Category Archives: Plant Health Checks

In order to prevent any risk to human food and animal feed and to guarantee healthy and good quality crops, the EU places great emphasis on plant and crop protection. There are therefore checks on the movement of plants within the EU or from third countries in order to combat the emergence and spread of harmful organisms. The EU also ensures that plant health products are not harmful to health or the environment, specifically through an authorisation system and maximum residue limits in plants.

Supplementary protection certificate for plant protection products

Supplementary protection certificate for plant protection products

Outline of the Community (European Union) legislation about Supplementary protection certificate for plant protection products

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

Supplementary protection certificate for plant protection products

Document or Iniciative

Regulation (EC) No 1610/96 of the European Parliament and of the Council concerning the creation of a supplementary protection certificate for plant protection products *

Summary

The Regulation defines the characteristics of the supplementary protection certificate * and lays down the conditions for obtaining a certificate.

The certificate is issued for:

  • any product protected by a basic patent * in force;
  • any plant protection product that has been granted marketing authorisation (this must be the first marketing authorisation) in accordance with Directive 91/414/EEC or an earlier provision of national law;
  • any product that has not already been the subject of a certificate.

The certificate confers the same rights as those conferred by the basic patent and is subject to the same limitations and obligations.

The certificate is granted to the holder of the basic patent or his successor in title.

The application for a certificate must be lodged:

  • within six months of the date on which marketing authorisation was granted for the plant protection product;
  • with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the marketing authorisation was obtained.

The Regulation provides for publication of the fact that the certificate has been granted.

Member States may require that the certificate be subject to the payment of annual fees.

The duration of the certificate may not exceed five years from the date on which it takes effect.

The certificate lapses:

  • on expiry of its period of validity;
  • if the certificate-holder surrenders it;
  • if the annual fee is not paid in time;
  • if the marketing authorisation is withdrawn.

The certificate is invalid if:

  • it was granted contrary to the provisions set out above;
  • the basic patent has lapsed before its lawful term expires;
  • the basic patent is revoked or limited.

Any person may submit an application or bring an action for the certificate to be declared invalid.

Key terms used in the act

Plant protection products: active substances and preparations containing one or more active substances which do one or more of the following:
a) protect plants or plant products against all harmful organisms or prevent the action of such organisms;
b) influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
c) preserve plant products, in so far as such substances or products are not subject to special provisions on preservatives;
d) destroy undesirable plants; or
e) destroy parts of plants, check or prevent undesirable growth of plants.
Active substances: substances or micro-organisms including viruses having general or specific action against harmful organisms or on plants, parts of plants or plant products.
Basic patent: a patent which protects a product, a preparation, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a supplementary protection certificate.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1610/96 8.02.1997 OJ L 198 of 08.08.1996

 

Placing of plant protection products on the market

Placing of plant protection products on the market

Outline of the Community (European Union) legislation about Placing of plant protection products on the market

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

Placing of plant protection products on the market

Document or Iniciative

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.

Summary

The Regulation confirms the importance that the European Commission places on a higher level of health and environmental protection, whilst seeking to harmonise the placing of plant protection products * on the market. Furthermore, it aims to improve agricultural production.

The scope of this Regulation covers plant protection products and their active substances *.

The Regulation lays down approval criteria for active substances. An active substance shall be approved if it fulfils the criteria detailed in points 2 and 3 of Annex II to the Regulation. These criteria relate to the efficacy of the substance, its composition, its characteristics, the methods of analysis available, the impact on human health and the environment, ecotoxicology and the relevance of metabolites and residues. As such, an active substance shall only be approved if it is not classified as category 1A or 1B mutagenic, carcinogenic or toxic for reproduction, and is not considered to have endocrine disrupting properties. Furthermore, an active substance which is considered to be a persistent organic pollutant, or as persistent, bioaccumulative and toxic, or even as a very persistent and very bioaccumulative substance, shall not be approved.

The first approval is valid for a limited period which cannot exceed ten years and may be subject to certain conditions or restrictions regarding, for example, the purity of the active substance, the intended crop and the category of user.

Authorisation to place plant protection products on the market remains the responsibility of Member States. Applications are submitted to the Member State where the product is intended to be placed on the market for the first time. Applications shall be accompanied by two dossiers containing all the information available to enable the potential effects of the plant protection product on human and animal health, and the possible impact on the environment, to be assessed. The information provided by the applicant or the producer may be protected by a confidentiality clause if it constitutes an industrial or trade secret.

The time required to examine the application for authorisation to place a plant protection product on the market is limited to a period of twelve months, commencing on the date that the Member State receives the application. During this period, the Member State shall check whether the product concerned satisfies the authorisation conditions. If further information is required, the Member State may extend the initial assessment period in order to allow the applicant time to provide it. This period may not exceed six months and shall expire when the Member State receives the additional information. Where at the end of that period, the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible.

Authorisation for placing on the market is valid for 10 years and may be renewed. A Member State may review an authorisation at any time if it no longer complies with one of the pre-conditions for placing on the market. Should this be the case, a Member State may withdraw or amend the authorisation.

The principle of mutual recognition established in this Regulation enables the holder of an authorisation to place the product on the market in another Member State insofar as the agricultural, plant health and environmental conditions are comparable in the regions concerned. However, the Member State may provisionally limit or ban the movement of a product on its territory if the product in question presents a risk to human or animal health, or to the environment.

In order to ensure protection for certain crops, the Regulation enables the holder of an authorisation for a plant protection product which has already been authorised in the Member State concerned, to request that the authorisation be extended to minor uses not yet covered by that authorisation. These extensions of use are also covered by the principle of mutual recognition.

Member States shall update the information on authorised or withdrawn plant protection products at least once every three months. This information shall be accessible to the public.

A provisional authorisation may be granted for the placing on the market of plant protection products containing an active substance which has not yet been approved. The provisional authorisation shall be granted for a period not exceeding three years.

The classification, labelling and packaging of plant protection products is also subject to the requirements provided for by Directive 1999/45/EC regarding dangerous preparations. The packaging of the aforementioned products should prevent consumers from using the products incorrectly.

Member States shall carry out official controls in order to enforce compliance with this Regulation. They shall finalise and transmit to the Commission a report on the scope and the results of these controls within six months of the end of the year to which the report relates. The Commission shall call on experts to carry out general and specific audits in the Member States. The aim of these audits is to verify the official controls carried out by the Member States.

The Commission may adopt emergency measures in order to restrict or prohibit the use and/or sale of a plant protection product if it is likely to constitute a serious risk to human or animal health or the environment, and that such a risk cannot be contained by the Member State(s) concerned.

Context

On 14 June 2011, this Regulation shall repeal and replace:

  • Directive 79/117/EEC concerning prohibited plant protection products; and
  • Directive 91/414/EEC concerning authorised plant protection products.
Key terms of the Act
  • Plant protection product: products consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:
    1. protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;
    2. influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient;
    3. preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives;
    4. destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants;
    5. checking or preventing undesired growth of plants, except algae.
  • Active substances: substances or micro-organisms, including viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1107/2009

14.12.2009

OJ L 309 of 24.11.2009

Protection against organisms harmful to plants and plant products

Protection against organisms harmful to plants and plant products

Outline of the Community (European Union) legislation about Protection against organisms harmful to plants and plant products

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

Protection against organisms harmful to plants and plant products

Document or Iniciative

Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community [See amending acts].

