United States: EU Regulatory Watch

• Chemicals
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On June 12, the British stakeholder forum published a list of 107 high production volume chemicals of concern (on the basis of their persistency, bioaccumulation, and toxicity). This forum is calling for more information from the industry on hazard and exposure. The Stakeholder forum will update this list regularly. The list has no regulatory or legally binding status. (Ref: DEFRA news release 209/03)

On June 16, the Commission issued a proposal for the European Union to ratify the Stockholm Convention and the UNECE protocol on Persistent Organic Pollutants (POPs) and a proposal for a Regulation implementing the obligations from the international agreements. The Convention sets prohibitions or severe restrictions for POPs, control measures as well as provisions on the widening of the initial list of 12 controlled substances to other substances to be identified as POPs. (Ref.: COM(2003)333 / IP/03/842 / IEM July)

The Council adopted, by qualified majority, a Directive amending for the 26th time Directive 76/769/EEC on the marketing and use of dangerous substances (Codecision procedure), as amended by the European Parliament at First Reading on March 27. The Portuguese delegation voted against and the Italian delegation abstained.

The initial Commission proposal was aimed at restricting the use of chromium VI in cement for manual handling, and banning nonylphenol and nonylphenol ethoxylate (NP/NPE) in eight specific areas: industrial and institutional cleaning systems; domestic cleaning; textiles and leather processing; emulsifiers in agricultural teat dips; metal working; manufacturing of pulp and paper; cosmetics including shampoos; other personal care products.

However, the adopted text tightened up the proposed measures. It now covers "co-formulants" in pesticides and biocides in the list of the eight banned uses of NP/NPE. Furthermore, the chromium VI restrictions are widened to apply in principle to all cements and the Commission is also asked to present proposals on Chromium VI restrictions for other products and an amendment to Directive 86/278/EEC to set NP/NPE limit values in sewage sludge. (Ref.: Directive 2003/53/EC / IEM July)

On June 19, the European Parliament adopted its Second Reading position on major industrial accidents hazards. The MEPs called for all forms of mining-related activities and the industrial use of potassium nitrate to be included.

On June 13, Austria and Sweden expressed to the Environment Council their will to host the future European Chemicals Agency. The Agency would be created in the framework of the future REACH system. (Ref.: Council Press release 10273/03)

On August 12, the Commission adopted a proposal for a Regulation on certain fluorinated greenhouse gases. These measures, taken in the Framework of the Kyoto Protocol objectives, aim at reducing emissions of these gases by 25% by 2010. The main sources of emissions are cooling systems, fire fighting equipment, some aerosols and some other industrial uses.

The Commission proposed, among others, provisions to improve the containment and recovery of fluorinated gases as well as marketing and use restrictions and the phasing out by 2013 of the substance HFC-134a. The Regulation shall be adopted by the Parliament and Council through the codecision procedure. (Ref.: COM(2003) 492 / IP/03/155 / IEM Sept)

On July 11, the Commission adopted a Directive approving the inclusion in Annex I to Directive 91/414/EC of the active substances trifloxystrobin, mesotrione (Rapporteur UK), carfentrazone-ethyl, fenamidone (Rapporteur France) and isoxaflutole (Rapporteur Netherlands). The Member States shall ensure that Plant Protection Products authorizations comply with this Directive by April 1, 2004. (Ref.: Directive 2003/68)

On July 17, the Commission adopted a Directive approving the inclusion in Annex I to Directive 91/414/EC of the active substances (list 1 substances) mecoprop, mecoprop-P (Rapporteur Denmark) and propiconazole (Rapporteur Finland). The Member States shall ensure that Plant Protection Products authorizations comply with this Directive by December 1, 2004. (Ref.: Directive 2003/70)

On August 13, the Commission adopted a Directive approving the inclusion in Annex I to Directive 91/414/EC of the active substance Coniothyrium Minitans (Rapporteur Germany). The Member States shall ensure that Plant Protection Products authorizations comply with this Directive by July 1, 2004. (Ref.: Directive 2003/79)

On July 25, the Commission adopted a Decision extending the time limits of 12 years set by article 8(2) for existing active substances, to 31 December 2008. The list of concerned active substances is listed in the Annex.

