  • it has no adverse effect on the health of humans, animals, plants or the environment under normal conditions of use;
  • it is effective;
  • relevant sampling and analysis methods are being provided.

Annex I of the Regulation also establishes minimum nutrient content required for each type of fertiliser (nitrogen content, phosphorus content, etc.).

The Regulation lays down a certain number of compulsory statements which must appear on the packaging and labels of fertilisers. In particular, these include the marking “EC fertiliser”, details relating to the description of nutrients or micro-nutrients, information about the manufacturer and, if applicable, details of blends. Some optional information is also recommended, such as specific directions for the use, storage and handling of the fertiliser.

The Regulation harmonises the rules on labelling and packaging in the EU. These rules concern, inter alia, the marking of nutrient content. Quantities of substances may be indicated in several ways. For example, phosphate content may be indicated in elemental form or in oxide form.

Provisions for specific types of fertilisers

The Regulation sets out detailed technical provisions regarding the scope, declaration, identification and packaging of four types of fertiliser:

  • main inorganic nutrient fertilisers: these are the main fertilising elements supplied in substantial quantities for plant growth, i.e. nitrogen, phosphorus and potassium;
  • secondary inorganic nutrient fertilisers: these are calcium, magnesium, sodium and sulphur;
  • inorganic micro-nutrient fertilisers: these contain elements required in small quantities such as boron, cobalt, copper, iron, manganese, etc.;
  • ammonium nitrate fertilisers of high nitrogen content: given the dangerous nature of this type of fertiliser, the Regulation lays down additional measures such as a detonability test described in Annex III to this Regulation.

Controls

Member States may carry out official controls to verify compliance of fertilisers bearing the words “EC fertiliser” with the provisions of the Regulation. These control measures are to be carried out by designated laboratories in each Member State in accordance with a uniform procedure set out in the Annexes to the Regulation.

For inspection purposes, manufacturers must keep records of the origin of “EC fertilisers” for as long as they are being supplied to the market.

Member States determine the rules on penalties applicable to infringements of the provisions of the Regulation.

Implementation at Community level

The Commission shall be assisted in implementing the Regulation and making adaptations to the Annexes by a committee composed of representatives of the Member States.

References

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

Regulation (EC) No 2003/2003

11.12.2003
(11.6.2005 for Articles 8 and 26)

OJ L 304, 21.11.2003

DEROGATIONS FROM THE ACT

Decision 2006/348/EC [Official Journal L 129 of 17.5.2006].
This derogation applies to the maximum admissible content of cadmium in fertilisers notified by the Republic of Finland.

Decision 2006/349/EC [Official Journal L 129 of 17.5.2006].
This derogation applies to the maximum admissible content of cadmium in fertilisers notified by the Republic of Austria.

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

Successive amendments and corrections to Regulation (EC) No 2003/2003 have been incorporated into the basic text. This consolidated version is for information only.

Detergents

Detergents

Outline of the Community (European Union) legislation about Detergents

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

Detergents

Document or Iniciative

Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents [See amending acts].

Summary

Protection of the environment

This Regulation permits improved protection of the aquatic environment against the surfactants in detergents and other cleaning products. These surfactants – also called tensides – are included in detergents and other cleaning products in order to reduce the surface tension of liquids so that they can wet surfaces and clean them more effectively. The legislation has been made more restrictive by including all types of surfactants and imposing stricter testing methods for detergents to determine the ultimate rather than the initial biodegradability.

Protection of consumers

Consumers will be better protected against fragrance substances and preservation agents that are present in detergents and can cause allergies. Specific labelling has been introduced to inform consumers about the presence in detergents of this type of substance. The Regulation makes the provisions of Commission Recommendation 89/542 on the labelling of these allergenic substances compulsory, by incorporating them into the new legislation.

For healthcare professionals it is possible to obtain from manufacturers full listings of the ingredients in detergents so that they can determine whether there is a causal link between a patient’s allergy and a product which is present in a detergent.

Labelling

Manufacturers must list on the labelling all components in decreasing order of concentration as well as the address of a website where consumers can obtain the complete list of ingredients.

All allergens must be indicated on the label.

This Regulation also adds an additional testing method for surfactants with limited solubility in water (amendment to Annex III). This method complies with the standard ISO 10708: 1997 “Water quality – Evaluation in an aqueous medium of the ultimate aerobic biodegradability of organic compounds”.

The legislation on detergents henceforth applies to all types of surfactant detergents, including fabric softeners and washing machine products.

Context

This Regulation expands the scope of the existing legislation. It repeals five directives on biodegradable surfactant detergents (Directives 73/404/EEC, 73/405/EEC, 82/242/EEC, 82/243/EEC and 86/94/EEC) and Commission Recommendation 89/542 on the labelling of detergents.

This Regulation aims to harmonise the regulations in Member States in a uniform and simultaneous manner and to simplify future changes.

References

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

Regulation (EC) No 648/2004

08.10.2005

08.10.2005

OJ L 104 of 08.04.2004; corrigendum OJ L 328 of 15.12.2005.

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

Regulation (EC) No 1336/2008

20.1.2009
1.6.2015 (Art. 1, points 2 and 3)

OJ L 354 of 31.12.2008

Regulation (EC) No 219/2009

20.4.2009

OJ L 87 of 31.3.2009

The successive amendments and corrections to Regulation (EC) No 648/2004 have been incorporated into the original text.

AMENDMENTS TO THE ANNEXES

Annex III – Biodegradability control methods

Regulation (EC) No 907/2006 [Official Journal L 168 of 21.6.2006].

Annex V – List of surfactant derogations

Regulation (EC) No 551/2009 [Official Journal L 164 of 26.6.2009].

Annex VI – List of surfactants whose use in detergents is prohibited or restricted

Regulation (EC) No 551/2009 [Official Journal L 164 of 26.6.2009].

Annex VII – Labelling and information sheets on ingredients

Regulation (EC) No 907/2006 [Official Journal L 168 of 21.6.2006].

Related Acts

Report from the Commission to the European Parliament and the Council pursuant to Article 16 of Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents, concerning anaerobic biodegradation [COM(2009) 230 final – Not published in the Official Journal].

