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ＥＵ新化学品規制

EU Whitepaper "Strategy for a future Chemicals Policy" (2001/2/27)

　　　新化学品規制案 　　　　2003/5ＥＵ発表　　　

　　　日本政府コメント

2003/10/29最終案発表

2003/5/7 EU

Commission publishes draft new Chemicals Legislation for consultation

Enterprise Commissioner Erkki Liikanen and Environment Commissioner Margot Wallstrom today presented new proposals to overhaul and modernise the EU's regulatory system for chemicals. Following discussion of their approach, the European Commission gave the go-ahead for an 8 weeks' Internet consultation on the draft chemicals legislation. The aims of the proposed new Regulation, which will replace 40 different pieces of current legislation, are to increase the protection of human health and the environment from exposure to chemicals while at the same time to maintain and enhance the competitiveness and innovative capability of the EU chemicals industry. In delivering both these aims, the proposals aims at fully conforming to the balanced approach required by sustainable development. Chemical substances are used in the manufacture of almost all products we use every day at home or at work. The industry that produces them plays a vital role in sustaining the competitiveness and innovative potential of many final product manufacturers downstream. The system for registering, evaluating and authorising chemical products should therefore boost enterprise competitiveness and product innovation, to the long-run benefit of chemicals manufacturers and importers, users, consumers and the environment. The Internet consultation will enable interested parties to comment on the detail of the future legal requirements before the proposal is finalised by the Commission.

Enterprise Commissioner Erkki Liikanen said: "Europe is a world leader in chemicals production and in the supply of the materials which assure the innovation potential of European industry, including many high tech sectors. The new draft chemicals regulation which we are now putting out for consultation should provide important opportunities for European industry to lead the world in the quality and safety of chemicals production and use which, in Europe, is already at a high level. In the system that we are in the process of designing we are making a determined effort to avoid unnecessary bureaucracy, to help enterprises meet the new requirements at minimum cost, to encourage research and innovation, and to ensure that European industry remains competitive. This major piece of legislation is a great challenge in terms of reconciling the economic, social and environmental requirements inherent in the EU's sustainable development strategy. I believe that what we have presented today is a good basis for getting the balance right, but we are of course open to further input and comments from all stakeholders."

Environment Commissioner Margot Wallstrom said: "Everyday, we are exposed to chemicals in our environment, at work or in our homes. However, for many of them, we do not know enough about their risks or longer-term effects. Our reform proposal therefore requires industry to provide public information on the chemicals they produce or import and the risks associated with their use. This will allow the users to choose safer alternatives. It will greatly enhance the protection of people's health and the environment because we will insist on strict authorisation procedures for the substances which cause most concern. Obliging the industry to provide information on what it produces will also help to enhance the image of the chemicals sector. Industry will finally have an interest in investing in innovation of new safe chemicals - the current trend of using old chemicals to avoid the cumbersome current evaluation procedure has stopped investment into safer chemicals."

The REACH System (Registration, Evaluation, Authorisation of Chemicals)

The draft legislation, which will replace over 40 existing directives and regulations, will implement the proposals set out in the Commission's February 2001 White Paper on the Strategy for a future Chemicals policy (see IP/01/201). At its core is REACH: a single, integrated system for the Registration, Evaluation, and Authorisation of CHemicals. REACH will place a duty on companies which produce, import and use chemicals to assess the risks arising from their use requiring new test data to be generated in justified cases - and to take the necessary measures to manage any risks they identify. This will reverse the burden of proof from public authorities to industry for putting safe chemicals on the market. Testing results have to be shared to reduce any likely animal testing. Registration of information on the properties, uses and safe use of chemical substances will be an integral part of the new system.

Scope of REACH

The exact registration requirements will vary depending on the volume in which a substance is produced, and on the likelihood of exposure to humans or the environment. A phased-in system lasting up to 11 years is foreseen. Higher tonnage substances would require the most data, and would have to be registered first; lower tonnage substances would require less data and be registered later. The latter provisions will particularly reduce the regulatory burden on small and medium sized enterprises.

Tighter controls will be introduced for the chemicals of highest concern. Thus, certain types of substances such as carcinogens, mutagens and reproductive toxicants (CMRs), persistent, bioaccumulative and toxic substances (PBTs) and very persistent and very bioaccumulative substances (vPvBs) will be subjected to an authorisation regime and would be registered early. In certain cases also other substances, for example with endocrine disruption effects, could be included on a case by case basis within the authorisation system where it is shown that they give rise to the same level of concern.