The Commission Regulation 1336/2003 amends Regulation 2076/2002, which listed (in its Annex II) many active substances on lists for which various Member States had requested an extension of essential uses not supported in Lists 2 and 3 of 91/414/EEC. This Regulation adds several essential use derogations, now extended to 30 June 2007. (Ref.: Decision 2003/565/EC / Regulation 1336/2003 / IEM Sept)

Commission Regulation 1044/2003 of 18 June 2003 amended Regulations 451/2000 and 1490/2002 to allow Member Sates to establish systems obliging notifiers to pay for administrative and scientific evaluation of notifications and dossiers. The fees must be used solely for the evaluation of notifications and dossiers for which that Member State is Rapporteur, and additionally where that Member State actively assists in the evaluation by other Member States.

The Commission has prepared two Decisions that are not yet listed in the Official Journal:

• The review programme to be extended to 31 December 2008 for the 146 substances supported in stage 4, unless a decision on Annex I inclusion is taken earlier, or further prescribed extensions are granted to products containing active substances unsupported in stage 4 (and a few active substances that have recently lost support in stages 2 and 3) to be withdrawn by 31 December 2003, with a use-up period to 31 December 2004.
• The second Decision lists active substances in stages 2 and 3 that have lost support since Regulation No 2076/2002 was published, plus active substances that have not been supported in stage 4 of the review (106 substances in total). Annex II to the Decision lists essential use derogations for seven of these active substances. (Ref.: Nick Leeming, TSGE - IEM July-Sept)

MRLs for unsupported active substances will be reduced to the LOD when a proposed Regulation consolidating the four existing MRLs Directives is in place. This Regulation will probably come into force in 2005 and the MRLs for unsupported active substances should not be reduced to the LOD before then. Some substantive levels will probably be set, to facilitate imports of produce from countries outside the EC. (Ref.: Nick Leeming, TSGE - IEM Sept)

On June 13, the Swedish, Finnish and Danish delegation presented their concerns during the Environment Council on a possible inclusion of the herbicide Paraquat in Annex I to Directive 91/414/EC. In this context, the Council clarified: even if this substance is added on Annex I, it "does not oblige Member States to approve products containing this substance on their territory." (Ref.: Council Press release 10273/03)

The Danish Minister for Environment has announced restrictions on the most widely used herbicide: glyphosate. From 15 September, autumn spraying of glyphosate will be banned on certain sites.

On July 22, the Council formally adopted in Second Reading the Regulations on labeling and traceability of GMOs, and on authorization and labeling of GM food and feed. These Regulations will come into force 20 days after their publication in the Official Journal.

The objective of these Regulations is to lift the 5-year-old GMO moratorium giving consumers the opportunity to choose between GMO and GM free food : foodstuffs containing more than 0.9% authorized GMOs shall bear a specific label. Products containing traces of unauthorized GMOs could remain on the market for three years if these traces are under 0.5 %.

Furthermore, on June 13, the Council adopted in Second Reading (codecision procedure) the proposed Regulation on transboundary movement of GMOs, which implements into EU law the Cartagena Protocol. The 2000 UN Cartagena Protocol on Biosafety was ratified by the EU on 27 August 2002 and will enter into force on September 11, 2003, ninety days after its 50th instrument of ratification. (Ref.: IEM July / Council Press release 10273/03)

On July 23, the Commission published guidelines for the development of strategies and best practices to ensure co-existence of GM and non-GM (conventional and organic) crops. These guidelines aim to help Member States to develop national or regional measures on the issue and propose a list of possible actions to avoid unintended presence of GMOs in non-GM crops and vice-versa.

