Evaluation and control of the risks of existing substances

The European Union has laid down common rules to ensure the systematic evaluation and better management of the risks linked to existing substances as well as, where appropriate, new protective measures. The purpose of these rules is, as part of the internal market, to protect humans and all parts of the environment from the possible effects of exposure to dangerous chemical products.

ACT

Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances [Official Journal L 84 of 05.04.1993] [See amending acts].

SUMMARY

The Regulation sets up a programme designed to identify and control the risks posed by some of the existing chemical substances listed in EINECS (European Inventory of Existing Commercial Chemical Substances).

Structure

The measures set out in the Regulation seek to lay the foundations for risk evaluation, both now and in the future, and at the same time to ensure the sharing and coordination of responsibilities among the Member States, the Commission and the manufacturers. The Member States, for their part, are required to appoint one or more competent authorities to ensure the implementation of this Regulation.

Committee procedure

For the purposes of implementing the Regulation and introducing adaptations to technical progress, the Commission is assisted by a Regulatory Committee, hereinafter referred to as "the Committee", made up of representatives of the Member States and chaired by a representative of the Commission.

Information required

Since it would not be possible to try to collect the information and evaluate the risks for all "existing" substances, the Regulation makes a distinction in approach in terms of the quantities of the substance produced or imported.

The Regulation provides for a systematic approach for "existing" substances produced or imported in quantities in excess of 10 tonnes/year; for the substances of smaller production or import volumes, the collection of information and the risk evaluation are carried out on a case-by-case basis.

The data to be provided vary according to the quantity manufactured or imported and the dangers that the substance presents.

Manufacturers or importers are obliged to provide, for all substances, the detailed data specified in the Annex to the Regulation, viz.

• the name and number of the substance listed in EINECS (European Inventory of Existing Commercial Substances);
• the quantity of the substance produced or imported;
• substance classification pursuant to Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances;
• reasonably foreseeable uses of the substance.

In the case of substances manufactured or imported in large quantities (in excess of 1 000 tonnes/year), additional data (likewise specified in detail in the Annex) must also be provided, e.g. data on the physico-chemical properties, ecotoxicity and carcinogenicity of the substance. The Commission, in cooperation with the Member States, will determine those cases where such additional information is also required for substances manufactured or imported in small quantities.

All this information must be submitted to the Commission within 12 months of the entry into force of the Regulation in the case of substances manufactured or imported in large quantities and within 24 months in the case of substances produced or imported in smaller quantities and listed in EINACS.

A number of substances, listed in the Annex, are exempted from these obligations. However, requests for information on these same substances may be made through the Regulatory Committee.

Reporting of information

When submitting the requisite information, manufacturers and importers must use only the HEDSET (Harmonised Electronic Data Set) software, available free of charge from the Commission. All the data are subsequently recorded in IUCLID (International Unified Chemicals Information Database). Member States may also stipulate that manufacturers and importers established in their territory should simultaneously provide their competent authorities with information identical to that submitted to the Commission. The Commission will forward the data to the other Member States.

Responsibility for updating the information provided rests with the manufacturers and importers.

Listing of priority substances

Due to the large number of substances covered by the Regulation, a priority setting approach has been adopted.

The lists of priority substances are drawn up and published each year by the Commission, assisted by the Committee. The substances included are those that require priority attention because of their possible effects on man and the environment; special attention is accorded to substances with potentially chronic effects, such as carcinogens.

A number of criteria may be taken into account when deciding whether to include a substance, such as the effects on man and the environment, the absence of data on the effects of the substance and the work already carried out in other international fora.

A substance already evaluated under other Community legislation may only be placed on the list if the evaluation in question fails to take account of risks to man and the environment.

With a view to drawing up the lists and evaluating the risks associated with the priority substances for which additional information is required, manufacturers and importers are under an obligation to:

• provide the authority designated as rapporteur for the substance in question with all available and relevant information as well as the corresponding research reports within six months of the date of publication of the list;
• carry out, within 12 months, all necessary additional tests in accordance with the provisions of Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances, if such information has not already been provided.

Role of the Member States in evaluating the risks associated with the substances on the priority lists Each of the substances on the priority lists is allocated to a "rapporteur" Member State empowered to designate on behalf of the Community. Risks are evaluated on the basis of Regulation (EC) No 1488/94 pursuant, in principle, to the criteria previously set for the new substances listed in Commission Directive 93/67/EEC. This should ensure that all the substances are evaluated in the same way.

For each substance allocated to it, the Member State in question will designate a competent authority as rapporteur. This authority is responsible for evaluating the risks to man and the environment and, where appropriate, for overseeing the proposed strategy on limiting these risks, including control measures and/or monitoring programmes.

In order to carry out these tasks, the authority will use all relevant information and may, if necessary, ask for additional information and tests. In such cases, a formal request must be submitted to the Commission which, after consulting the Committee, will pass on the request to the manufacturer or importer.

The rapporteur will draw up an evaluation project and, where appropriate, a risk reduction strategy for the attention of the Member States.

Role of the Commission in evaluating the risks associated with the substances on the priority lists

On the basis of the risk evaluation project and, where appropriate, of the risk reduction strategy put forward by the Member States, the Commission will present to the Regulatory Committee a draft recommendation for adoption at Community level by the Commission, assisted by the Committee. These documents will subsequently be published by the Commission.