Summary

This Directive lays down measures designed to protect Member States against the introduction of organisms harmful to plants and plant products from other Member States or third countries.

This Directive also lays down measures designed to protect Member States against the spread of harmful organisms within the European Union (EU).

Scope

The Directive covers living plants and living parts of plants, including seeds.

Living parts of plants are:

  • fruit and vegetables that have not been deep-frozen,
  • tubers, corms, bulbs, rhizomes,
  • cut flowers,
  • cut trees and branches with foliage,
  • leaves,
  • live pollen,
  • grafts and any other part of a plant.

Plant products are products of plant origin, unprocessed or having undergone simple preparation, other than the items listed above. Wood as such is also covered in some cases.

Harmful organisms” as defined by the Directive means pests of plants or of plant products, which belong to the animal or plant kingdoms, or which are pathogens. This definition covers in particular insects and mites, bacteria, fungi, viruses and parasite plants. Annexes I and II list the harmful organisms banned in the EU, either altogether or when they are on certain plants or plant products. Annex III lists plants and plant products that must not be imported from certain countries.

The protective measures also relate to the means by which plants, plant products and other related items are moved (packaging, vehicles, etc.).

The protective measures also cover the movement of plants and plant products between the EU and some of its outermost regions, namely the French overseas departments and the Canary Islands.

Placing on the market and intra-Community trade

This Directive requires certain plants and plant products (Annex V, part A) to undergo a plant-health inspection. This inspection must take place at least once a year at the place of production, at appropriate times, i.e. during the growth period or just after harvesting. It applies to plants and plant products at the production site and their growing environment.

Producers must be listed on an official register held by the national body responsible.

Exemptions may be granted for products for the local market if there is no risk of the harmful organism spreading.

When the check gives satisfactory results, the national body responsible issues a plant passport attesting compliance with Community plant-health rules. This passport is usually in the form of a standard label to be affixed to the product, its packaging or sometimes the vehicle in which it is transported. The passport may be replaced in certain circumstances (change of plant health status, division into batches, etc.) and subject to certain conditions.

Where the results of a check are not satisfactory, the plants, plant products and growing media concerned may be subject to various measures such as appropriate treatment (if this is successful, the passport is then issued), movement under official control, or destruction. The Member States must also notify the Commission and the other Member States of the presence of harmful organisms or the risk of their entering or spreading on their territory.

In addition to plant-health inspection, Member States are to organise occasional checks, whether at the place where plants or plant products are grown, produced, stored, offered for sale or moved, or at the same time as any other documentary check which is carried out for reasons other than plant health.

Imports from third countries

This Directive subjects certain plants and plant products from other countries (Annex V, part B) to a check on entry into EU territory. This involves a documentary check, an identity check and a plant-health check.

The documentary check consists in checking certificates and documents accompanying the consignment or batch, in particular the plant-health certificate. This is issued by the authority responsible in the country of origin or re-export, using models drawn up by the Commission. It has to certify that the products have undergone appropriate and satisfactory inspections.

The identity check involves checking that the consignment tallies with the plants or plant products covered by the certificate.

The plant-health check involves checking, on the basis of a complete examination or an examination of samples, that the plants or plant products show no signs of contamination by harmful organisms and that they meet the specific requirements defined in this Directive.

The Directive provides for less stringent identity and plant-health checks where certain guarantees are provided.

It also provides for exemptions where there is no risk of harmful organisms spreading, in particular in the following cases:

  • where plants of plant products are merely in transit from one point in the EU territory to another via a third country or from a point in one non-EU country to a point in another non-EU country via EU territory.
  • where small quantities of plants or plant products are not intended for industrial or commercial purposes or are to be consumed during transport are involved;
  • where plants or plant products are intended for trials or scientific purposes and for work on varietal selections;
  • where plants or plant products are grown, produced or used in the immediate frontier zone between a Member State and a third country.

Importers of certain plants or plant products (Annex V) must be on their Member State’s official register.

If the results of the checks are satisfactory, instead of a phytosanitary certificate a passport and the rules applicable to intra-Community movement apply. If not, one or more of the following measures may be taken: access to EU territory may be refused, the consignment may be sent back to a destination outside the EU, the contaminated products may be removed from the consignment, destroyed, placed in quarantine pending further tests, or treated appropriately (this last measure is possible only in exceptional cases and under very precise circumstances). The Member State concerned must also inform the Commission and the other Member States of the situation and what measures have been taken.

Protected zones

The Directive establishes, at the request of one or more Member States, special protected zones to guard against certain harmful organisms. Each zone may cover all or part of the territory of a Member State and must be defined in specific geographic terms and in relation to the harmful organisms concerned.

The reason for this protection is the absence of specified harmful organisms in this zone despite conditions favourable to their development.

The additional protection provided in the protected zones includes:

  • an additional list of harmful organisms the introduction and spread of which in the protected zones is prohibited;
  • an additional list of plants and plant products the introduction of which into the protected zones is prohibited;
  • an additional list of specific requirements to be met by certain crops and crop products when they are introduced into or moved within the EU.

National official bodies

The national official bodies may delegate the tasks attributed to them under this Directive to any legal person, whether governed by public or private law. Tasks relating to laboratory analyses may also be delegated. However, in this specific case, the national official body shall ensure that:

  • the legal person responsible for carrying out the analyses is able to guarantee impartiality and quality as well as the protection of confidential information;
  • that there are no conflicts of interest between the tasks entrusted to the legal person and the latter’s other activities.

Background

This Directive replaces and consolidates Directive 77/93/EEC and subsequent amendments. It is based on the principles accepted internationally in the International Plant Protection Convention (IPPC) of the Food and Agriculture Organisation (FAO) and the WTO SPS (sanitary and phytosanitary measures) agreement.

References

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

Directive 2000/29/EC

30.7.2000

20.1.2002

OJ L 169 of 10.7.00

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

Directive 2002/89/EC

30.12.2002

1.1.2005

OJ L 355 of 30.12.2002

Regulation (EC) No 882/2004

20.5.2004

OJ L 165 of 30.4.2004

Directive 2009/143/EC

24.12.2009

1.1.2011

OJ L 318 of 4.12.2009

Successive amendments and corrections to Directive 2000/29/EC have been incorporated into the basic text. This consolidated versionis for reference only.

AMENDMENTS TO THE ANNEXES

Annex I

Directive 2002/28/EC [Official Journal L 77 of 20.3.2002];
Directive 2002/36/EC [Official Journal L 116 of 03.5.2002];
Directive 2003/22/EC [Official Journal L 78 of 25.3.2003];
Directive 2004/31/EC [Official Journal L 85 of 23.3.2004];
Directive 2004/70/EC [Official Journal L 127 of 29.4.2004];
Directive 2005/16/EC [Official Journal L 57 of 3.3.2005];
Directive 2006/35/EC [Official Journal L 88 of 25.3.2006];
Directive 2008/64/EC [Official Journal L 168 of 28.6.2008];
Directive 2009/7/EC [Official Journal L 40 of 11.2.2009].

