EuChemS Newsletters

The regulatory work of ECHA

Did you know that ECHA´s RAC met to draft an opinion on dodecyl methacrylate under the CLP Regulation?[1]
Aside from the chemistry part, assuming that you are a chemist, there is a good chance that the question above is unintelligible to you. Nonetheless, it is deeply related to the work of chemists, innovators, and to everyone´s lives. Just as an example, the chemicals present on the screen of the device that you are using to read this article were certainly approved through ECHA. ECHA´s workflow is an extremely complex subject, especially when you look into how concrete dossiers are processed but, hopefully, by the end of this article you will understand my initial question while having an overview of how the safety of chemicals is assessed within the European Union.

ECHA´s creation and mandate

The European Chemicals Agency (ECHA) is one of many agencies in the European Union, which are separate legal entities created to perform specific tasks under EU law. ECHA, which is based in Helsinki, Finland, was set up in 2007 by the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation as the entity that should “provide the Member States and the institutions of the Community with the best possible scientific and technical advice on questions relating to chemicals”[2] falling under the scope of the REACH Regulation. Over the years its mandate has grown and ECHA is also responsible for the management of the Regulation on “Classification, Labelling and Packaging of substances and mixtures” (CLP Regulation) since 2009; the Biocidal Products Regulation (BPR) since 2012; and also for some of the tasks of the Prior Informed Consent (PIC) Regulation since 2014 (even though this regulation is from 2012)[3]. The common ground for these regulations is the fact that they legislate chemicals with the purpose of assuring healthy environments while boosting competitiveness. As formulated by ECHA itself in its mission statement, this agency aims to be the “driving force among regulatory authorities in implementing the EU’s groundbreaking chemicals legislation (that is REACH, CLP, BPR, and PIC regulations) for the benefit of human health and the environment as well as for innovation and competitiveness. ECHA helps companies to comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern.”[4] It is important to mention that these four legislative acts are regulations, which means that they are applicable in all EU Member States without the need for transposition into national law.

REACH, CLP, BPR, and PIC

The objective of REACH[5] is to “ensure a high level protection of human health and the environment, including the promotion of alternative methods such as animal friendly methods] for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.”[6] REACH applies to almost all chemical substances from those used in industrial processes, to those used in our daily lives such as paints or cleaning products. Companies are responsible for the identification and management of risks linked to the substances they manufacture and market in the EU. They must demonstrate to ECHA how a certain substance can be used safely and they must communicate this information to users. Under this regulation, certain substances can be restricted, and the most hazardous ones should be substituted over time. REACH affects manufacturers, importers, and downstream users (companies using chemicals produced by other companies).

The REACH assessment of a substance normally starts with companies registering a substance. ECHA receives and evaluates individual registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA’s scientific committees assess if the risks of substances can be managed. Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorisation.

The CLP Regulation aims “to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles.”[7] [8] It does this by obliging all industrial sectors to classify, label and package their hazardous chemicals appropriately before placing them on the market. Once a substance or mixture is classified, the identified hazards must be communicated to other actors in the supply chain, including consumers. The regulation sets detailed criteria for the labelling elements: pictograms, signal words and standard statements for hazard, prevention, response, storage and disposal, for every hazard class and category. CLP also manages alternative chemical names in mixtures, which may be used to safeguard intellectual property, and sets the information that companies must provide so that EU poison centres can promptly respond to health emergency calls[9].

The BPR Regulation[10] aims “to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment”. [11] Biocidal products are used for the “control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured materials” [12], these include, among others, insecticides[13], insect repellents, disinfectants, and preservatives for materials. Companies should apply for approval of active substances at the EU level with the subsequent authorization of biocidal products at Member State level. Substances under certain conditions are allowed to be granted authorisation across the EU.

The PIC Regulation[14] manages the import and export of certain hazardous chemicals and places obligations on companies who wish to export these chemicals to non-EU countries. Its objective is to “promote shared responsibility and cooperative efforts in the international movement of hazardous chemicals in order to protect human health and the environment from potential harm.”[15] This is achieved by providing so-called ‘third countries’ with information on how to store, transport, use and dispose of hazardous chemicals safely in accordance with the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade.[16]

ECHA is not the only agency dealing with chemicals in the EU

One should take into consideration that some groups of chemicals do not fall under the remit of these four regulations and that ECHA is not the only agency dealing with chemicals in the EU. For instance, pharmaceuticals fall under the European Medicines Agency (EMA), while biocidal products for plants (such as herbicides/pesticides) or food additives are the remit of the European Food Safety Authority (EFSA). To assure coherence, ECHA and other agencies have set up cooperation on evidence-based opinion making in order to ensure consistent decision making.[17] There are also some tasks that are shared between ECHA and the European Commission. For instance, under the BPR, DG SANTE (Directorate-General for Health and Food Safety) is responsible for a number of scientific issues, such as criteria for endocrine disruptors[18].

