How does REACH work?
All manufacturers and importers of chemicals must identify and manage risks linked to the substances they manufacture and market. For substances manufactured or imported in quantities of 1 tonne or more per year per company, manufacturers and importers need to demonstrate that they have appropriately done so by means of a registration dossier, which must be submitted to the European Chemicals Agency (ECHA).
The Agency may then check that the registration dossier complies with the Regulation and must evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals, but also that adequate information is provided.
Where appropriate, authorities may also select substances for a broader substance evaluation to further investigate substances of concern.
REACH also foresees an authorisation system aiming to ensure that the risks from substances of very high concern are properly controlled, and those substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. Where risks cannot be adequately controlled, the use of those substances may only be authorised where there is an overall benefit for society of using the substance and there are no suitable alternatives.
In addition, EU authorities may impose restrictions on the manufacture, use or placing on the market of substances causing an unacceptable risk to human health or the environment.
The Member States authorities are responsible for enforcing REACH through inspections as well as penalties in case of non-compliance.
Role of the European Commission
Prior to the entry into force, the European Commission was responsible for the preparing the legislation and supporting the European Parliament and the Council during the decision making process. At the same time, preparatory work for REACH implementation began several years before the legislation was adopted. This included the preparation for the setting up of the European Chemicals Agency in Helsinki but also the preparation of IT tools, guidance documents and the creation of a network of helpdesks that will support industry and authorities to fulfill their tasks under REACH. More information on the work of the Commission prior to the entry into force of REACH.
After entry into force of REACH on 1 June 2007, many of those tasks, including the provision of information on REACH to companies and the general public have been transferred to the European Chemicals Agency (ECHA). You can find on its website a wide range of information, including legislative texts, summaries of the legislation, press materials, brochures, guidance documents, Frequently Asked Questions and links to national helpdesks.
Nevertheless, the European Commission keeps an important role in updating and completing the REACH legislation and in taking decisions in a number of REACH processes, in particular authorisation and restrictions. Moreover, it actively participates in updating REACH guidance and supports the European Chemicals Agency in its tasks.
The Commission has been reviewing a number of REACH Annexes. More information about these reviews.
In parallel, the Commission has prepared implementing legislation that is necessary to put the provisions of REACH into effect, such as:
- a Regulation on fees, which sets fees to be paid by industry for e.g. registration and applications for authorisation
- two Regulations on the arrangements for the Board of Appeal of the European Chemicals Agency
- a Regulation on test methods
In these tasks, the Commission is supported by a regulatory Committee composed of representatives from all Member States. In parallel, REACH implementation issues are discussed in the group of Competent Authorities for REACH and CLP (CARACAL).
The Commission is also involved in giving advice on key issues related to the interpretation of REACH. This concerns giving advice on draft guidance documents and on helpdesk questions to ECHA and the REACH helpdesk network. In this context, the Commission and ECHA have been working on how nanomaterials are to be treated under REACH. Moreover, the Commission has elaborated a paper to clarify REACH obligations of waste and recovered substances [134 KB] . Several drafts of this paper have been consulted with Member States and stakeholders. The main views expressed by the Member States and the stakeholders at the REACH Competent Authorities meeting on 25 and 26 September 2008 [13 KB] are also available. The paper has been handed over to ECHA for finalisation and updating the relevant guidance documents.
The Commission is also preparing for its future tasks under REACH:
It will have a key role in the authorisation process, as it will identify substances that are subject to authorisation, and decide whether to grant the authorisations. It will also issue decisions regarding restrictions.
The Commission also has representatives in the Management Board of the Agency and may participate to the meetings of the Committees of the Agency.