Annex II

Directive 2002/28/EC [Official Journal L 77 of 20.3.2002];
Directive 2002/36/EC [Official Journal L 116 of 3.5.2002];
Directive 2003/22/EC [Official Journal L 78 of 25.3.2003];
Directive 2003/47/EC [Official Journal L 138 of 5.6.2003];
Directive 2003/116/EC [Official Journal L 321 of 6.12.2003];
Directive 2004/31/EC [Official Journal L 85 of 23.3.2004];
Directive 2004/70/EC [Official Journal L 127 of 29.4.2004];
Directive 2004/102/EC [Official Journal L 309 of 6.10.2004];
Directive 2005/16/EC [Official Journal L 57 of 3.3.2005];
Directive 2006/35/EC [Official Journal L 88 of 25.3.2006];
Directive 2007/41/EC [Official Journal L 169 of 29.6.2007];
Directive 2008/64/EC [Official Journal L 168 of 28.6.2008];
Directive 2009/7/EC [Official Journal L 40 of 11.2.2009];
Directive 2009/118/EC [Official Journal L 239 of 10.9.2009];
Directive 2010/1/EU [Official Journal L 7 of 12.1.2010].

Annex III

Directive 2002/28/EC [Official Journal L 77 of 20.3.2002];
Directive 2003/22/EC [Official Journal L 78 of 25.3.2003];
Directive 2003/116/EC [Official Journal L 321 of 6.12.2003];
Directive 2004/31/EC [Official Journal L 85 of 23.3.2004];
Directive 2004/70/EC [Official Journal L 127 of 29.4.2004];
Directive 2004/102/EC [Official Journal L 309 of 6.10.2004];
Directive 2005/16/EC [Official Journal L 57 of 3.3.2005];
Directive 2006/35/EC [Official Journal L 88 of 25.3.2006].
Directive 2008/64/EC [Official Journal L 168 of 28.6.2008].
Directive 2009/118/EC [Official Journal L 239 of 10.9.2009];
Directive 2010/1/EU [Official Journal L 7 of 12.1.2010].

Annex IV

Directive 2002/28/EC [Official Journal L 77 of 20.3.2002];
Directive 2002/36/EC [Official Journal L 116 of 3.5.2002];
Directive 2003/22/EC [Official Journal L 78 of 25.3.2003];
Directive 2003/47/EC[Official Journal L 138 of 5.6.2003];
Directive 2003/116/EC [Official Journal L 321 of 6.12.2003];
Directive 2004/31/EC [Official Journal L 85 of 23.3.2004];
Directive 2004/70/EC [Official Journal L 127 of 29.4.2004];
Directive 2004/102/EC [Official Journal L 309 of 6.10.2004];
Directive 2005/15/EC [Official Journal L 56 of 2.3.2005];
Directive 2005/16/EC [Official Journal L 57 of 3.3.2005];
Directive 2006/14/EC [Official Journal L 34 of 7.2.2006];
Directive 2006/35/EC [Official Journal L 88 of 25.3.2006];
Directive 2007/41/EC [Official Journal L 169 of 29.6.2007].
Directive 2008/64/EC [Official Journal L 168 of 28.6.2008].
Directive 2009/7/EC [Official Journal L 40 of 11.2.2009];
Directive 2009/118/EC [Official Journal L 239 of 10.9.2009];
Directive 2010/1/EU [Official Journal L 7 of 12.1.2010].

Annex V

Directive 2002/36/EC [Official Journal L 116 of 3.5.2002];
Directive 2003/22/EC [Official Journal L 78 of 25.3.2003];
Directive 2003/47/EC [Official Journal L 138 of 5.6.2003];
Directive 2003/116/EC [Official Journal L 321 of 6.12.2003];
Directive 2004/31/EC [Official Journal L 85 of 23.3.2004];
Directive 2004/102/EC [Official Journal L 309 of 6.10.2004];
Directive 2005/16/EC [Official Journal L 57 of 3.3.2005];
Directive 2005/77/EC [Official Journal L 296 of 12.11.2005];
Directive 2007/41/EC [Official Journal L 169 of 29.6.2007].
Directive 2009/7/EC [Official Journal L 40 of 11.2.2009];
Directive 2009/118/EC [Official Journal L 239 of 10.9.2009].

Annex VIII

Directive 2002/89/EC [Official Journal L 355 of 30.12.2002].

Related Acts

Commission Regulation (EC) No 690/2008 of 4 July 2008 recognising protected zones exposed to particular plant health risks in the Community [Official Journal L 193 of 22.7.2008].
See consolidated version

Commission Directive 2008/61/EC of 17 June 2008 fixing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 2000/29/EC may be introduced or moved within the Community or certain protected zones thereof, for trial or scientific purposes and for work on varietal selections [Official Journal L 158 of 18.6.2008].

Commission Directive 2004/105/EC of 15 October 2004 determining the models of official phytosanitary certificates or phytosanitary certificates for re-export accompanying plants, plant products or other objects from third countries and listed in Council Directive 2000/29/EC [Official Journal L 319 of 20.10.2004].

Commission Regulation (EC) No 1756/2004 of 11 October 2004 specifying the detailed conditions for the evidence required and the criteria for the type and level of the reduction of the plant health checks of certain plants, plant products or other objects listed in Part B of Annex V to Council Directive 2000/29/EC [Official Journal L 313 of 12.10.2004].

Commission Directive 2004/103/EC of 7 October 2004 on identity and plant health checks of plants, plant products or other objects, listed in Part B of Annex V to Council Directive 2000/29/EC, which may be carried out at a place other than the point of entry into the Community or at a place close by and specifying the conditions related to these checks [Official Journal L 313 of 12.10.2004]

Commission Regulation (EC) No 1040/2002 of 14 June 2002 establishing detailed rules for the implementation of the provisions relating to the allocation of a financial contribution from the Community for plant-health control and repealing Regulation (EC) No 2051/97 [Official Journal L 157 of 15.6.2002].
See consolidated version

Commission Regulation (EC) No 997/2002 of 11 June 2002 establishing detailed rules for the implementation of the provisions relating to the allocation of a Community financial contribution for Member States in order to strengthen inspection infrastructures for plant health checks on plants and plant products coming from third countries [Official Journal L 152 of 12.06.2002].

Commission Directive 92/105/EEC of 3 December 1992 establishing a degree of standardisation for plant passports to be used for the movement of certain plants, plant products or other objects within the Community, and establishing the detailed procedures related to the issuing of such plant passports and the conditions and detailed procedures for their replacement [Official Journal L 4 of 8.1.1993].
Amended by:


Directive 2005/17/EC [Official Journal L 57 of 3.3.2005].

Commission Directive 92/90/EEC of 3 November 1992 establishing obligations to which producers and importers of plants, plant products or other objects are subject and establishing details for their registration [Official Journal L 344 of 26.11.1992].

Plant health checks

Plant health checks

Outline of the Community (European Union) legislation about Plant health checks

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

Plant health checks

In order to prevent any risk to human food and animal feed and to guarantee healthy and good quality crops, the EU places great emphasis on plant and crop protection. There are therefore checks on the movement of plants within the EU or from third countries in order to combat the emergence and spread of harmful organisms. The EU also ensures that plant health products are not harmful to health or the environment, specifically through an authorisation system and maximum residue limits in plants.