The Commission states in the Report that, in contrast to the absence of aerobic degradation, the lack of anaerobic degradation of surfactants does not seem to be correlated with any apparent risk for the environment. Anaerobic biodegradability should therefore not be used to determine the eventual environmental acceptability of surfactants such as linear alkylbenzene sulphonate (LAS), which are readily biodegradable under aerobic conditions.
As a result, the possible environmental toxicity of surfactants focuses on their biodegradability.
Information provided under the REACH registration procedure should enable the toxicity or absence of toxicity for health and the environment of the ingredients in detergents to be determined. This information should be sufficient to decide whether restrictions on certain surfactants in detergents formulations are needed in addition to those already imposed by the Detergents Regulation.

Report from the Commission to the European Parliament and the Council Pursuant to Article 16 of Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents, concerning the biodegradation of main non-surfactant organic detergent ingredients [COM(2009) 208 final – Not published in the Official Journal].

When the Detergents Regulation was adopted in 2004, the criterion of ultimate biodegradability ensured that detergent surfactants did not pose a risk to the environment. In the meantime, significant efforts have been made, particularly in preparation for the REACH programme, with the aim of carrying out targeted risk assessments on detergent ingredients. No risk to the environment has been identified for any of the non-surfactant organic detergent ingredients. Many of the non-surfactant organic ingredients are not ultimately biodegradable and are neither toxic to human health nor to the environment. It is, therefore, not considered appropriate to impose a requirement of ultimate biodegradability on the non-surfactant organic ingredients in Community legislation. Applying a principle of ultimate biodegradability to the nonsurfactant organic ingredients would lead to the banning of a number of them where it is known that they do not pose risks. It would therefore be more proportionate to complete instead the risk assessments on the few outstanding substances. The information to be provided in the registration dossiers detailed in the REACH Regulation should enable the environmental risk of toxicity of these substances to be assessed. The REACH registration information should be sufficient to decide whether restrictions on the above-mentioned detergent organic ingredients are needed.

Report from the Commission to the Council and the European Parliament Pursuant to Article 16 of Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents, concerning the use of phosphates [COM(2007) 234 final – Not published in the Official Journal].
The Commission reviewed the progress made in establishing whether legislative measures are justified for regulating the use of phosphates in detergents, in order to improve the quality of bodies of water, which are threatened by an accelerated growth of algae (eutrophication) due to the enrichment of water by nutrients.
An impact assessment of phosphates on eutrophication has been carried out at a pan-European level to evaluate the advantages of switching from phosphate-based detergents to other alternatives. The results of the assessment were still being evaluated by the Commission Scientific Committee at the time of the Report.

Classification, packaging and labelling of dangerous preparations

Classification, packaging and labelling of dangerous preparations

Outline of the Community (European Union) legislation about Classification, packaging and labelling of dangerous preparations

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

Classification, packaging and labelling of dangerous preparations

Document or Iniciative

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [See amending acts].

Summary

Scope

This Directive applies to dangerous preparations which contain at least one dangerous substance within the meaning of Article 2 or which are considered dangerous within the meaning of Articles 5, 6 or 7. The term “preparation” covers mixtures or solutions composed of two or more substances.

This Directive provides specific provisions for preparations which are not considered dangerous (within the meaning of Articles 5, 6 or 7), but which may nevertheless present a specific hazard.

This Directive shall not apply to the following preparations in the finished state, intended for the final user:

  • medicinal products for human or veterinary use;
  • cosmetic products;
  • mixtures of substances in the form of waste covered by Directive 2006/12/EC on waste disposal);
  • foodstuffs;
  • animal feedingstuffs;
  • preparations containing radioactive substances;
  • medical devices which are invasive or used in direct physical contact with the human body;
  • the carriage of dangerous preparations by rail, road, inland waterway, sea or air;
  • ,preparations in transit which are under customs supervision, provided they do not undergo any treatment or processing.

Classification

The classification of dangerous preparations shall be based on the definitions of categories of danger laid down in Article 2 of the Directive. These categories take into account the degree and specific nature of the hazards involved. They include preparations considered dangerous due to:

  • physico-chemical properties (for example, explosive, oxidising, or flammable); and/or
  • the health hazards it presents (for example, toxic, carcinogenic or harmful); and/or
  • the environmental hazards it presents.

The general principles of classification and labelling of dangerous substances applies to the methods specified in Regulation (EC) No 440/2008 and the criteria laid down in Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances, save where alternative criteria in the Directive are applied.

Packaging

The main requirements relating to packaging are as follows:

  • it shall be so designed and constructed that its contents cannot escape;
  • the materials constituting the packaging and fastenings must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents;
  • packaging and fastenings must be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;
  • the shape and/or graphic decoration of packaging shall not arouse the curiosity of children nor mislead consumers;
  • it shall be designed so that it cannot be confused with foodstuffs, animal feedingstuffs, medicinal products or cosmetics;
  • containers for preparations must be fitted with child-resistant fastenings and/or carrying a tactile warning of danger.

Labelling

Any package must be clearly and indelibly marked with certain specific information such as:

  • the trade name of the preparation;
  • the name and contact details of the person responsible for placing it on the market;
  • in general the chemical name of the substance or substances present in the preparation which have given rise to the classification of the preparation with regard to health hazards;
  • the danger symbols and indications of danger, the risk phrases and the safety advice. Specific provisions concerning the presentation, format and wording of this information are laid down in Annexes II and VI to the Directive 67/548/EEC.

Member States may require the labelling of a preparation to be produced in their official language(s).

Under certain very restricted conditions specified in Article 12 of the Directive, some dangerous preparations may be exempt from the general requirements on packaging and labelling. Henceforth, the labelling of these preparations may be optional or may differ from the requirements laid down if the quantities present are so low that they do not present any hazard to users.

Obligations and duties of the Member States

The Member States appoint a national authority who shall inform the Commission on the application of this Directive. Those responsible for placing dangerous preparations on the market must hold at the disposal of that authority all information relating to the classification of the preparation (safety data, etc.).

Member States are required to designate the bodies responsible for receiving information on the health effects of preparations. This information can be used only in response to requests of a medical nature.

