Enlarging the Environment

Newsletter from the European Commission on environmental approximation

Published by DG XI, Issue No 12, August 1998

ISSN 1028-1517

EU CONTROL OF CHEMICALS

In 1977, a accident in Seveso, northern Italy, contaminated a large area with a highly toxic dioxin. As a result of this accident, and increasing public concern about the use of chemical products within the Union, more stringent measures have been taken by the Commission to reduce the risks arising from the manufacture and disposal of chemical substances. Directives are aimed at regulating such things as the classification, packaging and labelling of dangerous substances as well as the composition of detergents.

Since 1981, there has been a European Inventory of Existing Chemical Substances which lists all chemical products on the market, enabling them to be subject to a general procedure for notification, evaluation and control. A directive adopted in June 1982 makes sure that manufacturers in all Member States inform authorities about substances, plants and the possible location of accidents.

Chemical legislation is one of the oldest in the EU. In 1967, the EU adopted directive 67/548/EEC on the classification, packaging and labelling of dangerous substances. This was the first of a number of directives to protect human health and the environment from chemicals. Over the years, the EU has established and developed a comprehensive system of laws and programmes to make sure that chemical products are manufactured, used and disposed of in safety and without harming the environment.

In the early years, the chemicals control legislation was basically laying down a legal foundation of basic standards, many of which are still relevant. With the advent of the Fifth Environmental Action Programme, the EU's legislation in this area took a new direction. It is now based on a partnership between regulators, industry and the general public. The key legislation which makes up the EU's chemicals control system covers:

• new chemicals coming onto the market
• existing chemicals (some of which are dangerous)
• standards and voluntary programmes which foster good environmental management and environmentally friendy products.

The chemicals control legislation takes a preventive approach. Industry is asked to identify, assess and inform governments and the public of potential risks and safety measures. Later legislation is developed based on this information.

Commercial confidentiality is protected by the chemicals notification procedure. However, any data relating to health and environmental protection and the chemical make-up of any dangerous substance has to be made public.

This is guaranteed through directive 90/313/EEC on the freedom of access to information about the environment. This directive gives the public greater access to information held by public authorities and requires all Member States to regularly disseminate basic information about the state of the environment.

In 1979, the EU adopted what is known as the sixth amendment (to the Directive 67/548/EEC). This sets up a system for testing and notifying the new chemicals coming onto the market.

A seventh amendment was made in 1992 through directive 92/32/EEC which mainly looked at ways to assess potential risks of notified chemicals. Pre-market notification gives new commercial chemicals a "doorway" through which they can be sold within the EU. Anyone manufacturing chemicals outside the EU can use someone inside the EU as their sole representative for the purpose of notification.

The Commission and Member States have wide powers to monitor the quantities and uses of chemicals and preparations in the EU and to identify and control potential problems. Industry must provide information about uses and potential exposure. Member states are able to demand further tests and information from manufacturers.

Interview

Coping with Chemicals

Enlarging the Environment has talked with Mr. G. Corcelle, head of DG XI's chemicals unit (E.2.).

While Mr Corcelle sees chemicals legislation as of fundamental importance within the EU's environmental framework, he believes the main challenge facing the candidate countries in this area is capacity building. " This is a very complex issue - technically and strategically. These countries will need institutions, quality people and good organisation in order to take on the EU acquis in this area," explains Mr Corcelle.

While the candidate countries are preparing to build the needed institutions, Mr Corcelle points out that even in the existing Member States the necessary infrastructure does not always exist in sufficient numbers. "Not even in Member States; for example in Greece, Portugal, France - and France is the second largest chemical industry after Germany within the EU - there are some problems of allocating resources to this issue. I see the answer as building a capability, a good organisation with quality people."

“Another problem”, points out Mr Corcelle, is making sure the new Member State choose the right institution or ministry to implement and enforce EU chemicals legislation. "these countries need to make the right choice because chemicals affect not just the environment but other areas. They could opt for using the health, environment or industry ministries or specify an agency or scientific body to do the work. They need to make the choice in light of the existing chemical industry in their own country. It is different in each country and it depends on what they have had in the past and what they expect to have in the future. Even if you don't have your own chemical industry, for safety reasons you have to consider this. You have for instance, to think about the transport of dangerous chemicals. From the beginning of our discussions with the candidates, we are saying that chemicals legislation is far-reaching. It touches other Commission Directorate-Generals, like competition, industry, health and employment. It has wider protection issues. It is not simply an area of concern for DG XI”.

“Behind EU chemicals legislation lies the protection of consumers, the health of workers. It's not just the protection of the environment. It covers more - health, consumers and workers. The environmental criteria contained in chemicals legislation is only a small part of the legislation," explains Mr Corcelle.

Mr Corcelle remains convinced that the key to successful implementation and enforcement of the EU's chemicals rules and regulations is setting up a workable system.