Each use of such substances will have to be authorised for a specific use. Decisions would be based on a risk assessment and consideration of other socio-economic factors.

Others, such as polymers (chemicals used as raw materials for plastics and detergents and a wide variety of other products), and substances used as intermediates (chemicals used to make other chemical substances or other products) will be subject to substantially lighter registration requirements. In many cases, where there is little risk of exposure, polymers and intermediates will be exempted from registration.

It is expected that around 80% of all substances will only have to be registered, the rest will have to undergo evaluations for safety and subsequent authorisation

The Member States will be responsible for the evaluation of substances by examining certain registration dossiers, as well as checking the application of REACH within their own territories. They will also be able to suggest restrictions on the use of substances based on a structured risk assessment - where they consider that EU legislative action is necessary, although the final decision on such restrictions would be taken by the Commission.

The Commission would grant authorisations after taking into account the views of the Agency on the risk and on the socio-economic aspects. Authorisation decisions will take into account the guarantees provided by the applicant firms and available information on alternative substances and processes that may reduce the risk posed. To simplify the system and to reduce costs, an authorisation will be valid for enterprises further down the supply chain as long as they abide by the conditions of the authorisation for the intended use and inform the Agency.

A new Agency

A new Chemicals Agency is proposed to manage REACH which will have the task of ensuring the efficient operation of the new system. This will include providing advice to the Commission, and guidance to Member States and to enterprises, including SMEs. Non-confidential data generated by REACH will be made available to downstream users of chemicals and to the general public in a publicly accessible database managed by the Agency.

Research and Innovation

Research and innovation vital for the competitiveness of many small businesses in this sector will be encouraged by allowing research and development to take place without registration for 5 years, extendable to 10 years, which is a considerable extension of existing provisions.

In order to keep the need for animal testing to a minimum and to keep costs down, a system of data-sharing among companies is proposed. In addition, important elements of flexibility are proposed within the testing requirements, allowing industry to use alternative sources of information to fill data gaps, or to argue that certain tests are unnecessary because of a lack of exposure.

Objective of Internet Consultation

The purpose of the Internet consultation is to test the workability of the proposals with stakeholders. There are about 1200 pages of legislative text, largely made up of technical annexes that are not new requirements, as well as a range of brand new procedures. The Commission would like feedback on the drafts before finalising its proposal as soon as possible.

The text of the proposals may be found at:
http://europa.eu.int/comm/enterprise/chemicals/index.htm
http://europa.eu.int/comm/environment/chemicals/whitepaper.htm or
http://europa.eu.int/comm/press_room/presspacks/reach/pp_reach_en.htm
See also: MEMO/03/99.

http://europa.eu.int/comm/enterprise/chemicals/chempol/reach/explanatory_note.pdf

The New Chemicals Legislation : REACH

Following the adoption of the White Paper, the Commission's services have prepared a consultation document concerning the Registration, Evaluation and Authorisation of Chemicals.