Confidentiality

The person responsible for placing a dangerous preparation on the market may make a request for confidentiality. This request is addressed to the competent authority of the Member States in which the preparation is to be first placed on the market. This procedure prevents the disclosure of the chemical identity of a certain substance on the label and does not risk the confidential nature of intellectual property. When the authority has made its decision, it shall inform the person responsible for placing the preparation on the market.

Free movement clause

Member States may not prohibit, restrict or impede the placing on the market of dangerous preparations which satisfy the requirements of this Directive.

Safeguard clause

A Member State may provisionally prohibit the placing on the market of a dangerous preparation or subject it to special conditions in its territory, even if it complies with the provisions of this Directive.

The Member States shall inform the Commission and the other Member States immediately of the adoption of such a measure and the reasons for its decision. The Commission shall consult Member States as soon as possible before making its decision.

Procedure for adaptation to technical progress

The amendments required to adapt the nine annexes to technical progress are adopted by the Commission with the assistance of a regulatory committee made up of representatives of the Member States and chaired by a representative of the Commission.

Context

This Directive shall be repealed with effect on 1 June 2015 by Regulation (EC) No 1272/2008 on the classification, labelling and packaging of chemicals and their mixtures.

References

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

Directive 1999/45/EC

30.7.1999

30.7.2002

O.J. L 200 of 30.7.1999

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

Regulation (EC) No 1907/2006

1.6.2007
Application:
1.6.2008
1.8.2008 (Art. 135)
1.6.2009 (Title VIII and Annex XVII)

OJ L 396 of 30.12.2006

Regulation (EC) No 1137/2008

11.12.2008

OJ L 311 of 21.11.2008

Regulation (EC) No 1272/2008

20.1.2009

OJ L 353 of 31.12.2008

The successive amendments and corrections to Directive 1999/45/EC have been incorporated in the original text. This consolidated version is of documentary value only.

Classification, packaging and labelling of dangerous substances

Classification, packaging and labelling of dangerous substances

Outline of the Community (European Union) legislation about Classification, packaging and labelling of dangerous substances

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

Classification, packaging and labelling of dangerous substances

Document or Iniciative

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [See amending acts].

Summary

This is the first harmonising Directive in the field of chemical products. Given the extent of that field, the Commission limited the scope of this first Directive to the harmonisation of the classification, packaging and labelling of dangerous substances.

The Directive does not affect provisions relating to:

  • medicinal products;
  • cosmetic products;
  • mixtures of substances in the form of waste;
  • food;
  • animal feed;
  • pesticides;
  • radioactive substances;
  • other substances or preparations for which notification or approval procedures exist;
  • the carriage of dangerous substances;
  • unrefined substances which are in transit and are subject to customs inspection.

Definition

Within the meaning of the Directive, the term “substances” means chemical elements and their compounds as they occur in the natural state or as produced by industry. “Preparation” refers to mixtures or solutions composed of two or more substances.

Classification

The classification of dangerous substances is based on categories clearly defined in the Directive according to the greatest degree of hazard and the specific nature of the risks. These categories include explosive substances, inflammable substances, toxic substances, harmful substances, etc.

The Annexes to the Directive contain, among other things, a list of dangerous substances (Annex I), their classification and the provisions for their labelling, the symbols relating to each substance, the standard phrases relating to the nature of the special risks of each substance as well as, if the case arises, any phrases giving advice on safety precautions for the substance.

Packaging

The packaging of substances must comply with the following provisions:

  • the packaging must prevent any loss of the contents, except where special safety devices are prescribed;
  • the materials constituting the packaging and fastenings must not be liable to attack by the contents or liable to form harmful or dangerous compounds with the contents;
  • packaging and fastenings must be resistant and solid.

Labelling

The labelling must indicate:

  • the name of the substance;
  • the origin of the substance (name and address of the manufacturer, distributor or importer);
  • danger symbols and indication of danger involved in the use of the substance;
  • a reference to the special risks arising from such dangers.

This information must be presented in accordance with the Annexes to the Directive (symbols, standard phrases, etc.). The same applies to any advice on safety precautions.

The labelling must, in addition, comply with provisions on the size of the labelling. In particular, the dimensions of the label must not be less than those of a standard A8 sheet (52 x 74 mm), and each symbol must cover at least one tenth of the surface area of the label.

Member States may require their national language or languages to be used in the labelling of dangerous substances.

Where the packaging is too small, the labelling may be affixed in some other manner.

Member States may allow dangerous substances which are not toxic or explosive to derogate from the general rules on labelling established in Articles 23 and 24 of this Directive. The labelling of these substances may therefore be optional or differ from the established rules if they are present in such small quantities that there is no danger to users,

In the context of the international and/or national transport of dangerous substances, the labelling must comply with the international and/or national rules. Member States may not hamper the free movement within the European Community of dangerous substances which comply with the Directive, unless they establish that the substance constitutes a hazard to health and/or the environment. In such a case, the Member State must inform the Commission, which must launch a consultation procedure to assess the hazards and take any other necessary action

Member States must inform the Commission of measures taken pursuant to the Directive.

Context

Annex I is removed by Regulation (EC) No 1272/2008 on the classification, packaging and labelling of chemicals and their mixtures and replaced by Table 3.1 of Annex VI to this Regulation from 20 January 2009.

Annex II will be repealed on 1 June 2015.

Annex III will be repealed on 1 June 2015.

Annex IV will be repealed on 1 June 2015.

Annex V is replaced by Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation

(EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) with effect from 1 June 2008.

Annex VI will be repealed on 1 June 2015. However, the provisions on the labelling and packaging of substances in Annex VI will no longer apply with effect from 1 December 2010.

Annex VII A, VII B, VII C, VII D and Annex VIII are deleted by Directive 2006/121/EC with effect from 1 June 2008.

Annex IX will be repealed with effect from 1 June 2015.