The measures to be taken by Member States shall be proportionate, crop and region specific as well as science-based. The Commission also recommends continuous monitoring and sharing of best practices for coexistence. (Ref.: C(2003) 2624 / O.J. (2003) L 189/36 / IP/03/1096 / IEM-Sept)

On June 12, the ECJ issued a Preliminary Ruling on an Austrian MP request for access to the name of GMO manufacturers, as well as product names and penalties for inadequate labelling of GM products. The ECJ rejected the Austrian MP argument on the basis that this information did not constitute environmental data within the meaning of Directive 90/313/EEC on freedom to access to environmental information. (Ref.: Case C-316/01)

The Commission referred to the Court of Justice 11 Member States for failing to implement Directive 2001/18/EC on the deliberate release of GMOs into the environment by 17 October 2002. (Ref.: IP/03/1007)

On July 1, the UN Food Standard Agency, Codex Alimentarius Commission adopted three documents: guidelines for assessing the safety of GM food, a procedure for determining if a GM food contains new toxins or allergens, if it is altered nutritionally or exhibits unexpected effects, and a recommendation on the use of "product tracing for risk management purposes". The UN approach is closer to the European one than to the American one, and might have an impact on the outcome of the WTO case. (Ref.: IEM July)

The Government of the United States, along with Canada and Argentina, challenged the moratorium in front of the WTO and called for a dispute panel. Also, the American Farm Bureau finds that the new EU requirements on traceability and labeling are unfeasible, the 0.9 threshold arbitrary, and that the labeling could be prejudicial for GM products. It asked Washington to "aggressively prosecute its case" in front of WTO. (Ref.: IEM July)

In the Monsanto case, the ECJ ruled that the mere presence of residues of transgenic protein in novel foods does not prevent their being placed on the market under a simplified procedure provided there is no risk to human health.

The Court also ruled that the safeguard clause included in the Novel Foods Regulation reflects the precautionary principle. (Ref.: Case C-236/01)

On June 27, the Commission presented the conclusions of three research and development projects on the environmental impact of antibiotics which can be found in waste water. (Ref.: IP/03/391)

On June 2, the EU Health Ministers reached a political Agreement with qualified majority, on the three proposals of the pharmaceuticals package: a Regulation on the European Medicines Evaluation agency, a Directive on human medicines and a Directive on veterinary medicines. The Common Positions shall be formally adopted without debate in the coming months, and be transferred to the Parliament for Second Reading.

On June 25, the Commission adopted a Directive on a code relating to medicinal products for humans. It notably amends Directive 2001/83/EC, in a way to implement the recent international harmonization of terminology and format for applications. (Ref: Directive 2003/63/EC)

On July 24, the Court of Justice dismissed the Commission appeal against a first instance judgment (Case Artegodan T-74/00).

On March 9, 2000 the Commission had taken a Decision to withdraw marketing authorizations of anti-obesity drugs, containing certain anorectics. Artegodan and other pharmaceuticals companies had sought annulment of this decision. On November 26, 2002, the Court of First Instance annulled the Decision on the ground that the Commission lacked competence to withdraw marketing authorizations which were granted by national authorities, and not pursuant to the EU Directive. The Court of Justice confirmed the CFI judgment.
(Ref.: N°65/2003 / Case C-39/03, Artegodan / IEM-Sept)

On July 8, the EFTA Court rendered a judgment in a case of parallel import, in which it confirmed the right of a Danish parallel importer to introduce repackaged medicines. (Ref.: Case E-3/02)

On July 16, the Commission adopted a proposal for a Regulation harmonizing nutrition and health claims made on food and food supplements. The proposal aims to ensure that food claims will be based on scientifically proven nutrition benefits and will harmonize the conditions for their uses. As a result claims such as "low fat", "sugar free", "no added sugars", "high fibre" or "light" are prohibited unless the products actually respond to the definitions given in the Annex. (Ref.: COM(2003) 424 / IP/03/1022)

The European Food Safety Authority, which was established by Regulation 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, has had the 164 members of its scientific committees and panels appointed. EFSA may now begin its assessment activities for the Commission. EFSA is provisionally based in Brussels. The definitive location has yet to be determined by the EU Heads of State.