"The problem is not that there will be more legislation. We have basically completed our traditional task and the legislation today covers all relevant areas related to the manufacturing, marketing, export, import of chemicals. What we need to do is to restructure existing legislation. It needs to be simplified and made more effective. It needs to be targeted. The legislation will in future also need to cover new concerns. There will clearly be a need for shifting the attention from purely focusing on questions related to chemical processes and safety, but towards a comprehensive approach to the product itself, including safety isusses related to recycling and the final disposal as waste," says Mr Corcelle.

As for helping the candidates to put into place the chemicals acquis, Mr Corcelle says work has already begun. "We have participated in some seminars in the recent past to explain the complex legislation. But another help for the candidates is the fact that the chemicals programme is linked, to some extent, to other international programmes such as the OECD programme on chemicals. Some of the candidate countries are full members of OECD and are required not just to adopt EU laws, but OECD rules as well"

Mr Corcelle also points out that the chemicals industry's own organisation, CEFIC, is playing a leading role. "It is a big help. Many of the candidate countries' industries are already included in this industrial association. Together with CEFIC, we at the Commission have proposed a kind of training programme, awareness-raising exercise. It is a tripartite effort: CEFIC, the Commission and the candidate countries."

One potential stumbling block for the candidate countries, believes Mr Corcelle, is the fact that most chemicals legislation from the legal point of view are directives. “Regulations are legally quite easy to handle for Member States, as the obligations of the regulation automatically is binding national law. But the major part of chemicals legislation consists of directives which must be transposed into national law.

This transposition-process often leaves a certain room for interpretation – and mis-interpretation - and because of this, candidate countries need to be more careful in how they “translate” the requirements of the directives into national legislation. It is also more difficult," explains Mr Corcelle.

"Yes, there will be some problems since these directives are very complex from a technical point of view and also very detailed. Directives classification and labelling aspects and provisions cover over 5,000 pages. That means a really big effort to understand, apply and control all the provisions. It's very complex and training will be necessary. Probably the best approach will be through twinning with the existing competent authorities in existing Member States to help the candidates. We, at the Commission, have no practice in this area. It's the member states who apply, control and implement EU laws. The national authorities are where you should go to if you want practical answers to questions," says Mr Corcelle.

He sees Germany - with the largest chemicals industry in the world – as well as Britain, as two good examples for the candidate countries. "Britain is well organised and is a good example from that perspective for the candidate countries," he concludes.

The chemicals unit at DG XI consists of around 30 persons, some of which work in the biotechnology area. "We have a good and close working relationship with our Joint Research Centre in Ispra, Italy. All our work depends on the preparation of scientific and technical details done by the European Chemicals Bureau in Ispra."

"For purely historical and administrative reasons, biotechnology is together with the chemicals unit. The only member state where this linkage exists is in the UK where the Department of the Environment is responsible for both chemicals and biotechnology. All the other member states have split the administration between different ministries or departments. But it makes good sense to link the two. The approach to risk assessment and health is broadly similar. Also, biotechnology is largely using the model of chemical legislation which is older and more developed,"concludes Mr Corcelle.

Defining dangerous chemicals

The 1979 directive drew a line between new and existing chemicals. Existing chemicals were defined as those which were not subject to notification because they had been on the market between September the 18th 1971 and September the 18th 1981. These chemicals were listed in the European Inventory of Existing Commercial Chemical Substances (EINECS). ELINCS is the actual list of over 100,000 notified substances. Dangerous substances, in EU terms, are those which have characteristics bringing them within one or more of the 15 categories of hazard, ranging from explosive to dangerous for the environment. A chemical substance is considered "new" and, therefore, must be notified to the Commission, if it is not listed in EINECS. These chemicals are exempt from notification, but if they are marketed within the EU they must be classified and labelled by the manufacturer or importer as dangerous.

The European Environment Agency and the European information and observation network were set up in 1990. The agency, based in Copenhagen and operational since 1994, provides reliable data for the Union, member states and third countries. It gives objective information which is used to draw up and implement effective environmental protection policies. The agency supplies technical, scientific and economic information needed for preparing and implementing measures and laws related to environmental protection. It has also developed forecasting techniques to enable appropriate and preventive measures to be taken ensuring that European environmental data are incorporated into international environmental programmes. The agency harmonises and co-ordinates the collection and evaluation of European environmental data and works with public and private environmental research and monitoring institutions within the EU and in non-member counties.

National authorities are required by EU law to make information on the environment available to any natural or legal person upon request without the person concerned having to prove an interest.

