Registration, Evaluation and Authorisation of Chemicals: REACh

The REACh Regulation [1] concerning the Registration, Evaluation and Authorisation of CHemicals (REACh) entered into force on 1 June 2007. It aims at improving the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. It is a true overhaul of the European regulatory system as it replaces around forty previously existing regulations and directives.

REACh seeks to better understand the effects of chemicals on human health and the environment for effective management of the risks associated with the use of these products. It also sets out the gradual substitution of the most hazardous chemicals in the European Union, in particular substances of very high concern such as those that are carcinogenic, mutagenic and toxic for reproduction.

To accomplish this, the Regulation contains several provisions as well as obligations directed at producers and importers of chemicals, which have the effect of reversing the burden of proof from public authorities to industry. In other words, it is now the industrial company which must demonstrate that a substance can be used without risk to human health or the environment.

Among the important provisions contained in the REACh Regulation was the creation of a European Chemicals Agency (ECHA) based in Helsinki, whose role is to ensure the system’s implementation, management and administrative, scientific and technical coordination.

Based mainly on data from registration applications, the provisions of the Regulation (evaluation, authorisation, restriction) help ensure that substances placed on the market do not pose a risk to human health or the environment.

Registration

To continue to market chemicals produced in quantities equal to or greater than one tonne per year, producers or importers of the chemical must register that substance. This means that they must provide certain information about their substances’ manufacture, identified uses and toxicological and ecotoxicological properties. Otherwise, they will no longer be able to place their chemical on the market. The guiding principle is: ‘no data, no market.’ The information required varies depending on the tonnage of the chemical placed on the market.

Beyond an amount equal to or greater than 10 tonnes on the market, the producer or importer of the substance must also provide a Chemical Safety Report (CSR), which is a risk assessment along with suggested risk management measures that are necessary for ensuring the safety of people and the environment.

Evaluating Applications and Chemicals

As a key player at this step in the process, the European Chemicals Agency must perform quality control and compliance checks on registration applications to verify that the correct information is available and presented appropriately: this is called the application evaluation (Conformity Check). The applicant may then be asked to provide additional information if necessary.

As part of this assessment, and to limit unnecessary testing on animals, ECHA must evaluate all testing proposals in an application for registration of a chemical manufactured or imported in quantities of 100 tonnes or more (Testing Proposal).

REACh also provides for a thorough assessment of chemicals for which there is a doubt/concern, in order to remove or confirm the doubt, while also allowing for additional information to be requested from the manufacturer if necessary.

The European Chemicals Agency, in collaboration with Member States, has developed a triennial work programme, updatable annually, of chemicals for priority evaluation using a risk-based approach (information on hazards, exposures, quantities etc.). This is the CoRAP (Community Rolling Action Plan) which was first published on 28 February 2012.

Evaluations are then carried out on a voluntary basis by the Member States and can lead, depending on the findings, to requests for further information/studies. If the evaluating Member State considers that the risk management measures proposed in the Chemical Safety Report cannot ensure the protection of people and the environment, it may propose risk management measures such as authorisation or restriction.

Authorisation

The authorisation procedure seeks to ensure control of the risks arising from chemicals of greatest concern in order to gradually replace them by other appropriate and safer substances or technologies. This measure applies, without any tonnage limit, to substances of very high concern, i.e., those that are carcinogenic, mutagenic and toxic to reproduction from Category 1 and 2; substances that are persistent, bioaccumulative and toxic (PBTs); very persistent and very bioaccumulative (vPvB) and, by extension, any substance that raises a level of concern equivalent to a CMR or PBT/vPvB, particularly endocrine disruptors (EDCs).

This procedure is divided into two stages. The first step is to identify the substances eligible for the authorisation procedure, mentioned above, and include them on the list (Annex XIV of the Regulation) of substances subject to authorisation. The initiative for this identification can come from a Member State (MS) or from the Commission, which will ask the European Chemicals Agency to prepare the dossier. Once substances have been listed in Annex XIV, their use is subject to prior authorisation. The application for authorisation, which must include a number of items including an analysis of the alternative substances or technologies that exist, or, in certain cases, a substitution plan, must be submitted to the European Chemicals Agency. Authorisation may be granted for a limited period and may be renewed if it can be shown that the risks associated with the use of the substance are legitimately controlled. Otherwise, and in the absence of technically and economically viable alternatives, an authorisation may be granted if it can be shown that the socio-economic benefits outweigh the risk identified.

Restriction

Finally, the restriction procedure is the ‘safety net’ of the system established by the REACh Regulation, because it allows Member States or the European Commission to intervene and propose risk management measures for any chemical, independent of the tonnage, whenever they believe that placing this substance on the market or its use poses a risk that is not adequately controlled.

The Member State or the ECHA, at the Commission’s request, expresses its intentions (up to proposing an outright ban on the production and use of the substance) in a restriction dossier sent to the ECHA. The proposal must identify the uses and the risks to be restricted and must take into account information about the possibilities of replacing the chemical, the socio-economic impact of the proposed measures, and consultation with all the stakeholders.

Deciding on Management Measures

Granting authorisation and deciding on restrictions are done through a committee procedure involving the various Member States and chaired by the European Commission. These decisions are made taking into account the opinions of ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC). In these committees, the participation of experts nominated by the Member States and appointed by the European Agency is essential.

ANSES’s Role

The Memorandum of Understanding signed on 3 November 2011 between ANSES and its supervisory ministries organises the roles of each of the signatories in implementing the REACh and CLP Regulations.

The French Ministries of Sustainable Development, Labour and Health are responsible for France's implementation of the REACh and CLP Regulations. The Directorate General for Risk Prevention (DGPR) of the French Ministry of Ecology, Sustainable Development and Energy is the designated national competent authority for the REACh Regulation. It carries out this role in close collaboration with the Directorate General of Labour (DGT) of the French Ministry of Labour, Employment, Vocational Training and Social Dialogue as well as the Directorate General of Health (DGS) from the French Ministry of Social Affairs and Health. The DGT is the designated national competent authority for the CLP Regulation.

ANSES’s mission is to conduct scientific and technical evaluations within its field of expertise. It provides the necessary expertise to the ministries for implementing the REACh and CLP Regulations.

ANSES suggests chemicals to the ministries that it deems relevant to study in order to propose, where appropriate, that risk assessment procedures and management measures be undertaken within the framework of either REACh (authorisation/restriction) or CLP (harmonising classification). Depending on ANSES’s assessment and recommendations, the ministries decide:

• to propose that a substance be evaluated within the CoRAP framework;
• to initiate the creation of an identification file for a substance of very high concern in order to include it in Annex XIV of REACh (substances subject to authorisation);
• to initiate the creation of a restriction dossier to include the substance in Annex XVII;
• the drafting of the REACh Regulation, including the part on analysing the socio-economic impacts of a proposed restriction;
• to initiate the creation of a classification dossier in order to include the substance in Annex VI of the CLP Regulation.

In addition, ANSES experts are involved in two ECHA committees: the Committee for Risk Assessment and the Committee for Socio-Economic Analysis (liens ECHA). These committees formulate the European Chemicals Agency’s opinion on applications for authorisation from manufacturers, or on proposals for restriction and classification/labelling developed by other Member States.

Finally, ANSES informs the French public about the risks of substances identified within the REACh framework, in close collaboration with its supervisory ministries and the European Chemicals Agency.

[1]  Regulation (EC) no 1907/2006