EXPLANATORY NOTE

1. Purpose of this note
　 This note explains the essential features of a new system to implement the policy set out in the Commission´s White Paper of February 2001 on the ‘Strategy for a future Chemicals Policy'. The new system, developed jointly by the Enterprise Directorate-General and the Environment Directorate-General, is called REACH ‐ Registration, Evaluation and Authorisation of CHemicals.
　 　
2. Duty of Care
　 A central feature of the new system is a duty on all companies that manufacture, import and use chemicals - regardless of the quantity - to use substances in such a way that human health and the environment are not adversely affected. This is achieved by assessing the risks arising from the manufacture, import or use of those chemicals and taking the necessary measures to manage any risks identified.
　 　
3. Registration
　 Registration requires manufacturers and importers of substances gather information on the substances they manufacture or import, and use the information for responsible and well-informed management of the potential risks of the substance.
This is documented in their Chemical Safety Report (Annex I).
All firms manufacturing substances in, or importing substances into, the EU in quantities of 1 tonne or more per manufacturer or importer per year will be required to submit relevant information to the Agency before new substances are first manufactured in or imported into the EU. The information required increases at the tonnage thresholds of 10, 100 and 1000 tonnes respectively (Annexes V to VIII).
　 Substantial efforts have been made to minimise costs and animal testing by allowing:
　
- the use of existing sources of information,
- the use of information not based on testing of vertebrate animals where possible
(especially below the 10 tonne threshold),
- the reading across of data from analogous substances,
- the sharing of test results,
- the grouping of similar substances, and
- the dispensing with some requirements altogether where the information is not needed because of the properties or use of the chemical, or that more extensive information is already available. For example, testing can be waived in some cases on the grounds of lack of exposure during its intended use.
　 　
　 To ensure greater cost/resource efficiency, companies manufacturing or importing the same substance can form consortia and share information needed for registration. To facilitate this manufacturers and importers of substances that are already on the market will have to ‘pre-register' their substance(s). Those manufacturers and importers having pre-registered the same substance will then be participants of a ‘substance information exchange forum' (SIEF), where they will exchange available information on tests involving vertebrate animals. This will save time, money and reduce animal testing.
If information required for substances manufactured or imported in quantities of 100 tonnes and more per year (set out in Annexes VII and VIII) is not available, testing proposals to meet these requirements will have to be submitted as part of the registration (for it to be complete). These proposals will be examined by the authorities at the evaluation stage to ensure only the right tests will be performed and to avoid double testing.
As regards research and development, exemptions from REACH requirements will be available for substances subject to product and process orientated research and development, for up to 10 years, i.e. initially 5 years, which can be renewed for a further 5 years.
　 Special reduced registration requirements have been developed for polymers and intermediates:
　
- Polymers with certain dangerous properties will be subject to a reduced registration package, other polymers will be exempted from registration altogether. Monomers will follow the general rules. Many polymers subject to registration will only need to be registered after 12 years.
- Non-isolated intermediates, kept in closed systems, are excluded from the REACH system altogether.
　 　
　 For intermediates used on site or transported to up to two other sites under strictly controlled conditions, as the exposure potential is limited, less information needs to be submitted than for other substances.
The information gathered on intrinsic properties of substances will help manufacturers and importers to improve the assessment of their risks and the development of measures to adequately control those risks. Chemical safety assessment will need to cover manufacturers´ and importers´ own uses of a substance as well as uses by downstream-users they supply with the substance.
Registrants will have to assess at least 90 % of these so-called ‘intended uses' of their substances. The assessments will be documented in the Chemical safety report.
To ‘phase-in' the new system, deadlines will be established for registration of substances that are already being manufactured. This will start with substances in quantities of 1000 tonnes or more, and substances that are carcinogenic, mutagenic or toxic to reproduction (CMR substances) below that tonnage, 3 years after the Regulation comes into force, and end with substances in quantities of 1 tonne or more after 11 years.
As a consequence of introducing a single system for all substances, the current notification requirements for new substances, contained in Directive 67/548/EEC, will be repealed. Substances previously notified under this system will be considered to be registered.
　 　
4. Substances in articles
　 Substances in articles in quantities of 1 tonne or more will also have to be registered if sufficient amounts of the substance are released to pose a risk, to human health and/or the environment, and the substance has not already been registered for that use. For reasons of practicality, this requirement will be phased in shortly after the registration deadlines for substances (at the relevant tonnage level).
　 　
5. Downstream users and Information through the supply chain
　 Under the REACH system, manufacturers and importers of substances will provide downstream users with the information they need to be able to fulfil their duty of care, i.e. in particular information on recommended risk management measures for the ‘intended' uses. A downstream user will only have to report his use of a substance to the Agency, if he uses it in a way that was not intended by his supplier or if he disagrees with the recommended risk management measures. This report might under very exceptional circumstances include testing proposals if a downstream user considers them necessary. This reporting requirement will be phased in after the respective registration deadlines for the suppliers. Downstream users of substances in quantities of under 250 kg/year have no reporting obligation.
　 　
6. Evaluation