The Commission and Member States have agreed the rules of procedure of EFSA : there will be a register of own initiative and requested opinions. EFSA cannot change the wording of a request unless the institution asking the question agrees.

Not only the Commission, but also the Parliament and the Member States will be entitled to request EFSA opinions. The text also sets that EFSA can refuse to issue an opinion, for example if the question is posed by someone not entitled to make requests. (Ref: IEM July)

The German Federal Office of Consumer Protection and Food Safety is implementing a minimization concept which seeks to reduce the amount of acrylamide in the 10% of food containing the highest levels. In that framework, it presented some results showing it was possible to reduce the amount of acrylamide in food up to 25%.

On July 2, the European Parliament adopted its Second Reading position on the labeling of ingredients present in foodstuffs. The amendment to Directive 2000/13 repeals the 25% rule for the labeling of ingredients of compound ingredients. The EP notably required stricter provisions on the labeling to protect persons who suffer from allergy.

On July 3, the European Parliament adopted its First Reading position on the proposal for a Directive amending Directive 95/2/EC on food additives other than colours and sweeteners. The MEPs have among other called for the Commission to restrict the number of additives authorized and for a review of certain additives. (Ref.: COM(2002)662)

On June 20, the Commission took emergency measures to ban hot chilli products containing Sudan red 1, a chemical dye not permitted in food. (Ref.: Decision 2003/460)

Following the ECJ ruling authorizing Danish stringent measures on nitrates and nitrites, the Commission asked the Member States to provide data on the need of these substances and on the observed amounts. It will then require an opinion from EFSA on the minimum levels required in meat products to preserve the food guarantee microbiological safety. (Ref.: Case C-3/00)

On June 13, the Environment Ministers met in Luxembourg for the last Environment Council of the Greek Presidency. They achieved:

• Environmental Liability: Political Agreement
• Emission from non road machinery: debate
• Greenhouse gas monitoring: debate
• REACH consultation: debate
• Paraquat inclusion in Annex I to 91/414: debate
• Cross boarder movements of GMOs: adoption of Regulation
• Convention on long-range transboundary air pollution: decision on membership

(Ref.: Council 10273/03 (Press 165))

On June 13, the Environment Council adopted a Political Agreement for a Common Position on the proposed Directive on Environmental Liability with regard to the prevention and remedying of environmental damage. The German, Austrian and Irish delegations voted against this Agreement, but their votes did not prevent a qualified majority. On September 2, the Common Position was adopted.

Strict liability shall be applied among others to industries covered by the IPPC Directive (Directive 96/61/EC on Integrated Pollution Prevention and Control; including energy industries, production and processing of metals, mineral industry, chemical industry, waste management). The Member States may unveil the operator liability if the operator can demonstrate that his activity has been expressly authorized.

The Member States are still reserved on the Parliament proposal for mandatory insurance. They asked for this issue to be discussed after five years, and encourage the development of financial security instruments and markets.

On June 18, the Commission presented a Communication on a future Integrated Product Policy (IPP). It follows the Green Paper on IPP released in February 2001. It consists in a strategy for reducing the environmental impact caused by products during their whole life-cycle and for identifying products for which the greatest improvement could be reached. The life-cycle of a product is defined as "from the extraction of natural resources, through their design, manufacture, assembly, marketing, distribution, sale and use to their eventual disposal as waste."

This strategy does not fix stringent targets but would rather be organized by the market, with great involvement of the various stakeholders. It is deemed to cover all products, to be flexible, and defined product by product using a variety of tools.

Accordingly, the program proposed by the Commission to implement this strategy is as follows:

• until October 2003: Stakeholders are asked to present proposals for volunteer pilot projects;
• 2003-2004: launching of the identified pilot-projects;
• 2005: publication of a practical handbook on best practice with life cycle assessment (LCA); release of a discussion document on product design;
• 2007: action proposal for products identified as having the greatest potential for green improvement.