The position as far as the "existing" substances is concerned is that they will remain on the market until such time as specific action is taken in their regard. The Regulation does not provide directly for risk reduction measures, although it may give rise to such measures being taken.

If the risk reduction strategy contained in the Recommendation proposes limiting the marketing and use of a substance, the Commission may decide to propose measures under Directive 76/769/EEC on restrictions on the marketing and use of certain dangerous substances and preparations. Furthermore, other Community instruments may be used with a view to reducing the threats posed by the substance under examination.

Confidentiality

The provisions are intended to ensure, where appropriate, data confidentiality. However, certain information such as physico-chemical data and summaries of the results of toxicological and ecotoxicological tests cannot be accorded protection on the grounds of manufacturing and business secrecy. Decisions on confidentiality will be taken by the competent authority in the relevant Member State and must be respected by the other Member States.

New regulatory framework for chemical products

The European Union is seeking to modernise European legislation on chemical products and set up the REACH system, a single integrated system for registering, evaluating and authorising chemical substances. This system would replace the existing one organised under the current Regulation.

RELATED ACTS

Drawing-up of the priority lists:

Commission Regulation (EC) No 1179/94 of 25 May 1994 [Official Journal L 131 of 26.05.1994] (As well as drawing up the first list of priority substances, the Regulation determines which Member States are to be responsible for each substance).

Commission Regulation (EC) No 2268/95 of 27 September 1995 [Official Journal L 231 of 28.09.1995]

(Second list of priority substances and Member States responsible).

Commission Regulation (EC) No 143/97 of 27 January 1997 [Official Journal L 25 of 28.01.1997] (Third list of priority substances and Member States responsible).

Commission Regulation (EC) No 2364/2000 of 25 October 2000 [Official Journal L 273 of 26.10.2000] (Fourth list of priority substances and Member States responsible).

Risk evaluation:

Commission Regulation (EC) No 642/2005 of 27 April 2005 imposing testing and information requirements on the importers or manufacturers of certain priority substances in accordance with Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances [Official Journal L 107 of 28.04.2005]. Under this Regulation, manufacturers and importers are required to carry out further testing and submit additional information on 12 existing priority substances. The further tests and information required, as well as the time limits for communicating the results, are listed in the Annex.

Commission Regulation (EC) No 2592/2001 of 28 December 2001, imposing further information and testing requirements on the manufacturers or importers of certain priority substances in accordance with Council Regulation (EEC)No 793/93 on the evaluation and control of the risk of existing substances [Official Journal L 345 of 29.12.2001] With regards to the present Regulation, manufacturers and importers are required to carry out further testing and to submit additional information on 12 existing priority substances. The further tests and information required, as well as the time limit for communicating the results are specified in the Annex.

Commission Recommendation of 29 April 2004 on the results of the risk evaluation and the risk reduction strategies for the substances: Acetonitrile; Acrylamide; Acrylonitrile; Acrylic acid; Butadiene; Hydrogen fluoride; Hydrogen peroxide; Methacrylic acid; Methyl methacrylate; Toluene; Trichlorobenzene [Official Journal L 144 of 30.04.2004].

Commission Recommendation of 16 September 2002 on the results of the risk evaluation and risk reduction strategy for the substance diphenyl ether, octabromo derivative [Official Journal L 249 of 17.09.2002].

Commission Recommendation of 4 July 2002 on the results of the risk evaluation for the substances: ethyl acetoacetate, 4-Chloro-o-cresol, Dimethyldioctadecylammonium chloride [Official Journal L 181 of 11.07.2002].

Commission Recommendation of 4 July 2002 on the results of the risk evaluation and the risk reduction strategies for the substances: o-anisidine, 1,4-dioxane [Official Journal L 181 of 11.07.2002].

Commission Recommendation of 5 March 2001 on the results of the risk evaluation and the risk reduction strategies for the substances: diphenylether/pentabromo derivative and cumene. [Official Journal L 69 of 10.03.2001] The Recommendation provides for the adoption of risk evaluation for these two substances, featuring in the first and second priority list, and for the adoption of a risk reduction strategy for the substance diphenylether/pentabromo derivative.

Commission Recommendation of 12 October 1999 on the results of the risk evaluation and on the risk reduction strategies for the substances: 2-(2-butoxyethoxy)ethanol; 2-(2-methoxyethoxy)ethanol; Alkanes, C10-13, chloro; Benzene, C10-13-alkyl derivs [Official Journal L 292 of 13.11.1999]

The Recommendation provides for the adoption of the risk evaluation and reduction strategy for the substances featuring in the priority lists.

Commission Regulation (EC) No 2161/1999 of 12 October 1999 imposing further testing requirements on the importers or manufacturers of a certain priority substance as foreseen under Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances. [Official Journal L 265 of 13.10.1999] The Regulation imposes further testing requirements, detailed in the Annex, for amines, tallow alkyl. The "rapporteur" Member State must be notified of the results within six months of the date of entry into force.

Commission Regulation (EC) No 142/97 of 27 January 1997 concerning the delivery of information about certain existing substances [Official Journal L 25 of 28.01.1997] The Regulation imposes an obligation to provide information on the exposure of man and the environment to certain substances.

Other

Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances [Official Journal L 161 of 26.06.1994].

Last updated: 27.06.2005