　 There are two types of evaluation under REACH:
　
1. Standard evaluation: Testing Proposals submitted by industry for substance-tailored testing involving animals, for substances above the 100 tonne threshold, will be subject to evaluation by a Member State Competent Authority (CA) to avoid unnecessary animal testing and to ensure high quality. Testing must then be performed and information submitted following the CA decision on the testing proposal.
Generally, the CA of the Member State responsible for the registration will also evaluate the testing proposals. It is proposed, however, that ‘phase-in' substances should be allocated to Member States' CAs on the basis of their populations.
　 　
2. Priority evaluation: CAs may also perform a more in-depth evaluation of any substance. Such an evaluation is voluntary. For that purpose, the CA of a Member State may check the quality of information submitted in the registration and may ask for additional information if the quality of information submitted was not sufficient or if there is a reason for concern. A substance shall only be evaluated by one Member State at a time and any evaluation must be based on previous work.
To ensure consistency, decisions by individual CAs on further testing will be agreed through a Community-wide procedure. The Agency also has a key role in identifying any inconsistent application of the process. Disagreement between CAs can ultimately result in a Commission decision being required.
　 　
7. Authorisation
　 All uses of substances with intrinsic properties of very high concern will have to be authorised, once such a substance is identified in Annex XIII.
　 　
　 Such substances of very high concern are:
- category 1 and 2 CMRs;
- substances which are persistent, bioaccumulative and toxic (PBT);
- substances which are very persistent and very bioaccumulative (vPvB), and
- other substances, such as endocrine disruptors, that present an equivalent level of concern.
　 　
　 Substances to be authorised will be identified in Annex XIII along with a deadline for applications, and the date by which applications must be processed by the authorities. First priority will be given to substances where regulatory action will have the greatest impact on the protection of human health and the environment.
Prior to inclusion in Annex XIII, some PBTs and vPvBs, and certain other substances giving rise to similar levels of concern will have to be identified on a case-by-case basis. A Member State initiating the procedure to subject such substances to the authorisation system, has to demonstrate that PBT or vPvB properties or equivalent properties of very high concern are present. This is subject to an agreement procedure, which may result in a Commission Decision in the event of disagreement between the Competent Authorities.
To obtain an authorisation, a manufacturer, importer, or downstream user will have to demonstrate that the risk from the use of a substance can be adequately controlled or that the socio-economic benefits outweigh the risk. Authorisation decisions for uses for which the risks cannot adequately be controlled, should take account of available information on alternative substances and processes that may replace the use. To focus efforts on aspects of highest concern, authorisations will only consider risks from the properties that led a substance to be subjected to authorisation (if a carcinogen is also an irritant, the irritancy will not be considered).
Community wide authorisations will be granted by the Commission after considering a recommendation of the Agency in all cases where the applicant places, or intends to place, the substance on the market.
To simplify and lighten the system, an authorisation will be valid for enterprises further down the supply chain as long as they abide by the conditions of the authorisation for the intended use and inform the Agency.
Grouping of applications for authorisation is also possible, subject to justification by the applicant. Groups can be: manufacturers, importers and downstream users; substances; uses; or any combination of these groups. This is to enable costs to be minimised and to enable the system to process applications rapidly.
　 　
8. Restrictions
　 The restrictions process acts as a general ‘safety net' for the whole REACH system. Any substance may be subject to restrictions (e.g. banning, or allowing particular uses under specified conditions), regardless of whether they are subject to registration or not. The restrictions process enables risk reduction measures to be introduced across the Community where they are shown to be necessary. Member States may suggest restrictions to be proposed by the Commission by sending a structured dossier to the Agency. The Agency will deliver an opinion to the Commission on the risks identified and the socio-economic impacts, taking into account alternative substances and processes. Restrictions will be adopted by a Commission Decision in a comitology procedure.
The Commission can also make use of the restrictions process to, for example, add new category 1 and 2 CMRs to the existing ban for consumer use or to implement relevant aspects of international agreements on persistent organic pollutants (POPs).
　 　
9. Agency
　 A newly created, independent Agency will be at the centre of the REACH system. It will play a key role in supporting the Commission, Member States and other actors with technical expertise and by establishing and running the IT infrastructure.
Through its expert Committees, it will advise the Commission:
- on priorities to set up the authorisation procedure,
- on applications for authorisations for the uses of substances of very high concern,
- on risk reduction measures for dangerous substances.
　 　
　 Furthermore, the Agency will help ensure a common approach between Member States, in particular in the evaluation stage and in enforcement issues. For the latter purpose, it will establish a forum of Member States to co-ordinate a network of enforcement authorities to promote a common approach to implementation of the measures.
The Agency will be established with an Executive Director appointed by the Management Board on the proposal of the Commission and responsible to the Board consisting of 15 representatives, including 6 nominated by the Commission. All Member States will be invited to make nominations for appointment to the Agency's Committees; the Management Board will appoint members on the basis of established competence. The aim will be to have nationals from all Member States, which make suitable nominations, present on the committees.
Most of the costs of the Agency will be met by fees fixed by the Agency and levied on enterprises for registration and authorisation, the remaining costs will be met by funding from the Commission.