PHYTOPHARMACEUTICAL PRODUCTS: EVALUATION AND AUTHORISATION

  • Placing of plant protection products on the market
  • The placing of plant protection products on the market (until June 2011)
  • Plant protection products prohibited (until June 2011)
  • Supplementary protection certificate for plant protection products
  • Training of food safety control authorities

PESTICIDE RESIDUES

  • Biocides
  • Pesticides
  • Maximum pesticide limits for food products for human consumption and animal feedingstuffs
  • Towards a thematic strategy on the sustainable use of pesticides

PLANT HEALTH AND PLANT PROTECTION – HARMFUL ORGANISMS

  • Protection against organisms harmful to plants and plant products

The placing of plant protection products on the market

The placing of plant protection products on the market

Outline of the Community (European Union) legislation about The placing of plant protection products on the market

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

The placing of plant protection products on the market (until June 2011)

The European Union has harmonised the conditions and procedures for authorising plant protection products so as to protect human health and the environment. It has also drawn up a list of authorised substances and a phased programme for evaluating substances already on the market.

Document or Iniciative

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [See Amending Acts].

Summary

The Directive lays down uniform rules on the evaluation, authorisation, placing on the market and control within the European Union of plant protection products * and the active substances * they contain.

Only plant protection products whose active substances are listed in Annex I to the Directive and that do not pose a risk to human or animal health or the environment when the product is used under normal conditions are authorised.

The procedure for evaluating and authorising plant protection products must comply with the uniform principles laid down in Annex VI to the Directive. These include:

  • general principles: the evaluation of data in the light of current knowledge, taking account of the particular conditions prevailing in the zone in which the product is to be used, etc;
  • specific principles concerning, among other things, efficacy, the absence of unacceptable effects on plants, the impact on human and animal health and on non-target species, distribution in and impact on the environment, etc.

The Directive stipulates the requirements for the dossier to be submitted for the inclusion of an active substance in the list of authorised substances (Annex II) and the requirements for the dossier to be submitted for the authorisation of a plant protection product (Annex III). These requirements concern, among other things, the identification of the substance or product, the identity of the manufacturer and applicant for authorisation, tests and analyses carried out by official or officially-recognized testing facilities or organisations, etc. Information held by the applicant or manufacturer may be protected by a confidentiality clause where it constitutes an industrial or commercial secret.

Authorisation is granted by the Member State on whose territory the product is placed on the market for the first time. It is valid for ten years and may be renewed. It can be withdrawn if the requirements are no longer fulfilled and can be amended if the development of scientific and technical knowledge requires.

To ensure the free circulation of products, the Directive provides for mutual recognition of authorisations granted by the Member States, provided that the plant health, agricultural and environmental conditions are comparable in the regions concerned. It does, however, contain a protective clause permitting Member States temporarily to restrict or prohibit the circulation of a product on their territory if it poses a risk to human or animal health or to the environment.

Every quarter, the Member States inform the Commission and the other Member States of all plant protection products authorised or withdrawn. In addition, every year Member States draw up and send to the Commission and the other Member States a list of products authorised on their territory.

Arrangements for provisional authorisation allow Member States, pending the Community’s decision to include a new active substance in the positive list, to authorise the plant protection product concerned for a maximum of three years if the dossier submitted for inclusion of the active substance and the dossier for the authorisation of the plant protection product are in order and if it is established that the active substance and the product pose no risk.

As regards active substances currently on the market, the Directive provides for an evaluation programme for these substances over a period of 12 years from the entry into force of the Directive. This programme was extended until March 2009. Since the end of 2003, the European Food Safety Authority has been responsible for assessing risks, while the Commission is still responsible for taking decisions concerning risk management.

The Directive also harmonises the rules on the labelling and packaging of plant protection products and the information they must bear, among other things, the name and designation of the product, the name and address of the holder of the authorisation, the quantity of each active substance, the directions for use, the dose for each authorised use and particulars of possible phytotoxicity, etc.

Context

This Directive is repealed with effect from 14 June 2011 by Regulation (EC) No 1107/2009 on the placing on the market of plant protection products.

Key terms used in the act
  • Plant protection products: these are products consisting of, or containing, active substances, safeners or synergists, intended for one of the following uses:
    • protecting plants or plant products against all harmful organisms or preventing the action of such organisms, except if they are mainly designed for reasons of hygiene rather than protection of vegetables or vegetable products;
    • influencing the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
    • preserving plant products, in so far as such substances or products are not subject to Community provisions on preservatives;
    • destroying undesirable plants, or parts thereof, with the exception of algae;
    • checking or preventing undesired growth of plants, except algae.
  • Active substances: substances or micro-organisms, including viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products.

References

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

Directive 91/414//EEC

26.7.1991 (notification)

26.7.1993

OJ L 230 of 19.8.1991

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

Regulation (EC) No 806/2003

5.6.2003

OJ L 122 of 16.5.2003

Regulation (EC) No 396/2005

5.4.2005

OJ L 70 of 16.3.2005

AMENDMENT OF ANNEXES

Annex I – Active substances authorised for use in plant protection products:

Directive 2000/80/EC (lambda-cyhalothrin) [Official Journal L 309 of 9.12.2000];
Directive 2001/21/EC (amitrole, diquat, pyridate and thiabendazole) [Official Journal L 69 of 10.3.2001];
Directive 2001/28/EC (fenhexamid) [Official Journal L 113 of 24.4.2001];
Directive 2001/47/EC (paecilomyces fumosoroseus) [Official Journal L 175 of 28.6.2001];
Directive 2001/49/EC (flupyrsulfuron-methyl) [Official Journal L 176 of 29.6.2001];
Directive 2001/87/EC (acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl) [Official Journal L 276 of 19.10.2001];
Directive 2001/99/EC (glyphosate and thifensulfuron-methyl) [Official Journal L 304 of 21.11.2001];
Directive 2001/103/EC (2,4-dichlorophenoxy acetic acid) [Official Journal L 313 of 30.11.2001];
Directive 2002/18/EC (isoproturon) [Official Journal L 55 of 26.2.2002];
Directive 2002/37/EC (ethofumesate) [Official Journal L 117 of 4.5.2002];
Directive 2002/48/EC (iprovalicarb, prosulfuron and sulfosulfuron) [Official Journal L 148 of 6.6.2002];
Directive 2002/64/EC (cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl-M and picolinafen) [Official Journal L 189 of 18.7.2002];
Directive 2002/81/EC (flumioxazine) [Official Journal L 276 of 12.10.2002];
Directive 2003/5/EC (deltamethrin) [Official Journal L 8 of 14.1.2003];
Directive 2003/23/EC (imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid) [Official Journal L 81 of 28.3.2003];
Directive 2003/31/EC (2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin) [Official Journal L 101 of 23.4.2003];
Directive 2003/39/EC (propineb and propyzamide) [Official Journal L 124 of 20.5.2003];
Directive 2003/68/EC (trifloxystrobin, carfentrazone ethyl, mesotrione, fenamidone and isoxaflutole) [Official Journal L 177 of 16.7.2003];
Directive 2003/70/EC (mecoprop, mecoprop-P and propiconazole) [Official Journal L 184 of 23.7.2003];
Directive 2003/79/EC (coniothyrium minitans) [Official Journal L 205 of 14.8.2003];
Directive 2003/81/EC (molinate, thiram and ziram) [Official Journal L 224 of 6.9.2003];
Directive 2003/84/EC (flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam) [Official Journal L 247 of 30.9.2003];
Directive 2003/112/EC (paraquat) [Official Journal L 321 of 6.12.2003];
Directive 2003/119/EC (mesosulfuron, propoxycarbazone and zoxamide) [Official Journal L 325 of 12.12.2003];
Directive 2004/20/EC (chlorpropham) [Official Journal L 70 of 9.3.2004];
Directive 2004/30/EC (benzoic acid, flazasulfuron and pyraclostrobin) [Official Journal L 77 of 13.3.2004];
Directive 2004/58/EC (alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham) [Official Journal L 120 of 24.4.2004];
Directive 2004/60/EC (quinoxyfen) [Official Journal L 120 of 24.4.2004];
Directive 2004/62/EC (mepanipyrim) [Official Journal L 125 of 28.4.2004];
Directive 2004/71/EC (Pseudomonas chlororaphis) [Official Journal L 127 of 29.4.2004];
Directive 2004/99/EC (acetamiprid and thiacloprid [Official Journal L 309 of 6.10.2004];
Directive 2005/2/EC (Ampelomyces quisqualis and Gliocladium catenulatum) [Official Journal L 20 of 22.1.2005];
Directive 2005/3/EC (imazosulfuron, laminarin, methoxyfenozide and s-metolachlor) [Official Journal L 20 of 22.1.2005];
Directive 2005/34/EC (etoxazole and tepraloxydim) [Official Journal L 125 of 18.5.2005];
Directive 2005/53/EC (chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl) [Official Journal L 241 of 17.9.2005];
Directive 2005/54/EC (tribenuron) [Official Journal L 244 of 20.9.2005];
Directive 2005/57/EC (MCPA and MCPB) [Official Journal L 246 of 22.9.2005];
Directive 2005/58/EC (bifenazate and milbemectin) [Official Journal L 246 of 22.9.2005];
Directive 2005/72/EC (chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram) [Official Journal L 279 of 22.10.2005];
Directive 2006/5/EC (warfarin) [Official Journal L 12 of 18.1.2006];
Directive 2006/6/EC (tolylfluanid) [Official Journal L 12 of 18.1.2006];
Directive 2006/10/EC (forchlorfenuron and indoxacarb) [Official Journal L 25 of 28.1.2006];
Directive 2006/19/EC (1-methylcyclopropene) [Official Journal L 44 of 15.2.2006];
Directive 2006/39/EC (clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole) [Official Journal L 104 of 13.4.2006];
Directive 2006/41/EC (clothianidin and pethoxamid) [Official Journal L 187 of 8.7.2006];
Directive 2006/45/EC (propoxycarbazone) [Official Journal L 130 of 18.5.2006];
Directive 2006/64/EC (clopyralid, cyprodinil, fosetyl and trinexapac) [Official Journal L 206 of 27.7.2006];
Directive 2006/74/EC (dichlorprop-P, metconazole, pyrimethanil and triclopyr) [Official Journal L 235 of 30.8.2006];
Directive 2006/75/EC (dimoxystrobin) [Official Journal L 248 of 12.9.2006];
Directive 2006/85/EC (fenamiphos and ethephon) [Official Journal L 293 of 24.10.2006];
Directive 2006/131/EC (methamidophos) [Official Journal L 349 of 12.12.2006];
Directive 2006/132/EC (procymidone) [Official Journal L 349 of 12.12.2006];
Directive 2006/133/EC(flusilazole) [Official Journal L 349 of 12.12.2006];
Directive 2006/134/EC (fenarimol) [Official Journal L 349 of 12.12.2006];
Directive 2006/135/EC (carbendazim) [Official Journal L 349 of 12.12.2006];
Directive 2006/136/EC (dinocap) [Official Journal L 349 of 12.12.2006];
Directive 2007/5/EC (captan, folpet, formetanate and methiocarb) [Official Journal L 35 of 8.2.2007];
Directive 2007/6/EC (metrafenone, Bacillus subtilis , spinosad and thiamethoxam) [Official Journal L 43 of 15.2.2007];
Directive 2007/21/EC (azoxystrobin, imazalil, kresoxim-methyl, spiroxamin, azimsulfuron, prohexadion-calcium and fluroxypyr) [Official Journal L 97 of 12.4.2007];
Directive 2007/25/EC (dimethoate, dimethomorph, glufosinate, metribuzin, phosmet and propamocarb as active substances) [Official Journal L 106 of 24.4.2007];
Directive 2007/31/EC (fosthiazate) [Official Journal L 140 of 1.6.2007];
Directive 2007/50/EC (beflubutamid and Spodoptera exigua nuclear polyhedrosis virus) [Official Journal L 202 of 3.8.2007];
Directive 2007/52/EC (ethoprophos, pirimiphos-methyl and fipronil) [Official Journal L 214 of 17.8.2007];
Directive 2007/76/EC (fludioxonil, clomazone and prosulfocarb) [Official Journal L 337 of 21.12.2007];
Directive 2008/40/EC (amidosulfuron and nicosulfuron) [Official Journal L 87 of 29.3.2008];
Directive 2008/41/EC (chloridazon) [Official Journal L 89 of 1.4.2008];
Directive 2008/45/EC (metconazole) [Official Journal L 94 of 5.4.2008].
Directive 2008/66/EC (bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine) [Official Journal L 171 of 1.1.2008].
Directive 2008/69/EC (clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen) [Official Journal L 172 of 2.7.2008];
Directive 2008/70/EC (tritosulfuron) [Official Journal L 185 of 12.7.2008];
Directive 2008/91/EC (diuron) [Official Journal L 262 of 1.10.2008];
Directive 2008/107/EC (abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim) [Official Journal L 316 of 26.11.2008];
Directive 2008/108/EC (flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat) [Official Journal L 317 of 27.11.2008];
Directive 2008/113/EC (several micro-organisms) [Official Journal L 330 of 9.12.2008];
Directive 2008/116/EC (aclonifen, imidacloprid and metazachlor) [Official Journal L 337 of 16.12.2008];
Directive 2008/125/EC (aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol) [Official Journal L 344 of 20.12.2008];
Directive 2008/127/EC (several active substances) [Official Journal L 344 of 20.12.2008];
Directive 2009/11/EC (bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad) [Official Journal L 48 of 19.2.2009];
Directive 2009/25/EC (pyraclostrobin) [Official Journal L 91 of 3.4.2009];
Directive 2009/37/EC (chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin) [Official Journal L 104 of 24.4.2009];
Directive 2009/51/EC (nicosulfuron) [Official Journal L 127 of 26.5.2009];
Directive 2009/70/EC (difenacoum, didecyldimethylammonium chloride and sulphur) [Official Journal L 164 of 26.6.2009];
Directive 2009/77/EC (chlorsulfuron, cyromazine, dimethachlor, etofenprox, lufenuron, penconazole, tri-allate and triflusulfuron) [Official Journal L 172 of 2.7.2009];
Directive 2009/82/EC (tetraconazole) [Official Journal L 196 of 28.7.2009];
Directive 2009/115/EC (methomyl) [Official Journal L 228 of 1.9.2009];
Directive 2009/116/EC (paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3) [Official Journal L 237 of 9.9.2009];
Directive 2009/117/EC (paraffin oil CAS No 8042-47-5 [Official Journal L 237 of 9.9.2009];
Directive 2009/152/EC (carbendazim) [Official Journal L 314 of 1.12.2009];
Directive 2009/153/EC (hydrolysed proteins) [Official Journal L 314 of 1.12.2009];
Directive 2009/154/EC (cyflufenamid) [Official Journal L 314 of 1.12.2009];
Directive 2009/155/EC (metazachlor) [Official Journal L 314 of 1.12.2009];
Directive 2009/160/EU (2-phenylphenol) [Official Journal L 338 of 19.12.2009].