This Directive will be repealed in its entirety on 1 June 2015.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 67/548/EEC

29.6.1967

1.1.1970

1.1.1975 (Ireland)

OJ P 196 of 16.8.1967

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

Directive 71/144/EEC

24.3.1971

OJ L 74 of 29.3.1971

Directive 73/146/EEC

24.5.1973

24.11.1973

OJ L 167 of 25.6.1973

Directive 75/409/EEC

27.6.1975

1.6.1976

OJ L 183 of 14.7.1975

Directive 79/831/EEC

19.7.1976

18.9.1981
 Specific measures for the articles in the market before this date
18.9.1983
 deadline for the remaining articles

OJ L 259 of 15.10.1979

Directive 92/32/EEC

22.5.1992

31.10.1993

OJ L 154 of 5.6.1992

Directive 96/56/EC

21.9.1996

1.6.1998

OJ L 236 of 18.9.1996

Directive 1999/33/EC

19.8.1999

30.7.2000

OJ L 199 of 30.7.1999

Regulation (EC) No 807/2003

5.6.2003

OJ L 122 of 16.5.2003

Directive 2006/121/EC

19.1.2007

1.6.2007

OJ L 396 of 30.12.2006

Regulation (EC) 1272/2008

20.1.2009

OJ L 353 of 30.12.2008

The fight against bioterrorism

The fight against bioterrorism

Outline of the Community (European Union) legislation about The fight against bioterrorism

Topics

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

Public health > Threats to health

The fight against bioterrorism (communication)

Document or Iniciative

Communication from the Commission of 2 June 2003 to the Council and the European Parliament on cooperation in the European Union on preparedness and response to Biological and Chemical agent attacks (Health security) [COM(2003) 320 final – Not published in the Official Journal].

Summary

This Communication is a follow-up to the unprecedented terrorist attacks in the USA in September 2001. Governments and international bodies responded to this event by examining the means they had at their disposal to prevent and counter threats and mitigate the effects of such attacks. They also undertook to develop appropriate responses to a new type of threat, that of deliberate releases of biological and chemical agents.

This Communication reports on the health aspects of European Union (EU) action against bioterrorism and reviews the measures taken to strengthen health defences against deliberate releases of biological and chemical agents. It also highlights the challenges facing the health sector in terms of preparedness and response.

RECENT BIOTERRORIST INCIDENTS AND REPERCUSSIONS IN THE EU

Shortly after the attacks of 11 September, the US was hit by a spate of bioterrorist incidents involving anthrax spores. These terrorist acts had a significant impact in Europe. Civil protection and security forces were put on alert, and public health systems had to deal with numerous items of mail containing powders suspected of being contaminated with anthrax. Although no bioterrorist attack was known to have taken place in Europe, the pressure on European countries was high, as they quickly had to devote resources to preventing a new type of threat. In January 2003, the discovery of ricin — a potentially fatal toxic substance — in a building in London served as a sharp reminder to emergency health services to intensify their efforts in the fight against bioterrorism.

The international community and the EU responded to this new threat by adopting the following measures:

  • conclusions of the Health Council of 15 November 2001: the Belgian Presidency adopted conclusions which called on the Commission to develop an action programme of cooperation on preparedness and response to biological and chemical agent threats;
  • Ottawa initiative: a meeting held in Ottawa on 7 November 2001 brought together the Health Ministers from the G7 group of countries, the Health Minister of Mexico and the Member of the Commission responsible for Health and Consumer Protection. The meeting agreed on concerted global action to strengthen the public health response to the threat of international biological, chemical and radio-nuclear terrorism;
  • Commission response: the Commission launched a series of coordinated actions across the civil protection, health, enterprise (pharmaceuticals), research, nuclear and transport and energy fields. These were reported in the communication on ” Civil protection: state of preventive alert against possible emergencies ” published in November 2001.
    On 20 December 2002, the Council and the Commission also adopted a joint programme to improve cooperation between Member States in the evaluation of Chemical, Biological and Radio-Nuclear (CBRN) risks, alerts and intervention, the storage of means of intervention and in the field of research.

PUBLIC HEALTH PREPAREDNESS AND RESPONSE

Preparedness

Mitigating the effects of deliberate releases of biological and chemical agents requires early detection of the agents implicated and case recognition of those affected. Health authorities and agencies have a crucial role here and must:

  • establish effective surveillance;
  • familiarise clinicians with the syndromes to look out for;
  • disseminate case management guidelines;
  • put in place effective arrangements for prompt notifications to the authorities in charge of collecting and evaluating epidemiological information;
  • coordinate public health responses.

The necessary laboratory expertise and capacity must be available to cope with high-risk agents and complex technology as well as a surge in demand in case of multiple attacks.

Response

In the event of an attack, measures for physical protection and assistance must be able to be taken immediately and an initial assessment made of consequences and risks so that appropriate action can be initiated forthwith. The health authorities are responsible for taking preventive, remedial and treatment action (decontaminating exposed persons, taking swabs for analysis, administering prophylactic treatments, etc.). In addition, emergency plans provide a high degree of confidence in the capacity to mount an effective multi-sector response. The means of response and the deployment capability of health response staff must be strengthened in order to optimise their ability to cope in the event of an attack.

Coordination in the EU

The EU is a border-free area, so it is essential for appropriate arrangements to be put in place to ensure prompt notification and exchange of information in the event of threats and attacks. The importance of joint action in the EU led to the establishment in October 2001 of a Health Security Committee, comprised of representatives of the Health Ministers, to promote cooperation in countering bioterrorism. The Committee agreed a programme of cooperation on preparedness and response to biological and chemical agent attacks, code-named BICHAT, based on four objectives:

  • To set up an alert and information exchange mechanism
    This mechanism consists of a Health Security Committee and a rapid alert system. The Health Security Committee is responsible for exchanging information on health-related threats, on preparedness and response plans and crisis management strategies. The rapid alert system (code-named “RAS-BICHAT”) has been in operation since June 2002 for notifications of incidents involving the deliberate release of biological and chemical agents to cause harm;
  • To create a capability for the detection and identification of biological and chemical agents that might be used in attacks.
    Detection of deliberate releases of biological agents relies first and foremost on Member States’ surveillance systems for monitoring the occurrence of infectious diseases. It is essential that Member States continue to develop new diagnostics for rapid detection. Coordination of these surveillance systems at EU level is conducted in line with a Decision of September 1998 on the surveillance and control of communicable diseases.
    Biological agents likely to be used in bioterrorism have already been prioritised on the basis of various criteria. In addition, a Council Regulation (No 1334/2000) lays down various lists of biological and chemical agents for which provisions linked to export control arrangements apply.
    Laboratory capacity continues to be insufficient in many Member States. It is therefore imperative that Member States share resources and that those with advanced facilities assist those without;
  • To create a database on medicines stock and health services (see next section) and a stand-by facility for making medicines and health care specialists available in case of attack;
  • To draw up rules and disseminate guidance on responding to attacks from the health point of view and coordinating the EU response and links with third countries and international organisations. Consultations in the EU and internationally showed that the process of adjusting national emergency plans to the new threat of covert release of chemical and biological agents was not yet complete in the Member States. Moreover, it is a priority to intensify work on emergency planning and promote modelling in order to reinforce emergency plans for threats and attacks.