　

IP/03/1477

Brussels, 29 October 2003

Chemicals: Commission presents proposal to modernise EU legislation

The European Commission today presented a proposal for a new EU regulatory framework for chemicals. Under the proposed new system called REACH (Registration, Evaluation and Authorisation of CHemicals), enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register it in a central database. The aims of the proposed new Regulation are to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH would furthermore give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information would be passed down the chain of production. The proposal has been drafted in close consultation with all interested parties, including via an Internet consultation. This has allowed the Commission to propose a streamlined and cost-effective system. The proposal will now be forwarded to the European Parliament and the EU's Council of Ministers for adoption under the so-called co-decision procedure.

Enterprise Commissioner Erkki Liikanen said: "I believe that we now have arrived at a proposal that strikes the right balance between maintaining growth and employment in Europe on the one hand and improving health and the environment in Europe on the other. Both the chemicals industry itself and Europe's manufacturing sectors that depend on chemicals are key contributors to economic activity in all Member States. Safeguarding their competitiveness is a priority. The mechanisms built into today's proposal are cost-effective and they will enhance the innovative capability of our industry. The proposal will also provide for a stable framework within the internal market and a new independent chemicals agency will help guaranteeing that."

Environment Commissioner Margot Wallström said: "REACH is a groundbreaking proposal. Once adopted, It will allow us to take advantage of the benefits of chemicals without exposing ourselves and the environment to risks. Thus it will create a win-win situation for industry, workers and citizens, and our ecosystem. It will give Europe's citizens the high level of protection that they have the right to expect. The EU will have one of the most progressive chemicals management systems in the world."

The REACH system

The proposed Regulation would replace over 40 existing Directives and Regulations. At the core of the proposed system is REACH a single, integrated system for Registration, Evaluation and Authorisation of CHemicals. REACH would require companies that produce and import chemicals to assess the risks arising from their use and to take the necessary measures to manage any risk they identify. This would reverse the burden of proof from public authorities to industry for ensuring the safety of chemicals on the market.

Registration: This is the main element of REACH. Chemicals that were manufactured or imported in quantities of more than one tonne per year and per manufacturer/importer would be registered in a central database. Some groups of substances would not have to be registered (such as certain intermediates, polymers and some chemicals managed under other EU legislation). The registration would include information on properties, uses and safe ways of handling the chemicals. The information required would be proportional to production volumes and the risks that a substance poses. The safety information will be passed down the supply chain, so that those that use chemicals in their own production processes - to produce other products - could do so in a safe and responsible way, without jeopardising the health of workers and consumers and risking damage to the environment.

A new European Chemicals Agency would manage the database, receive the registration dossiers, and be responsible for providing non-confidential information to the public. It is expected that around 80% of all registered substances would require no further action.

Evaluation: There would be two types of evaluation; of dossiers and of substances. Firstly, a dossier evaluation would have to be carried out on all animal testing proposals The main purpose of this compulsory evaluation would be to minimise animal testing. REACH has been designed with the goal of restricting animal testing and costs to industry to the necessary minimum. It would require the sharing of data obtained in tests and encourages the use of alternative sources of information. A dossier evaluation could also be performed to check that the registration was in compliance with the registration requirements.

Secondly, the competent authorities could evaluate any substance where they had justified reasons to suspect that there was a risk to human health or the environment. This would represent a quality and compliance check. The programme of substance evaluations would be based on rolling plans prepared by Member State Competent Authorities. The programme would take account of criteria for setting priorities drawn up by the Agency.

For both types of evaluation, the outcome could be a request for further information. The Agency would take the final decision on requests for further information if all Member States agreed. In case of disagreement, the European Commission would make a decision.