Annex II – Requirements for the dossier to be submitted for the inclusion of an active substance in Annex I:

Directive 93/71/EEC [Official Journal L 221 of 31.8.1993];
Directive 94/37/EC [Official Journal L 194 of 29.7.1994];
Directive 94/79/EC [Official Journal L 354 of 31.12.1994];
Directive 95/35/EC [Official Journal L 172 of 22.7.1995];
Directive 95/36/EC [Official Journal L 172 of 22.7.1995];
Directive 96/12/EC [Official Journal L 65 of 15.3.1996];
Directive 96/46/EC [Official Journal L 214 of 23.8.1996];
Directive 96/68/EC [Official Journal L 277 of 30.10.1996];
Directive 2001/36/EC [Official Journal L 164 of 20.6.2001].

Annex III – Requirements for the dossier to be submitted for the authorisation of a plant protection product:

Directive 93/71/EEC [Official Journal L 221 of 31.8.1993];
Directive 94/37/EC [Official Journal L 194 of 29.7.1994];
Directive 94/79/EC [Official Journal L 354 of 31.12.1994];
Directive 95/35/EC [Official Journal L 172 of 22.7.1995];
Directive 95/36/EC [Official Journal L 172 of 22.7.1995];
Directive 96/12/EC [Official Journal L 65 of 15.3.1996];
Directive 96/46/EC [Official Journal L 214 of 23.8.1996];
Directive 96/68/EC [Official Journal L 277 of 30.10.1996];
Directive 2001/36/EC [Official Journal L 164 of 20.6.2001].

Annex IV – Risk phrases:

Directive 2006/104/EC [Official Journal L 363 of 20.12.2006].

Annex V – Safety phrases:

Directive 2006/104/EC [Official Journal L 363 of 20.12.2006].

Annex VI – Uniform principles for the evaluation and authorisation of plant protection products:

Directive 97/57/EC [Official Journal L 265 of 27.9.1997];
Directive 2005/25/EC [Official Journal L 90 of 8.4.2005].

Related Acts

Programme for the evaluation of existing substances

Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I [Official Journal L 15 of 18.1.2008].
This Regulation completes the programme of work on the gradual examination of active substances on the market and lays down rules for the submission and evaluation of applications for inclusion in Annex I to Directive 91/414/EEC. Two procedures are established: a regular procedure involving verification by the Member State of dossiers on the active substance concerned, and an accelerated procedure which can be followed in the case of non-inclusion of the active substance.

Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 379 of 24.12.2004].

Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 168 of 27.6.2002].

Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 55 of 29.2.2000].

Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market [Official Journal L 366 of 15.12.1992].

This Regulation lays down detailed rules governing the relationship between industry, the Member States and the Commission for the implementation of the first phase of the programme, covering an initial series of 90 active substances.

Plant protection products prohibited

Plant protection products prohibited

Outline of the Community (European Union) legislation about Plant protection products prohibited

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

Plant protection products prohibited (until June 2011)

The European Union regulates the placing on the market and use of plant protection products and lists the prohibited active substances.

Document or Iniciative

Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances [See amending acts].

Summary

The purpose of this Directive is to prohibit the placing on the market and use of plant protection products * containing certain active substances *.

This Directive, and its subsequent amendments, include an annexed list of the active substances that may be neither placed on the market nor used. However, temporary derogations may be granted at national level for specific uses.

Active substances are included in the Annex if their use gives rise, or is likely to give rise, to harmful effects on human or animal health or to unacceptable adverse effects on the environment.

Where an unforeseeable danger threatens plant production and cannot be contained by other means, the Member State in question may permit the placing on the market and the use of the product for a maximum period of 120 days.

The Directive does not apply to plant protection products to be used for research or analysis, or exported to a third country.

Context

As of 14 June 2011, this Directive is repealed by Regulation (EC) No 1107/2009 regarding the placing of plant protection products on the market.

Key terms used in the act
  • Plant protection products: active substances and preparations containing one or more active substances which do one or more of the following:
    a) protect plants or plant products against all harmful organisms or prevent the action of such organisms;
    b) influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
    c) preserve plant products, in so far as such substances or products are not subject to special provisions on preservatives;
    d) destroy undesirable plants or
    e) destroy parts of plants, check or prevent undesired growth of plants.
  • Active substances: substances or micro-organisms including viruses having general or specific action against harmful organisms or on plants, parts of plants or plant products.

References

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

Directive 79/117/EEC

22.12.1978

1.1.1981

OJ L 33 of 08.02.1979

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

Directive 86/214/EEC

4.6.1986

OJ L 152 of 6.6.1986

Regulation (EC) No 807/2003

5.6.2003

OJ L 122 of 16.5.2003

AMENDMENTS TO THE ANNEX

Annex – List of prohibited active substances and derogations

Directive 83/131/EEC [Official Journal L 91 of 9.4.1983];
Directive 85/298/EEC [Official Journal L 154 of 13.6.1985];
Directive 86/355/EEC [Official Journal L 212 of 2.8.1986];
Directive 87/181/EEC [Official Journal L 71 of 14.3.1987];
Directive 87/477/EEC [Official Journal L 273 of 26.9.1987];
Directive 89/365/EEC [Official Journal L 159 of 10.6.1989];
Directive 90/335/EEC [Official Journal L 162 of 28.6.1990];
Directive 90/533/EEC [Official Journal L 296 of 27.10.1990];
Directive 91/188/EEC [Official Journal L 92 of 13.4.1991];
Regulation (EC) No 850/2004 [Official Journal L 158 of 30.4.2004].

Maximum pesticide limits for food products for human consumption and animal feedingstuffs

Maximum pesticide limits for food products for human consumption and animal feedingstuffs

Outline of the Community (European Union) legislation about Maximum pesticide limits for food products for human consumption and animal feedingstuffs

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

Maximum pesticide limits for food products for human consumption and animal feedingstuffs

Document or Iniciative

Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC [See amending acts].

Summary

The Regulation establishes the maximum quantities of pesticide residues permitted in products of animal or vegetable origin intended for human or animal consumption. These maximum residue levels * (MRLs) include, on the one hand, MRLs which are specific to particular foodstuffs intended for human or animal consumption and, on the other, a general limit which applies where no specific MRL has been set.

The objective is to ensure that pesticide residues in foodstuffs do not constitute an unacceptable risk for consumer and animal health.

Foodstuffs concerned

The Regulation covers all products intended for human or animal consumption listed in Annex I.

These products are not subject to the set limits if they are intended for sowing or planting, authorised tests on active substances, manufacture of non-food products, or export outside the European Union.