In February 2007, the Council extended the mandate of this Health Security Committee by three years.

AVAILABILITY AND STOCKPILING OF MEDICINES

The bioterrorist attacks in the USA highlighted the fundamental importance of the availability of medicines in the EU and the capability of industry to make good any shortcoming in production and supply. A joint Commission/pharmaceutical industry task force was established in December 2001 to address issues of availability, production capability, storage and distribution capacity for medicines which could be used in the event of a bioterrorist attack.

National stockpiles

In order to be able to cope with bioterrorist attacks, most Member States have stockpiled antibiotics at national level, or are in the process of doing so. Two of the larger Member States have offered to share stocks with other Member States. However, the majority of the other Member States did not wish to take up the offers made and the sharing scheme was not discussed further.

As the smallpox virus is regarded as the agent of choice for the development of biological weapons – because it is highly contagious and potentially fatal – an assessment of national stockpiles of smallpox vaccines was carried out. The assessment showed that most Member States have or are acquiring stockpiles of smallpox vaccines.

EU-level stockpiles

No medicines have yet been stockpiled at Community level. However, the Commission/pharmaceutical industry task force and the Member States have highlighted the need to establish a Community stockpile of smallpox vaccines, antibiotics and antivirals.

As regards antibiotics, a Community stockpile should comprise a sufficient, versatile range of antibiotics to cover as many of the potential pathogens as possible. In addition to economies of scale, establishing this kind of Community stockpile would enhance the feeling of security among European citizens. However, creating a stockpile of antibiotics may also lead to difficulties concerning the choice of antibiotics within the different therapeutic classes and the choice of final manufactured product.

As regards smallpox vaccines, it has been recognised that such a stockpile should exist in addition to national stockpiles rather than replace them. It should also provide equivalent access to all and should ensure equity for all citizens of the EU. Consultations on options for a Community stockpile showed that most Member States do not support the establishment of a Community-level stockpile of smallpox vaccines.

Planned action

Action has been taken under the health security programme to address the needs for cooperation on medicines. In addition, developments on the production and availability of smallpox vaccines will be reviewed at regular intervals.

RESEARCH

At the initiative of the Commission, an R&D Expert Group on countering the effects of biological and chemical terrorism was set up in 2001. This group prepared a report comprising an inventory of the research activities undertaken in the Member States on the basis of which various recommendations have been formulated.

The fight against bioterrorism is an issue which could be addressed under the Sixth Framework Programme for Research, under the priorities “life sciences, genomics and biotechnology for health” and “food quality and safety”. Specific research needs could also be addressed in the “scientific support to policy” section of the programme where a specific action line has been introduced on “issues related to civil protection and crisis management”.

BUILDING A MULTI-SECTOR RESPONSE

Preventing terrorist acts and responding to their consequences requires the mobilisation of actors and resources in many sectors other than health. Sectors which should be given particular attention include the following:

  • food safety: the Community has a broad body of legislation which covers primary production of agricultural products and industrial production of processed food. There is therefore no need to establish new systems, but rather to adjust the current mechanisms in order to improve their functioning, taking into account the threat of bioterrorism;
  • animal safety: as is the case for food safety, the EU has a very comprehensive body of legislation in this area. It is therefore important to put these existing mechanisms to good use in order to take greater account of the threat of biological and chemical terrorism;
  • plant safety: the use of plant protection products on crops is part of the food chain management. Structures specifically intended to prevent the abuse of plant protection products are already in place in the Community in order to prevent or discover unintended contamination;
  • water safety: the joint Council/Commission programme called on Member States and the Community to examine whether Community measures on the quality of drinking water and surface waters were sufficient to meet requirements in relation to safety and early detection of infective agents and toxicants.

INTERNATIONAL COOPERATION

At the Ottawa meeting of November 2001, a Global Health Security Action Group was formed to implement the concerted action plan agreed at that meeting. The plan provides for the sharing of information and experience on preparedness and response plans, collaboration of laboratories, training for health staff and the development of risk management and communication methods.

The Commission is cooperating bilaterally with the World Health Organisation (WHO) on a number of subjects related to countering the effects of the deliberate release of biological and chemical agents. Meetings between the Council, the Commission and NATO have led to an exchange of documents on activities related to chemical, biological and radio-nuclear activities. These exchanges could serve as a reference point for further cooperation on the issue.

Related Acts

Commission Green Paper of 11 July 2007 on bio-preparedness [COM(2007) 399 final – Not published in the Official Journal].

Terrorism is considered one of the main challenges currently facing the European Union. The attacks in Madrid, London and New York made it clear that terrorism remains a threat to all countries. Terrorists may resort to non-conventional means such as biological materials, which have the capacity to infect thousands of people, destroy agriculture, infect animals and poison food. The risk of “bioterrorist” attacks is low, but the consequences of such acts can be devastating.

Naturally occurring diseases, laboratory accidents or other inadvertent releases of disease agents are another threat which could also harm European societies.

This Green Paper thus aims to launch a process of consultation at European level on how to reduce biological risks and enhance preparedness and response to biological threats.

The term “preparedness” covers all aspects of the issue, such as prevention, protection, first response capacity, prosecution of criminals, surveillance, research capacity, response and recovery.

This consultation process is mainly aimed at the national authorities responsible for risk prevention and response, public health and customs, law enforcement authorities, bio-industry and epidemiological and health professionals. It may lead to concrete actions in the field of bio-preparedness in 2008.