Note that REACH, CLP, BPR, and PIC regulations amount to thousands of pages and that the summary above is an overview largely based on the information presented at ECHA´s website.

 

The role of science in ECHA

In order to provide scientific input to the regulatory processes of ECHA, the agency has four scientific committees: 1) The Committee for Risk Assessment (RAC) prepares the opinions of ECHA related to the risks of substances to human health and the environment in the following REACH and CLP processes; 2) The Committee for Socio-economic Analysis (SEAC) prepares the opinions of ECHA related to the socio-economic impact of possible legislative actions on chemicals in the following REACH processes; 3) The Member State Committee (MSC) participates in several REACH processes. The MSC is responsible for resolving divergences of opinions among Member States and on proposals for the identification of Substances of Very High Concern. Finally, 4) The Biocidal Products Committee (composed of representatives from EU Member States), provides opinions to support decision making on biocidal active substances and products. It is important to state that the final decisions are taken by the European Commission, based on the opinions provided by the scientific committees.

EuCheMS has also been active in the work of ECHA

Members for each committee are appointed by Member States but meetings can also be attended by accredited stakeholder organisations such as EuCheMS, which is a regular presence at RAC meetings and has had an active role by providing presentations on different topics. EuCheMS has also been active in the work of ECHA by providing experts to support the drafting of scientific and technical guidance[19] that aims to facilitate the implementation of the regulations. Other types of collaborations have also taken place, such as the participation of Tim Bowmer, Chair of the Committee for Risk Assessment, at a EuCheMS workshop on glyphosate.[20]

Even though chemistry is a transversal presence in many European agencies, its role in ECHA is particularly relevant. With more than 17,000 unique substances on its database, this agency deals directly with chemicals for which safety must be scientifically determined and whose impacts will be felt in our health, environment and economy, thus showcasing a rather strong case of how chemistry is fundamental to our lives.

[1] https://echa.europa.eu/documents/10162/5cdb8a11-a38e-f9d2-a952-57f339fad318
[2] http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02006R1907-20161011&from=EN
[3] ECHA Programming Document 2017 – 2019 https://echa.europa.eu/documents/10162/2200151/final_mb_32_2016_echa_programming_document_2017-19_en.pdf/f4ae8819-a825-451b-b36d-853a27fd498c
[4] https://echa.europa.eu/about-us/who-we-are/mission
[5] https://echa.europa.eu/regulations/reach/understanding-reach
[6] http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02006R1907-20161011&from=EN
[7]  “‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition; ‘mixture’ means a mixture or solution composed of two or more substances; ‘article’ means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;”
[8] http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R1272-20170101&from=EN
[9] https://poisoncentres.echa.europa.eu/
[10] https://echa.europa.eu/regulations/biocidal-products-regulation/understanding-bpr
[11] http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:167:0001:0123:en:PDF
[12] http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:167:0001:0123:en:PDF
[13] Only the ones not covered by the Plant Protection Products Directive http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32009R1107
[14] https://echa.europa.eu/regulations/prior-informed-consent/understanding-pic
[15] http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02012R0649-20160201&from=EN
[16] http://www.pic.int/TheConvention/Overview/TextoftheConvention/tabid/1048/language/en-US/Default.aspx
[17] Page 13 https://echa.europa.eu/documents/10162/2200151/final_mb_32_2016_echa_programming_document_2017-19_en.pdf/f4ae8819-a825-451b-b36d-853a27fd498c
[18] https://echa.europa.eu/about-us/partners-and-networks/eu-bodies
[19] https://echa.europa.eu/guidance-documents/guidance-on-reach
[20] http://www.euchems.eu/policy-and-communication/policy-workshops/glyphosate-harmless-tool-sneaky-poison/

Bruno Vilela
EuCheMS Public Affairs Officer