Authorisation: Substances of very high concern would require authorisations for particular uses from the Commission. Substances of very high concern include CMRs, PBTs, vPvBs and substances identified as having serious and irreversible effects to humans and the environment equivalent to the other three categories. If the risks emanating from the use of such a substance could be adequately controlled, authorisation would be granted.

If they could not be adequately controlled, the Commission would look at the level of risk, whether the use of the substance was socially and economically important and if there were substitutes. Based on these factors the Commission would decide whether the substance would be authorised. The Commission would also be able to introduce restrictions at EU level on substances that needed to be managed at an EU-wide level to ensure that the risks they posed were acceptable.

The proposed new system would set high standards for protection of health and the environment while safeguarding the competitiveness of enterprises and improving the potential for product innovation. This balance would be to the long-term benefit of chemicals manufacturers, importers, users, small and medium sized enterprises, consumers and for health and the environment.

To safeguard the competitiveness and enhance the innovative capability of the chemicals industry in the EU, REACH has been designed to simplify the existing EU regulatory framework for chemicals. The proposed new system would thus focus on:

Innovation

Incentives for research have been built into REACH, which would enhance innovation. The proposed new system would encourage research and innovation by raising the threshold for registration from currently 10 kg to 1 tonne, thus allowing research and development on substances to be carried out below this volume without registration. In addition, the trial period for research and development would be lengthened to up to ten years. This period would be extended by a further 5 years for medicinal products. For downstream users the new system would mean a simplification of the regulation which would make it easier for them to find new innovative uses of substances.

The overall costs of the proposal would be substantially reduced compared to earlier estimates. The draft proposal posted on the Internet earlier this year has been thoroughly revised to cut costs and minimise bureaucracy. In the new Impact Assessment, the direct costs of REACH to the chemicals industry are estimated at a total of some ? 2.3 billion over an 11 year period representing a saving of 82% costs from the Internet draft.

The costs to downstream users of chemicals are estimated at ? 2.8 to 3.6 billion over a period of 11 and 15 years respectively - if the market reacts as expected with 12 per cent of substances being withdrawn because continued production would not be profitable. Costs could rise to ? 4.0 to 5.2 billion if industry faced higher supply chain adaptation costs. These estimates include the direct costs passed on from the chemicals sector to downstream users.

The total costs for the chemicals industry and the downstream users are thus estimated to ? 2.3 to 5.2 billion.

The anticipated benefits to environment and human health are expected to be significant. An illustrative scenario put the health benefits in the order of magnitude of ? 50 billion over a 30-year period.

REACH is an example of participatory policymaking. The new system has been drafted in close consultation with all interested parties, and various studies have been conducted to examine the costs and benefits of different options.

In May of this year, the Commission presented a draft of the proposed Regulation on the Internet to gather further comments on the workability of REACH. Some 6,000 replies were sent in. The main contributors were industry associations and individual companies, as well as environmental and animal rights NGOs. A number of Member States also provided comments, alongside several countries outside the EU. In addition, many individuals, including workers, expressed their opinions.

The comments have resulted in important changes to make the proposed new system less costly, less bureaucratic and more workable, while reinforcing the guarantees for health and environmental protection.

Background - problems with the current legislation

The current legislative system for chemicals has been largely unable to identify the risks posed by many chemicals and is slow to act where risks have been established.

The current legislation distinguishes between so-called "existing" and "new" chemicals using 1981 as a cut-off date. "Existing" substances are those that had been introduced before 1981; "new" chemicals are those that have been introduced since.

New chemicals have to be notified and tested in production volumes as low as 10kg per year, while there are no such provisions for existing chemicals. This has encouraged the continued use of "existing", untested substances and inhibited research and development and innovation. The number of new chemicals put on the market since 1981 has reached only around 3,000.

The number of "existing" chemicals in 1981 was 100,106. It has been up to the public authorities to determine whether any of them need to be examined, and if so, to do it. The procedures have been lengthy and cumbersome. For example, since 1993 140 high-volume chemicals have been singled out for risk assessment. Only a very limited number has completed the process so far.

REACH would put an end to the artificial distinction between "new" and "existing" chemicals.