(Ref.: COM(2003)302 / IP/03/858 / IEM July)

On July 22, the Council adopted its Second Reading position on the Directive on greenhouse gas emissions trading.

The amendments clarified the method of allocation of emission allowances: they should in principle be free, but Member States can use auctioning up to 5% during the first phase and up to 10% from 2008. It also requires Member States to show that their allocations reflect the Kyoto reduction targets. Member States will be allowed to grant temporary exclusions to installations if they do not distort competition.

Despite the calls of other sectors to participate from the first phase in this scheme (the chemicals industry, the aluminium and the transport sector), the Commission will consider a wider coverage only after 2004. During the second phase (2008-2012), Member States will be able to extend the scope of this scheme to chemicals and aluminium and to other greenhouse gases.

This Directive shall be implemented by Member States by December 31, 2003. (Ref.: Council 11598/03 (Press 215) / IEM July)

The Commission adopted on August 1 a proposal for a Directive which lays the basis for the adoption of mandatory eco-design requirements for specific Energy-Using Products, selected on the basis of established criteria and which will be subject to future Commission implementing measures. Its scope must be assessed in the framework of other Community legislation, such as WEEE and RoHS, the eco-label award scheme and EMAS. (Ref. COM(2003)453final).

On July 2, the EP adopted its Second Reading position on the proposal for an amendment to the Packaging and Packaging Waste Directive (Directive 94/62/EC) setting higher recycling and recovery targets. The MEPs notably required clear timetables and derogations to be set in the Directive as well as the definition of packaging and packaging waste. The Conciliation Committee is likely to be constituted in September (third stage of the codecision procedure).

On June 30, the CEC adopted a proposal for a Regulation amending the 1993 waste shipment Regulation 259/93 mainly as an attempt to align EC law with a recent amendment to the Basel Convention on shipment of hazardous waste and a revised OECD decision on transborder shipment of waste. The Commission is also preparing an amendment to the EU amber and red lists of waste to take into account the revised OECD decision. (Ref. COM(2003)379 / IP/03/925)

On June 2, the Commission presented a proposal for a Directive on the management of waste from the extractive industries (mining and quarrying). This legislation among others, aims to prevent water pollution from long-term storage of waste and to regulate storage facilities to minimize consequences from accidents.

On the same issue, Directive SEVESO II (96/82/EC) on major accidents will be modified to include mining waste (conciliation procedure). Best Available Techniques have been adopted under the IPPC Directive in May. (Ref. COM(2003)319 / IP/03/784)

On June 25-26, 20 European countries met in Bremen (Germany) for a joint meeting of the Helsinki and OSPAR Commissions on protection of the Baltic and North-East Atlantic.

On June 11, the Commission presented its strategy called SCALE (Science, Children, Awareness, Legislation and Evaluation), which aims to understand the relationship between environment and health as well as to identify and reduce diseases linked to environmental factors. The Commission will present a detailed action plan in June 2004 after a consultation period. (Ref.: COM(2003)338 / IP/03/823)

On June 19, the Commission issued a Communication on the implementation of the IPPC Directive (96/61/EC) in the Member States and launched a public consultation (until September 15) on the further action or tools that shall be developed. The Commission will then issue a report in 2004. Member States are furthermore urged to more rigorously require existing sites to fully operate BAT by October 2007. (Ref.: COM(2003)354)

On August 1, the Commission launched an 8-week Internet stakeholder consultation on harmonizing the cadmium content in fertilizers. For this purpose the Commission has published draft Community measures as well as several studies and a CSTEE opinion on risk assessment.

Cadmium is still not regulated at EU level under Directive 76/116/EEC on Fertilizers. Although there is no EU restriction on cadmium in fertilizers, derogations have been granted to Austria, Finland and Sweden, which are allowed to maintain the concentration limits they had fixed before their accession. Furthermore, other Member States have taken informal measures on the issue, which led to a very fragmented market.