Replies from stakeholders had to be sent to the Commission by 1 October 2007.

Communication from the Commission of 28 November 2005 on strengthening coordination on generic preparedness planning for public health emergencies at EU level [COM(2005) 605 final – Not published in the Official Journal].
The purpose of this Communication is to assist Member States in developing generic plans for all sorts of public health emergencies, factoring in the EU dimension. The Communication serves as a reference point for the Member States to develop their own plans and identifies the key components to be taken into account when preparing for public health emergencies.

Communication from the Commission of 28 November 2001 entitled “Civil protection – State of preventive alert against possible emergencies” [COM(2001) 707 final – Not published in the Official Journal].

Decision No 2119/98/CE of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [Official Journal L 268 of 03.10.1998].


Another Normative about The fight against bioterrorism

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

The fight against bioterrorism (communication)

Document or Iniciative

Communication from the Commission of 2 June 2003 to the Council and the European Parliament on cooperation in the European Union on preparedness and response to Biological and Chemical agent attacks (Health security) [COM(2003) 320 final – Not published in the Official Journal].

Summary

This Communication is a follow-up to the unprecedented terrorist attacks in the USA in September 2001. Governments and international bodies responded to this event by examining the means they had at their disposal to prevent and counter threats and mitigate the effects of such attacks. They also undertook to develop appropriate responses to a new type of threat, that of deliberate releases of biological and chemical agents.

This Communication reports on the health aspects of European Union (EU) action against bioterrorism and reviews the measures taken to strengthen health defences against deliberate releases of biological and chemical agents. It also highlights the challenges facing the health sector in terms of preparedness and response.

RECENT BIOTERRORIST INCIDENTS AND REPERCUSSIONS IN THE EU

Shortly after the attacks of 11 September, the US was hit by a spate of bioterrorist incidents involving anthrax spores. These terrorist acts had a significant impact in Europe. Civil protection and security forces were put on alert, and public health systems had to deal with numerous items of mail containing powders suspected of being contaminated with anthrax. Although no bioterrorist attack was known to have taken place in Europe, the pressure on European countries was high, as they quickly had to devote resources to preventing a new type of threat. In January 2003, the discovery of ricin — a potentially fatal toxic substance — in a building in London served as a sharp reminder to emergency health services to intensify their efforts in the fight against bioterrorism.

The international community and the EU responded to this new threat by adopting the following measures:

  • conclusions of the Health Council of 15 November 2001: the Belgian Presidency adopted conclusions which called on the Commission to develop an action programme of cooperation on preparedness and response to biological and chemical agent threats;
  • Ottawa initiative: a meeting held in Ottawa on 7 November 2001 brought together the Health Ministers from the G7 group of countries, the Health Minister of Mexico and the Member of the Commission responsible for Health and Consumer Protection. The meeting agreed on concerted global action to strengthen the public health response to the threat of international biological, chemical and radio-nuclear terrorism;
  • Commission response: the Commission launched a series of coordinated actions across the civil protection, health, enterprise (pharmaceuticals), research, nuclear and transport and energy fields. These were reported in the communication on ” Civil protection: state of preventive alert against possible emergencies ” published in November 2001.
    On 20 December 2002, the Council and the Commission also adopted a joint programme to improve cooperation between Member States in the evaluation of Chemical, Biological and Radio-Nuclear (CBRN) risks, alerts and intervention, the storage of means of intervention and in the field of research.

PUBLIC HEALTH PREPAREDNESS AND RESPONSE

Preparedness

Mitigating the effects of deliberate releases of biological and chemical agents requires early detection of the agents implicated and case recognition of those affected. Health authorities and agencies have a crucial role here and must:

  • establish effective surveillance;
  • familiarise clinicians with the syndromes to look out for;
  • disseminate case management guidelines;
  • put in place effective arrangements for prompt notifications to the authorities in charge of collecting and evaluating epidemiological information;
  • coordinate public health responses.

The necessary laboratory expertise and capacity must be available to cope with high-risk agents and complex technology as well as a surge in demand in case of multiple attacks.

Response

In the event of an attack, measures for physical protection and assistance must be able to be taken immediately and an initial assessment made of consequences and risks so that appropriate action can be initiated forthwith. The health authorities are responsible for taking preventive, remedial and treatment action (decontaminating exposed persons, taking swabs for analysis, administering prophylactic treatments, etc.). In addition, emergency plans provide a high degree of confidence in the capacity to mount an effective multi-sector response. The means of response and the deployment capability of health response staff must be strengthened in order to optimise their ability to cope in the event of an attack.

Coordination in the EU

The EU is a border-free area, so it is essential for appropriate arrangements to be put in place to ensure prompt notification and exchange of information in the event of threats and attacks. The importance of joint action in the EU led to the establishment in October 2001 of a Health Security Committee, comprised of representatives of the Health Ministers, to promote cooperation in countering bioterrorism. The Committee agreed a programme of cooperation on preparedness and response to biological and chemical agent attacks, code-named BICHAT, based on four objectives:

  • To set up an alert and information exchange mechanism
    This mechanism consists of a Health Security Committee and a rapid alert system. The Health Security Committee is responsible for exchanging information on health-related threats, on preparedness and response plans and crisis management strategies. The rapid alert system (code-named “RAS-BICHAT”) has been in operation since June 2002 for notifications of incidents involving the deliberate release of biological and chemical agents to cause harm;
  • To create a capability for the detection and identification of biological and chemical agents that might be used in attacks.
    Detection of deliberate releases of biological agents relies first and foremost on Member States’ surveillance systems for monitoring the occurrence of infectious diseases. It is essential that Member States continue to develop new diagnostics for rapid detection. Coordination of these surveillance systems at EU level is conducted in line with a Decision of September 1998 on the surveillance and control of communicable diseases.
    Biological agents likely to be used in bioterrorism have already been prioritised on the basis of various criteria. In addition, a Council Regulation (No 1334/2000) lays down various lists of biological and chemical agents for which provisions linked to export control arrangements apply.
    Laboratory capacity continues to be insufficient in many Member States. It is therefore imperative that Member States share resources and that those with advanced facilities assist those without;
  • To create a database on medicines stock and health services (see next section) and a stand-by facility for making medicines and health care specialists available in case of attack;
  • To draw up rules and disseminate guidance on responding to attacks from the health point of view and coordinating the EU response and links with third countries and international organisations. Consultations in the EU and internationally showed that the process of adjusting national emergency plans to the new threat of covert release of chemical and biological agents was not yet complete in the Member States. Moreover, it is a priority to intensify work on emergency planning and promote modelling in order to reinforce emergency plans for threats and attacks.