The text of the proposal can be found at:

http://europa.eu.int/comm/enterprise/chemicals/chempol/whitepaper/reach.htm

http://europa.eu.int/comm/environment/chemicals/whitepaper.htm

See also: MEMO/03/213

JULY 7, 2009

UPDATE:EU Crt Says REACH Rules On Monomers, Polymers Valid

Europe's highest court has ruled that a provision in the European Union's chemical regulation REACH, requiring monomers that have been reacted to form polymers to be registered, is valid.

The court found that the regulation's coverage of monomers, chemical building blocks that create polymers when they are reacted and linked together, should be considered to include the reacted monomers that have bound together to make a polymer.

The court was hearing a judicial reference from the U.K.'s High Court, which is considering challenges from several companies over the regulation's provisions on monomers and polymers.

The plaintiffs include French organic chemical firm S.P.C.M. SA, German chemical conglomerate C.H. Erbsloeh KG, U.K. chemical technical services specialist Lake Chemicals and Minerals Limited, and former U.S. chemical firm Hercules Inc., which was taken over in 2008 by Ashland, Inc. (ASH), another U.S. chemical firm.

The REACH Regulation requires the registration of all chemicals made or imported into the E.U. Polymers are excluded from the regulation but monomers aren't. In addition, monomers making up over 2% of the weight of a polymer must be registered if they weren't registered at an earlier stage in the manufacturing process and if the total amount of the monomer exceeds one metric tons a year.

The chemical companies argued reacted monomers shouldn't have to be registered, as they are chemical components of polymers, which aren't covered by the regulation.

REACH規則では、ポリマーは登録と評価は除外されていますが、ポリマーを構成する2wt％以上のモノマーが、年間1t以上になると、登録対象になる

　

European Court looks at REACH safety regulations - 05-02-2009

The European Court of Justice has taken its first look at some of REACH's provisions in a case listed for hearing on 27 January 2009, which is important both for the substantive issues involved and for its insights into the strategy of some chemical firms.

The case is basically about getting particular provisions of the REACH Regulation annulled. As firms cannot directly attack the Regulation in the ECJ, they have taken a roundabout route. Four firms - SPCM (based in France), CH Erbslöh KG (Germany), Lake Chemicals and Minerals Limited (United Kingdom) and Hercules (based in the USA) - issued proceedings against the UK government's environment department (Defra) to force a referral by the UK's High Court to the ECJ for preliminary rulings on three questions.

The High Court handed down its judgment on 11 October 2007. It declined to refer two of the three questions raised by the firms, and agreed to refer one. This question relates to article 6 (3) of REACH requiring monomers to be registered. The applicant firms contended that to apply this requirement to all monomers would be irrational, discriminatory or disproportionate. It is a tortuous procedure by which the four firms are basically trying to get article 6 (3) annulled.

What is the central issue to this case? The European Commission originally proposed that polymers should be registered, but with certain exemptions. Polymers are chemicals composed of repeating structural units of low molar mass*, known as monomers. Plastics, for instance, are polymers. One of the most infamous monomers in health and safety at work terms is vinyl chloride monomer, which has been responsible for thousands of deaths in the plastics industry. Other highly toxic monomers used in the chemical industry include styrene, acrylamide and butadiene.

As a result of chemical industry lobbying, registration of polymers was dropped from the final version of REACH through a general exemption in laid down article 2 (9). But monomers still have to be registered, and the duty applies to all polymer manufacturers and importers if two conditions are met: the polymer consists of a minimum percentage of monomers, and the total quantity of monomers ending up in the final polymer either unbound or chemically bound to the polymer makes up 1 tonne or more a year.

REACH's wording is crystal clear on this point. All monomers that meet the article 6 (3) conditions must be registered. What the chemical industry is doing under the guise of getting the legislation clarified is trying to get a fresh exemption that would apply to what they call "reacted" monomers, i.e., ones that have formed covalent bonds with a sequence of other molecules to form a polymer. The fact that these monomers no longer have the form of individual substances with toxicological characteristics unlike polymers is irrelevant to health and safety at work, because their toxicity as monomers can expose production workers to risks.

This case typifies the chemical industry's strategy of whittling away the rules that protect the health of workers, the public and the environment. The British government seems to be in two minds about this case. DEFRA believes that the question as to a purported direct contradiction between article 2 (9) and article 6 (3) of REACH stands a reasonable chance of success in being referred to the ECJ, but that "the government does not necessarily agree that the claim is valid".