Default limit and specific limits

The maximum pesticide residue level in foodstuffs is 0.01 mg/kg. This general limit is applicable ‘by default’, i.e. in all cases where an MRL has not been specifically set for a product or product type.
Some of the specific MRLs listed in Annex II are higher than the default limit.

In some cases, provisional MRLs may be set and should then be listed in Annex III. Provisional MRLs should in particular be set in the following cases:

  • for honey and herbal infusions;
  • in certain exceptional circumstances of contamination by plant protection products;
  • for national MRLs which have not yet been harmonised;
  • where new products are listed in Annex I and a Member State requests it, in order to have enough time for a comprehensive scientific assessment and provided that no risk to the consumer has been detected.

Products which do not comply with the fixed limits may not be diluted except in the case of certain processed and/or composite products listed by the Commission (Annex VI).

Exceptions to the limits

Certain substances listed by the Commission (Annex VII) may be authorised even if they exceed their MRL, if they meet the following conditions:

  • the products concerned are not intended for immediate consumption;
  • controls are in place to ensure that these products are not made available to the consumer;
  • the other Member States and the Commission are informed of the measures.

In exceptional cases, products which do not comply with the limits set in Annexes I and II may be authorised by a Member State if the products do not represent an unacceptable risk. The Member State must immediately inform the Commission, the other Member States and the European Food Safety Authority (EFSA) so that the appropriate measures may be taken as quickly as possible (provisional MRL, etc.).

Certain active substances are not subject to any residue limit. These are the active substances present in the plant protection products assessed pursuant to Directive 91/414/EEC (on the placing of plant protection products on the market) and for which no MRL was considered necessary. They are listed in Annex IV, which the Commission is to draw up within 12 months of the entry into force of this Regulation.

Setting, amending and removing MRLs

For a plant protection product to be placed on the market pursuant to Directive 91/414/EEC, the active substances which it contains should be assessed in order to determine the threshold above which their concentration in food products presents a risk for humans and animals.

This Regulation establishes the procedure for MRL applications. Such applications must be submitted to the Member State, which communicates them to the European Food Safety Authority (EFSA).

Risk assessment is the responsibility of the EFSA, which decides on each intended new MRL, amendment or removal (except in the case of removals resulting from an authorisation of a plant protection product being revoked). The EFSA issues an opinion including the anticipated limit of determination * for the pesticide/commodity combination, and a risk assessment for cases where the admissible daily intake is exceeded.

Based on the EFSA’s opinion, the Commission issues a Regulation to establish a new MRL or to amend or remove an existing MRL.

Checking of MRLs

Based on Community and national multi-annual programmes updated every year, the Member States carry out checks on pesticide residues to ensure compliance with the MRLs. These checks entail taking samples, analysing them and identifying the pesticides and respective pesticide levels present therein.

Context

Prior to this Regulation, each Member State applied its own maximum residue limits for pesticides. Previous European legislation set different limits for different kinds of product: fruit and vegetables (Directive 76/895/EEC), cereals (Directive 86/362/EEC), foodstuffs of animal origin (Directive 86/363/EEC) and plant products, including fruit and vegetables (Directive 90/642/EEC). This Regulation repeals all these Directives, proposing harmonised maximum limits for all foodstuffs instead. It includes the same level of protection for animal feedingstuffs. It is the first time that a common limit of this type is established at European level for all types of pesticide, without distinguishing between categories of food.

The use of active substances in plant protection products is one of the best methods of protecting vegetables from harmful organisms. This use can, however, cause residues to be present in treated products, in animals fed with those products and in honey produced by bees exposed to these substances. Care should therefore be taken to ensure that levels of these residues do not present unacceptable risks for human beings and, where appropriate, for animals.

The Standing Committee on the Food Chain and Animal Health helps the Commission to reach decisions on the maximum limits applicable to pesticide residues. In the Member States, the designated national authorities manage contacts with the Commission, the EFSA, the other Member States and all the stakeholders affected by this Regulation.

Key terms used in the act

Maximum residue limit: maximum permitted concentration of the residue of a pesticide in or on foodstuffs for humans or animals;

Limit of determination: weakest concentration of residue that can be measured and recorded by a routine check using suitable methods.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 396/2005

5.4.2005

OJ L 70 of 16.3.2005

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 178/2006

22.2.2006

OJ L 29 of 2.2.2006

Regulation (EC) No 149/2008

1.9.2008

OJ L 58 of 1.3.2008

Regulation (EC) No 260/2008

8.4.2008

OJ L 76 of 19.3.2008

Regulation (EC) No 299/2008

10.4.2008

OJ L 97 of 9.4.2008

Regulation (EC) No 839/2008

31.8.2008

OJ L 234 of 30.8.2008

Regulation (EC) No 256/2009

28.3.2009

OJ L 81 of 27.3.2009

The successive amendments and corrections to Regulation (EEC) No 396/2005 have been incorporated into the basic text. This consolidated versionhas only documentary value.

Related Acts

Commission Regulation (EU) No 915/2010 of 12 October 2010 concerning a coordinated multiannual control programme of the Union for 2011, 2012 and 2013 to ensure compliance with maximum levels of and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin [Official Journal L 269 of 13.10.2010].

Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [Official Journal L 165 of 30 April 2004].

Directive 2002/63/EC establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin [Official Journal L 187 of 16 July 2002].

Towards a thematic strategy on the sustainable use of pesticides

Towards a thematic strategy on the sustainable use of pesticides

Outline of the Community (European Union) legislation about Towards a thematic strategy on the sustainable use of pesticides

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

Towards a thematic strategy on the sustainable use of pesticides

The Commission lays the foundations for a thematic strategy to reduce the impacts of pesticides on human health and the environment and, more generally, to achieve a more sustainable use of pesticides as well as a significant overall reduction in the risks and uses of pesticides consistent with the necessary crop protection.

Document or Iniciative

Communication of 1 July 2002 from the Commission to the Council, the European Parliament and the Economic and Social Committee – Towards a thematic strategy on the sustainable use of pesticides [COM(2002) 349 final -Not published in the Official Journal].

Summary

Background

1. The 6th environment action programme (6th EAP), adopted by the European Parliament and the Council on 22 July 2002, provides for the development of a thematic strategy on the sustainable use of pesticides.

The legislative framework referred to in the 6th EAP, in particular Directive 91/414/EEC and the Directives on residues in food, mainly concentrates on the start and end-of-life stages of pesticides, i.e. the authorisation of substances for use in plant protection products (PPP) before they are placed on the market (prevention at source) and maximum residue levels (MRLs) for food and feedstuffs. Revision of these Directives is under way.

The thematic strategy will therefore complement the existing legislative framework by targeting the use-phase of plant protection products.

Definitions and scope of the communication

2. The term “pesticides” is a generic name, which encompasses all substances or products that kill pests. In this connection, a distinction should be made between:

  • plant protection products: these are active substances and preparations containing one or more active substances that are used to protect plants or plant products against harmful organisms or prevent the action of such organisms. PPPs are used in particular in agriculture; and
  • biocides. These are active substances and preparations containing one or more active substances that are used in non-agricultural sectors, e.g. for purposes such as wood preservation, disinfection or certain household uses.