In February 2007, the Council extended the mandate of this Health Security Committee by three years.

AVAILABILITY AND STOCKPILING OF MEDICINES

The bioterrorist attacks in the USA highlighted the fundamental importance of the availability of medicines in the EU and the capability of industry to make good any shortcoming in production and supply. A joint Commission/pharmaceutical industry task force was established in December 2001 to address issues of availability, production capability, storage and distribution capacity for medicines which could be used in the event of a bioterrorist attack.

National stockpiles

In order to be able to cope with bioterrorist attacks, most Member States have stockpiled antibiotics at national level, or are in the process of doing so. Two of the larger Member States have offered to share stocks with other Member States. However, the majority of the other Member States did not wish to take up the offers made and the sharing scheme was not discussed further.

As the smallpox virus is regarded as the agent of choice for the development of biological weapons – because it is highly contagious and potentially fatal – an assessment of national stockpiles of smallpox vaccines was carried out. The assessment showed that most Member States have or are acquiring stockpiles of smallpox vaccines.

EU-level stockpiles

No medicines have yet been stockpiled at Community level. However, the Commission/pharmaceutical industry task force and the Member States have highlighted the need to establish a Community stockpile of smallpox vaccines, antibiotics and antivirals.

As regards antibiotics, a Community stockpile should comprise a sufficient, versatile range of antibiotics to cover as many of the potential pathogens as possible. In addition to economies of scale, establishing this kind of Community stockpile would enhance the feeling of security among European citizens. However, creating a stockpile of antibiotics may also lead to difficulties concerning the choice of antibiotics within the different therapeutic classes and the choice of final manufactured product.

As regards smallpox vaccines, it has been recognised that such a stockpile should exist in addition to national stockpiles rather than replace them. It should also provide equivalent access to all and should ensure equity for all citizens of the EU. Consultations on options for a Community stockpile showed that most Member States do not support the establishment of a Community-level stockpile of smallpox vaccines.

Planned action

Action has been taken under the health security programme to address the needs for cooperation on medicines. In addition, developments on the production and availability of smallpox vaccines will be reviewed at regular intervals.

RESEARCH

At the initiative of the Commission, an R&D Expert Group on countering the effects of biological and chemical terrorism was set up in 2001. This group prepared a report comprising an inventory of the research activities undertaken in the Member States on the basis of which various recommendations have been formulated.

The fight against bioterrorism is an issue which could be addressed under the Sixth Framework Programme for Research, under the priorities “life sciences, genomics and biotechnology for health” and “food quality and safety”. Specific research needs could also be addressed in the “scientific support to policy” section of the programme where a specific action line has been introduced on “issues related to civil protection and crisis management”.

BUILDING A MULTI-SECTOR RESPONSE

Preventing terrorist acts and responding to their consequences requires the mobilisation of actors and resources in many sectors other than health. Sectors which should be given particular attention include the following:

  • food safety: the Community has a broad body of legislation which covers primary production of agricultural products and industrial production of processed food. There is therefore no need to establish new systems, but rather to adjust the current mechanisms in order to improve their functioning, taking into account the threat of bioterrorism;
  • animal safety: as is the case for food safety, the EU has a very comprehensive body of legislation in this area. It is therefore important to put these existing mechanisms to good use in order to take greater account of the threat of biological and chemical terrorism;
  • plant safety: the use of plant protection products on crops is part of the food chain management. Structures specifically intended to prevent the abuse of plant protection products are already in place in the Community in order to prevent or discover unintended contamination;
  • water safety: the joint Council/Commission programme called on Member States and the Community to examine whether Community measures on the quality of drinking water and surface waters were sufficient to meet requirements in relation to safety and early detection of infective agents and toxicants.

INTERNATIONAL COOPERATION

At the Ottawa meeting of November 2001, a Global Health Security Action Group was formed to implement the concerted action plan agreed at that meeting. The plan provides for the sharing of information and experience on preparedness and response plans, collaboration of laboratories, training for health staff and the development of risk management and communication methods.

The Commission is cooperating bilaterally with the World Health Organisation (WHO) on a number of subjects related to countering the effects of the deliberate release of biological and chemical agents. Meetings between the Council, the Commission and NATO have led to an exchange of documents on activities related to chemical, biological and radio-nuclear activities. These exchanges could serve as a reference point for further cooperation on the issue.

Related Acts

Commission Green Paper of 11 July 2007 on bio-preparedness [COM(2007) 399 final – Not published in the Official Journal].

Terrorism is considered one of the main challenges currently facing the European Union. The attacks in Madrid, London and New York made it clear that terrorism remains a threat to all countries. Terrorists may resort to non-conventional means such as biological materials, which have the capacity to infect thousands of people, destroy agriculture, infect animals and poison food. The risk of “bioterrorist” attacks is low, but the consequences of such acts can be devastating.

Naturally occurring diseases, laboratory accidents or other inadvertent releases of disease agents are another threat which could also harm European societies.

This Green Paper thus aims to launch a process of consultation at European level on how to reduce biological risks and enhance preparedness and response to biological threats.

The term “preparedness” covers all aspects of the issue, such as prevention, protection, first response capacity, prosecution of criminals, surveillance, research capacity, response and recovery.

This consultation process is mainly aimed at the national authorities responsible for risk prevention and response, public health and customs, law enforcement authorities, bio-industry and epidemiological and health professionals. It may lead to concrete actions in the field of bio-preparedness in 2008.

Replies from stakeholders had to be sent to the Commission by 1 October 2007.

Communication from the Commission of 28 November 2005 on strengthening coordination on generic preparedness planning for public health emergencies at EU level [COM(2005) 605 final – Not published in the Official Journal].
The purpose of this Communication is to assist Member States in developing generic plans for all sorts of public health emergencies, factoring in the EU dimension. The Communication serves as a reference point for the Member States to develop their own plans and identifies the key components to be taken into account when preparing for public health emergencies.