Stakeholders are asked to submit comments by September 26. The Commission will issue a proposal for a Regulation by the end of the year. (Ref.: IP/03/144 / IEM Sept)

On July 16, the Commission adopted a proposal for a Directive aimed at minimizing the harmful effects of heavy metals (arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons (PAHs)) in the air. Adopted in the framework of Directive 96/62/EC on ambient air quality assessment and management, it proposes limit values and air quality monitoring by Member States.

Arsenic, cadmium, mercury, certain Nickel and PAHs (group of more than 20 carcinogens of similar chemical character, which are mainly emitted by incomplete combustion) are carcinogens for which, according to the Commission proposal, no threshold for adverse effects on human health can be identified. (Ref.: COM(2003) 423 / IP/03/1020)

The Commission initiated/continued a series of infringement proceedings:

• Directive 2000/76 on waste incineration: written warning (first stage of the procedure) to Belgium, Germany, United Kingdom, Italy, Greece, Portugal, Finland and Sweden.
• Directive 2000/69 on limit values for ambient air quality: written warning to Netherlands, United Kingdom, Greece, Spain and Portugal.
• Directive 96/62 on IPPC: written warning to Italy and Ireland, reasoned opinion (second stage of the procedure) to the Netherlands, and referral to the ECJ for Austria.
• Directive 2001/18 on national emission limits: written warning France, Belgium, Netherlands, Germany, Ireland, Italy, Greece, Spain and Portugal. Directive 2001/80 on large combustion plants: written warning to Belgium, Netherlands, Austria, United Kingdom, Ireland Italy, Denmark, Greece, Spain, Portugal and France.
• Directive 89/369 on municipal incinerators: written warning to Spain.
• Directive 2037/2000 on ozone depleting substances: Ireland referred to the Court of Justice.
• On June 23, the Commission issued a report on the implementation of Directive 85/337/EC on impact assessment. Only Denmark is not subject to infringement proceedings.

The Commission pursued infringement procedures against Netherlands, France and Belgium for not complying with Directive 86/609/EEC on animal experiments.

The Commission referred Belgium, Spain, France and Luxembourg to the Court of Justice for failing to implement Directive 1999/44 on guarantees for consumer goods. (Ref.: IP/03/1009)

July 1 was the start of the Italian Council Presidency. Its priorities for the next six months are:

• International relations
• Mediterranean countries
• USA
• Launching the IGC on a new EU Treaty
• EU economic performance
• Fiscal issues
• Energy
• EU Patent
• Research & development
• Sustainable pensions
• Energy security & environment
• Immigration policy

In the environment field, the Italian Presidency supports a liberal approach; it is in favor of voluntary agreements and positive action. The Presidency shall also prepare the 9th Convention of the Parties to the Convention on climate change (1-12 December 2003).

Priority legislative dossiers:

• greenhouse gas emissions trading, adoption 22/07
• GMOs traceability & labeling, adoption 22/07
• packaging & packaging waste, conciliation
• SEVESO II, conciliation
• environmental liability, Common Position (adopted 2/9)
• bathing water, Common Position
• VOCs, Common Position
• fluorinated gases, debate
• Kyoto flexible mechanism, debate
• IPP, debate
• access to environmental information, debate

POPs, air quality, ground water and the amendment to the WEEE Directive are not priority dossiers.

On July 18, the "European Convention on the Future of Europe", composed of high-level political representatives from Member States and headed by former French President Mr. d'Estaing, submitted to the President of the European Council a "Draft Treaty establishing a Constitution for Europe". The current text would change the map of the European Union replacing all current Treaties, giving the EU full legal personality (allowing the EU to negotiate and sign international Treaties) and modifying the current decision-making process.

While the Commission is generally satisfied with the current draft, it is expected to present several amendments on 17 September, after which it will submit its amended text to the Intergovernmental Conference (IGC) starting on 4 October. The ICG is expected to adopt the draft constitution in December 2003, and the final text could become effective in 2004.