E.U. Regulatory Watch

Originally published March 2004

Contents:

Chemicals

Pesticides/Biocides

Life Sciences

Food

Environment General Issues

Energy

Consumers/Safety/Intellectual Property

Institutional Issues

Chemicals

Rotterdam Convention

On February 24, the Convention on Prior Informed Consent (PIC) procedure for the international trade of hazardous chemicals and pesticides entered into force. The Convention had already been transposed in the Community legal order by Regulation 304/2003 of January 28, 2003 concerning the export and import of dangerous chemicals.

Persistent Organic Pollutants-First Reading

On February 26, the European Parliament adopted its First Reading position on the Commission proposal for a Regulation on persistent organic pollutants and amending Directives 79/117/EEC and 96/59/EC.

The European Parliament amendments aim to prevent the production, placing on the market and use of new chemicals and pesticides which exhibit characteristics of POPs according to Annex D to the Convention. The Parliament position pays specific attention to waste contamination and isolation of dangerous substances. It prohibits the re-use, recycling or recovery of contaminated waste and it creates a Committee for waste matters. The Parliament also introduces an exemption for the continued use of DDT as close-system site-limited intermediate and for HCH in professional and industrial uses; these exemptions will be applicable within specific deadlines. Furthermore, the Parliament adopted so-called "name and shame" amendments which require the information on infringements and name of contravening companies to be published. This position has been adopted after informal discussions with the Council in a way to secure a first reading agreement.

On February 19, the Council adopted a Decision concerning the conclusion, on behalf of the European Community, of the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on POPs.

(Ref: COM(2003)333 and Decision 2004/259)

Marketing Restrictions on PAH

On February 16, the Commission adopted a proposal for a Directive on restrictions on the marketing and use of certain polycyclic aromatic hydrocarbons (PAH) in extender oils and tyres (27th amendment of Council Directive 76/769/EEC). The Commission presented its proposal after the CSTEE confirmed the scientific findings which identified the adverse health effects of PAHs. In addition, the proposal aims to contribute to the reduction of total annual emissions of PAHs as required in the 1998 Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants.

(Ref.: COM(2004)98 / IP/04/208)

Critical Uses of Ozone-Depleting Substances

On January 28, the Commission adopted a Decision amending Regulation (EC) No 2037/2000 on substances that deplete the ozone layer. It allocates the quantities of controlled substances allowed for essential uses in the Community in 2004. The exemptions are applicable to those companies listed and for the identified essential medical or laboratory uses only.

(Ref.: Commission Decision 2004/209/EC)

On March 3, the Commission also adopted a Decision amending Regulation (EC) No 2037/2000 on substances that deplete the ozone layer. It grants critical-use exemptions to Acceding Countries for the uses of halon 2402 listed in the Annex.

(Ref.: Commission Decision 2004/232/EC)

European Pollutant Emission Register

On February 23, the Commission and the European Environment Agency launched the European Pollutant Emission Register (EPER) and its website: www.eper.cec.eu.int. The EPER is created in the framework of the IPPC Directive (Directive 96/61/EC), under Decision 2000/479. It contains Member States data on emissions collected as of 2001.

(Ref.: IP/04/249)

Azo-Colorants

On February 24, the Commission adopted a Directive incorporating harmonized test standards for testing and detecting azo-colorants into Annex I to Directive 76/769/EEC, in the implementation of Directive 2002/61/EC.

(Ref.: Commission Directive 2004/21/EC)

Detergents

On March 11, the Competitiveness Council formally adopted the compromise Second Reading Position reached by the European Parliament on January 13.

The future Regulation will replace, update and consolidate the existing legislation (Ref: Council Directive 73/404/EEC on detergents; Council Directive 73/405/EEC relating to methods of testing the biodegradability of anionic surfactants; Council Directive 82/242/EEC on methods of testing the biodegradability of non-ionic surfactants).

The compromise text clarifies the conditions for granting derogations and allows Member States to lay down or maintain national rules on the use of phosphates. The Commission must submit a proposal on a ban of phosphate within three years from the entry into force of the Regulation.

On February 27, the Commission also published a report on Good Environmental Practice for Household Laundry Detergents pursuant to Article 9 of Commission Recommendation 98/480/EC of 22 July 1998.

(Ref.: COM(2004)134)

Good Laboratory Practice

On February 11, the European Parliament and Council adopted two Directives on good laboratory practice (GLP). The First one concerns the inspection and verification of GLP and the second one is a codified version of the application of the principles of GLP and the verification of their application for tests on chemical substances. The Directives repeal Council Directive 87/18/EEC and Commission Directive 1999/11/EC.

(Ref.: Directives 2004/9/EC and 2004/10/EC)

Azodicarbonamide as Blowing Agent

On January 6, the Commission adopted a Directive which amends Directive 2002/72/EC and suspends the use of azodicarbonamide as a 'blowing agent'. Azodicarbonamide is used in the manufacture of plastic gaskets in metal lids used for closure of glass jars, including those used in food. It has been shown to decompose under heat to semicarbazide (SEM), which may have weak carcinogenic activity. SEM has been detected at up to 25g/kg in baby foods. The Directive must be transposed in national legislation by August 2005.

(Ref. Commission Directive 2004/1/EC)

Transport of Dangerous Good by Road

On January 26, the Commission published, according to Directive 2001/7, the third adaptation to technical progress of Annexes A and B to Directive 94/55/EC on the transport of dangerous good by road.

(Ref.: O.J. L18/1)

Pesticides/Biocides

France Bans PPP Containing Fipronil, Possibly Linked to Bee Mortality

On February 23, the French Ministry for Agriculture suspended the marketing of all plant protection products containing the active substance "fipronil". The ban will be in force until the European evaluation procedure is completed, which is due by December 31, 2005. Farmers are however allowed to use their current stocks during the upcoming planting.

France, as the Rapporteur Member State (RMS) under the Community scheme for evaluation of existing plant protection products, has sent to the European Food Safety Authority its report proposing that fipronil should not be listed in Annex I to Directive 91/414/EC, because the information available leaves some uncertainty as regards the behavior of the active substance in the environment, notably its persistence and its concentration in soils and water. Furthermore, it is said to present possible unacceptable risks for several species (particularly bees).

Previously, France had strengthened the classification of these products (imposing the most stringent classification in the EU). It had also asked its Committee on Pesticides Toxicity Evaluation to give an opinion on imidacloprid (Denmark is the designated RMS), which has the same properties as fipronil and is also denounced by beekeepers. If the Committee opinion is similar to the fipronil opinion, pesticides containing imidacloprid will be banned in France until the European evaluation procedure is concluded.

Plant Protection Products Review Progress

The Commission adopted a series of Decisions concerning the non-inclusion of simazine, atrazine, fenthion and amitraz in Annex I to Council Directive 91/414/EEC and the withdrawal...