Communication from the Commission of 28 November 2001 entitled “Civil protection – State of preventive alert against possible emergencies” [COM(2001) 707 final – Not published in the Official Journal].

Decision No 2119/98/CE of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [Official Journal L 268 of 03.10.1998].

Classification, packaging and labeling of chemicals and their mixtures

Classification, packaging and labeling of chemicals and their mixtures

Outline of the Community (European Union) legislation about Classification, packaging and labeling of chemicals and their mixtures

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

Classification, packaging and labeling of chemicals and their mixtures

Document or Iniciative

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 [See amending act(s)].

Summary

This Regulation harmonises requirements concerning the classification, labelling and packaging of chemical substances and mixtures in line with the international system approved by the United Nations. This harmonisation enhances protection of health and the environment, and improves the free circulation of chemical substances and mixtures.

Enterprises must classify, label and pack their substances and mixtures in line with the provisions of this Regulation before putting them on the market.

Scope

The Regulation covers chemical substances and mixtures which are composed of two chemical substances or more.

The Regulation does not apply to:

  • radioactive substances and mixtures covered by Directive 96/29/Euratom;
  • substances subject to customs supervision which are in temporary storage, in a free zone or free warehouse with a view to re-exportation or still in transit;
  • non-isolated intermediates (substances which are manufactured in order to be chemically transformed into another substance);
  • substances and mixtures for scientific research and development which are not placed on the market;
  • waste;
  • medicinal products;
  • cosmetic products;
  • some medical devices;
  • food;
  • the transport of dangerous goods.

Classification

The classification of chemical substances and mixtures is based on categories which take into account the degree of hazard and the specific nature of the hazardous properties. These include inflammable substances or mixtures, those which are highly toxic, those which are dangerous for the aquatic environment, etc. Annex I establishes the criteria for the classification and labelling of hazardous substances and mixtures.

The Annexes of the Regulation also include the list of hazard statements, the list of precautionary statements, pictograms for each hazard class and the lists of classifications and labelling harmonised at Community level.

Labelling

Labelling must mention:

  • the name of the substance or mixture and/or an identification number;
  • the name, address and telephone number of the supplier;
  • the nominal quantity of the substance or mixture.

If applicable, labelling must include:

  • hazard pictograms (see Annex V of the Regulation);
  • the signal words “Danger” or “Warning”;
  • hazard statements such as “Fire or projection hazard”, “Fatal if swallowed”, etc. (see Annex III of the Regulation);
  • precautionary statements such as “Keep only in original container”, “Protect from moisture”, “Keep out of reach of children”, etc. (see Annex IV of the Regulation);
  • supplemental information, for example on physical properties or health hazards (see Annex II of the Regulation).

Hazard pictograms shall be in the shape of a square set at a point. They shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible. Each hazard pictogram shall cover at least one fifteenth of the surface area of the harmonised label and the minimum area shall not be less than 1 cm2.

The dimensions of the label shall be as follows:

Capacity of the package Dimensions (in millimetres)
Not exceeding 3 litres If possible, at least 52 × 74
Greater than 3 litres but not exceeding 50 litres At least 74 × 105
Greater than 50 litres but not exceeding 500 litres At least 105 × 148
Greater than 500 litres At least 148 × 210

The label for the hazardous substance or mixture shall be written in the official language(s) of the Member State where it is placed on the market, unless the Member State concerned provides otherwise.

Hazard pictograms, signal words, hazard statements and precautionary statements shall be located together on the label in an order established by the supplier, provided that the statements are grouped by language.

Packaging

Packaging containing hazardous substances or mixtures shall comply with the following requirements:

  • packaging must prevent any of the contents escaping;
  • packaging must be made of materials which are resistant if they come into contact with the contents;
  • packaging must be strong and solid;
  • packaging must have sealable fastenings.

In some cases, child-resistant fastenings and tactile warnings are required.

Harmonisation procedure

In order to trigger the harmonisation procedure for the classification and labelling of substances, Member States, or even manufacturers, importers or downstream users, can submit a proposal for the harmonised classification and labelling of substances, containing the information set out in Annex VI, Part 1 of this Regulation to the European Chemicals Agency. Generally, only substances satisfying the classification criteria for Category 1 respiratory sensitisation, mutagenicity, carcinogenicity or reproductive toxicity, or active ingredients in pesticides or biocides will be subject to such harmonisation, but other substances may be subject thereto if a necessity for harmonisation is demonstrated.

Within eighteen months from receipt of the proposal, the risk assessment committee of the Agency shall give an opinion on the proposal.

The Agency shall send this opinion to the Commission which, if it considers that harmonisation is appropriate, will include the substance and its classification and labelling elements in Annex VI, Part 3 of this Regulation.

The classification and labelling inventory

At the latest one month after having placed a substance on the market, the manufacturer or importer shall notify the Agency of information concerning its identity, the identity of the substance, hazard classes, concentration limits, etc. All this information shall be included in an inventory of classification and labelling that the Agency shall update on a regular basis.

Context

This Regulation supplements the REACH system for registration, assessment, authorisation and restrictions concerning chemical substances.

This Regulation amends Directive 67/548/EEC on chemical substances and Directive 1999/45/EC on mixtures and repeals them with effect from 1June 2015.

References

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

Regulation (EC) No 1272/2008

20.1.2009
1.12.2010 (Titles II, III and IV for substances)
1.6.2015 (Titles II, III and IV for mixtures)

OJ L 353, 31.12.2008

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

Regulation (EC) No 286/2011

19.4.2011

OJ L 83, 30.3.2011

AMENDMENTS TO THE ANNEXES

Annex I – Classification and labelling requirements
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex II – Special rules for labelling and packaging
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex III – List of hazard statements
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex IV – List of precautionary statements
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex V – Hazard pictograms
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex VI – List of harmonised classification and labelling of hazardous substances
Regulation (EC) No 790/2009 [Official Journal L 235 of 5.9.2009];
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annexe VII – Translation table
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

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)