3. It is clear from the decision of the European Parliament and the Council adopting the 6th EAP that, although the term “pesticides” is used, the main concerns are related to PPPs. Consequently, the communication is focused on the use of PPPs. Should, in the future, comparable measures be considered necessary for biocides, they will be incorporated in the thematic strategy.

Use of PPPs quantities, benefits, costs and risks of using them

4. Quantity. Agriculture is by far the biggest PPP-using sector. With approximately 320 000 tonnes of active substances sold per year, the European Union currently accounts for one quarter of the world market of PPPs. The major types of product are fungicides (ca 43% of the market), followed by herbicides (36%), insecticides (12%) and other pesticides (9%). The European PPP producing industry is a major employer in Europe (around 35 000 workers).

5. Advantages. There are significant economic benefits associated with the use of PPPs. They are used by farmers to improve or safeguard yields by eliminating or reducing competition from weeds and attacks by pests and to minimise labour input. PPPs also play an essential role in ensuring reliable supplies of agricultural products each year at prices which make them affordable for all consumers. The use of PPPs also reduces demand for land for food production. It therefore makes land available for other uses, e.g. amenity, nature parks or protection of biodiversity. There are however no figures available for the whole of the EU on which to base an evaluation of these benefits.

6. Risks and costs associated with their use. Pesticides are chemicals that require particular attention because most of them have inherent properties that make them dangerous to health and the environment.

The risks for human and animal health stem from the extreme toxicity of certain PPPs. They may occur through direct exposure (industrial workers producing pesticides and operators using them) or indirect exposure (consumers and bystanders). The chronic effects of exposure to PPPs which might affect the fitness of exposed populations include those due to bioaccumulation and persistence of substances, irreversible effects such as carcinogenicity, mutagenicity and genotoxicity or adverse effects on the immune or endocrine systems of mammals, fishes or birds.

As regards risks for the environment, spray drift, leaching or run-off are diffuse sources of uncontrolled dissemination of PPPs into the environment leading to pollution of soil and water. PPP use may also have additional indirect effects on ecosystems, e.g. loss of biodiversity. In practice it is extremely difficult to quantify the actual adverse effects resulting from the use of pesticides. Therefore, it is not possible to give a figure for the overall costs of the use of pesticides in the EU.

Objectives of the thematic strategy

7. The communication represents an important step in the preparation of the thematic strategy on sustainable use of pesticides. The objectives fixed by the Council and Parliament are presented below: the communication suggests ways and means of achieving each objective, with a view to initiating discussion at this stage of the consultation:

8. Objective 1. Minimising the hazards and risks to health and environment from the use of pesticides, through:

  • establishment of national plans to reduce hazards, risks and dependence on chemical control;
  • reducing particular risks, such as pollution of watercourses, ditches and water catchment areas and the introduction of chemical control measures in environmentally sensitive areas;
  • improving knowledge of risks by monitoring the health of users at particularly high risk, such as agricultural workers and more sensitive consumers; collection of data on incidents having consequences for the health and environment of workers and private users; collection and analysis of economic data on PPP use and alternatives;
  • further research and development work on less hazardous methods of application and handling of PPPs.

9. Objective 2. Improved controls on the use and distribution of pesticides:

  • reporting of production and import/export quantities of PPPs by producers and distributors to national authorities;
  • reinforcement of ongoing work on the collection of data concerning use (quantities of PPPs applied per crop, product, area, date of application, etc.);
  • reinforcement of the system based on Article 17 of Directive 91/414/EEC (inspections, monitoring of use and distribution of PPP by wholesalers, retailers and farmers) in a coordinated way;
  • introduction of a system of regular and safe collection, possible reuse and controlled destruction of PPP packaging and unused products;
  • introduction of a system of regular technical inspection of application equipment (sprayers);
  • creation of a system of mandatory education, awareness raising, training and certification for all PPP users (farmers, local authorities, workers, distributors, traders and extension services).

10. Objective 3. Reducing the levels of harmful active substances by replacing the most dangerous with safer (including non chemical) alternatives: This objective will be achieved basically through faster implementation of Directive 91/414/EEC, in particular through its programme of reevaluating old active substances and through the introduction of this principle in the text of the Directive itself as a result of its revision, planned in the near future.

11. Objective 4. Encouragement of the use of low input or pesticide-free crop farming particularly by raising users’ awareness, promoting the use of codes of good practices and consideration of the possible application of financial instruments:

  • promotion and development of alternatives to chemical control; examining the potential of the use of GM technology when its application is considered as safe for health and the environment; promoting good practices by further developing codes of good farming practice incorporating integrated pest management concepts; further encouraging the allocation of funds by Member States and the adoption by farmers of rural development measures and training and other relevant measures;
  • imposing penalties on users by reducing or cancelling benefits under support schemes;
  • introducing special levies on PPPs to raise awareness of the detrimental effects of over-intensive PPP use and further reduce reliance on chemical inputs in modern agriculture;
  • harmonisation of the value added tax rates for PPPs (these vary between 3% and 25% in the various Member States).

12. Objective 5. A transparent system for reporting and monitoring the progress made, including the development of suitable indicators:

  • regular reporting on national risk reduction programmes;
  • development of suitable indicators for monitoring and definition of quantitative targets.

Candidate countries

13. The management of stockpiles of obsolete pesticides in a number of candidate countries has been mentioned repeatedly as an important problem in the context of EU enlargement. Sizeable quantities of pesticides still in use in several candidate countries might become obsolete at the moment of accession. In addition, there are already considerable stocks of obsolete pesticides at the moment. If no appropriate measures are taken, candidate countries might not have adequate incinerators which respect the required emission limits; this will necessitate upgrading of incineration facilities or require transport of pesticides. A proportion of the obsolete pesticides will be covered by the Stockholm Convention on persistent organic pollutants (POPs) but there will probably be a need for further support for the candidate countries.

International aspects

14. The Community and the Member States should contribute to the safe use of PPPs in developing countries and the newly independent States (NIS) by better monitoring and assessing their exports and donations of chemicals, training and stewardship of the use, handling and storage of PPPs and the management of stockpiles of obsolete PPPs, by supporting capacity building and information exchange. Full implementation of the Rotterdam (PIC – prior informed consent) and Stockholm (POPs) Conventions will be major steps in that direction. It also includes strengthening the integration of environmental objectives into development policy and contributing to the achievement of the objectives of the Intergovernmental Forum on Chemical Safety.

Implementation of the strategy

15. On the basis of the analyses developed in the communication and the outcome of the consultation process currently under way, the Commission will propose at the beginning of 2004 all necessary measures setting out a Community thematic strategy on the sustainable use of pesticides.

16. The Community and the Member States, in implementing such a strategy, could use many different instruments: legally binding measures, economic incentives, research or voluntary measures. Combination of all types of instruments is also possible. Many of these measures could most effectively be integrated into already existing or currently developing related policy areas, such as water protection, health and consumer protection and the common agricultural policy.

Related Acts

Commission Communication of 12 July 2006 entitled ” A Thematic Strategy on the Sustainable Use of Pesticides ” [

COM(2006) 372

final – not published in the Official Journal].
The strategy comprises, firstly, measures which are incorporated in existing legislative instruments and current policies and, secondly, measures which cannot be incorporated in existing instruments and are the subject of a proposal for a Directive presented in parallel. The measures are intended to meet the five objectives identified above in the 2002 communication.

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