Working with Mr. Guy CORCELLE in DG XI (Unit E 2) are:
Hervé MARTIN	Deputy Head of Unit.
Marc DEBOIS	Co-ordinator, –Management of biocides and pesticides –transportation of dangerous chemicals
Béatrice HUMBERT	Competition, Infractions.
Carla PICINNI-LEOPARDI	Co-ordinator (-International activities Co-ordination of substances)
Susanna LOUHIMIES	Co-ordinator of Directive 86/609 “Laboratory animals”and related decisions.
Hanny NOVER	Classification of dangerous substances (Directive 67/548)
Klaus TYRKKO	Pesticides (Directive 91/414 and supplementary measures)
Walter CORTELLINI	Management of biocides.

New implementation network in candidate countries

Environment Commissioner, Ms. Ritt Bjerregaard, has launched a network for the implementation and enforcement of environmental law in the 10 candidate countries in central and eastern Europe and Cyprus. This informal network, called AC-IMPEL, comprises officials from the accession countries working with national authorities dealing with the implementation and enforcement of environmental legislation. AC-IMPEL will work in close co-operation with the already-existing EU IMPEL network in order to support the candidate countries in addressing issues related to the implementation and enforcement of EU environmental legislation during the pre-accessionphase.

Ms Bjerregaard says, "The idea behind this network is a simple and practical one: it is based on the recognition that environmental law, which isn't implemented, is not worth the paper it is printed on. We have had enough of fine legal 'green-speak' both in the EU member states and in your countries. Now is the time for genuine action. Action which addresses the real problems and difficulties for the environment and does something about them."

It is composed of representatives (called national co-ordinators) of all accession countries, namely Bulgaria, the Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, the Slovak Republic and Slovenia. The network is chaired by the Commission. (Mr Timo Mäkelä, Head of A4 Unit, DG XI). The Secretariat is also managed by the Commission (Mr Balodimos, DG XI.Unit A.4).

The main activities of AC-IMPEL will include:

a) Two plenary meetings a year in the associated countries by rotation;

b) Exchange programmes for inspectors (including participation of inspectors from the candidate countries to the corresponding IMPEL projects and programmes for the inspectors of the candidate countries with the participation of IMPEL experts);

c) training programmes for inspectors;

d) an analysis of the countries’ systems of implementation and enforcement;

e) addressing problems in relation to the approximation of particular EU environmental legal acts;

f) possible publications;

g) special ad hoc projects; and

h) participation in IMPEL projects

Communication on Accession Strategies for Environment

The Commission has adopted a ‘Communication on Accession Strategies for the Environment’ to complement the accession partnerships. It also provides help to the candidates in updating and detailing the National Programmes for the Adoption of the Acquis ( NPAA). Effective, prioritised management of the approximation process is crucial because of the limited resources. It requires careful strategic planning and cost-effective programmes. An initial Commission estimate of the total investment costs of meeting the environmental acquis is ECU 100bn-120bn for all 10 Candidate countries. The bulk of investment will be needed for air pollution abatement, water and waste water management and management and disposal of municipal and hazardous waste.

Before accession the candidates should together with the EU, draw up and start implementing national long-term strategies for gradual and effective alignment with the environmental acquis, particularly for tackling water and air pollution. This strategy for adoption and implementation of the environmental acquis should be combined with a reinforced EU pre-accession assistance strategy where investment for adoption of the environmental acquis is one of the priorities.

The Communication examines some of the practical questions, which the Commission believes the candidates should take into account when developing national strategies. The Communication focuses on issues related to the candidates only as the situation for Cyprus is different with respect to the economic and historical background and to the EU instruments for financial co-operation. The main sector specific challenges for the candidates, according to the Commission, relate to air and water quality, waste management, industrial pollution control and nuclear safety. A survey of EU assistance instruments and programmes which can help the candidates meet EU environmental standards are outlined in the document. These include funding and assistance programmes to mobilise further resources for environmental improvements, to assist and advise the countries in the environmental approximation process and to support implementation and enforcement of environmental legislation. Financial assistance from the EU will cover only a minor part of all needed investments. However, the EU's financial assistance can have a catalytic effect in mobilising other resources. A comprehensive financial strategy and operational modalities for the use of EU financing instruments will be established within the framework of the accession partnerships and the national programmes for the adoption of the acquis.

The full text of the document Accession Strategies for the Environment: Meeting the Challenge of Enlargement with the Candidate Countries in Central and Eastern Europe, is available on this web site.

Approximation Agenda

Round up of meetings relevant to environmental approximation between now and December 1998

September 14	Commissioner Ms Ritt Bjerregaard meets the Ministers of Environment from the Candidate Countries.	Brussels.
September 18	EPRG (Environmental Policy Review Group)	Brussels.
October 7-9	Commissioner Ms Ritt Bjerregaard visits Slovenia.	Slovenia.
November	Environmental Sub-committee for the Czech Republic	Brussels
4th quarter 1998.	Environmental Sub-committee for Lithuania.	Location to be decided
4th quarter 1998.	Environmental Sub-committee for Poland.	Location to be decided
4th quarter 1998.	Environmental Sub-committee for Slovakia.	Location to be decided