Agencies [EU]

Table of Contents

European Chemicals Agency (ECHA)

— how the EU regulates chemicals

Regulation (EC) No 1907/2006 — concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency

Purpose

The REACH (registration, evaluation, authorisation and restriction of chemicals) regulation provides a comprehensive legislative framework for chemicals manufacture and use in Europe. It shifts from public authorities to the industry the responsibility for ensuring that chemicals produced, imported, sold and used in the EU are safe. It also:

promotes alternative methods to animal testing,
creates a single market for chemicals,
aims to foster innovation and competitiveness in the sector,
establishes a European Chemicals Agency (ECHA).

Key Points

The legislation applies to all chemical substances: manufactured, imported, sold, used on their own, in mixtures or in products. Many can be found in our daily lives as cleaning products, paints or in electrical appliances.

Companies must register in a central database all chemicals which they manufacture or import in quantities of 1 tonne or more per year. The ECHA must check the information submitted in the registrations.
Companies must identify and manage any risks linked to the substances they manufacture and market in the EU. They must demonstrate how to use their products safely and inform users of any risk management measures they should take to ensure safe use throughout the supply chain.

National authorities may restrict the manufacture or use of certain substances if they consider that the risks are not adequately managed.

The legislation aims to replace the most hazardous substances by safer alternatives, where they are available.
The legislation does not apply to certain groups of substances (e.g. those that are radioactive or under customs supervision) or to waste, as these are already extensively regulated under other legislation.
In 2013, the European Commission assessed the first 5 years of the REACH regulation and concluded no major overhaul was required before the 1 June 2018 deadline for registering certain substances.

Application and Background

It has applied since 1 June 2007.

The chemicals industry is one of the EU’s largest manufacturing sectors. It plays a pivotal role in our daily lives and in the overall competitiveness of the economy. The EU has put in place legislation which enables the chemicals industry (also the broader manufacturing industry which uses chemicals) to develop and innovate, while at the same time ensuring its products are safe for people and the environment.

For more information, see:

Chemicals (European Commission)
REACH (European Commission).

MAIN DOCUMENT

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 136, 29.5.2007, pp. 3-280)

Successive amendments and changes to Regulation (EC) No 1907/2006 and its Annexes have been incorporated into the original text. This consolidated version is of documentary value only.

Safe medicines for Europeans — European Medicines Agency

Regulation (EC) No 726/2004 — procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

It seeks to guarantee high standards of quality and safety of medicines in the EU, and includes measures to encourage innovation and competitiveness.

It sets out procedures for authorising and supervising medicinal products for human and veterinary use and sets up the European Medicines Agency (EMA).

Key Points

The regulation introduces a centralised authorisation procedure for medicinal products in addition to existing national systems.

This centralised procedure is compulsory for:

products derived from biotechnology, i.e. the use of living organisms,
advanced therapy medicinal products, i.e. based on the manipulation of genes, cells or tissues,
orphan medicinal products, i.e. for the treatment of rare diseases, or
products containing any new substance to treat:
acquired immune deficiency syndrome (AIDS),
cancer,
neurodegenerative disorder,
diabetes, or
other immune disorders and viral diseases.

The procedure is optional where:

a new active substance is involved, or
an innovation is of interest at EU level.
Authorisation is based on quality, safety and efficacy, lasts for 5 years, and is renewable.

Veterinary products

Similar principles, with some adjustment, apply to products intended for veterinary use.

Authorisation may be refused on the grounds of health and welfare of animals or consumer safety, or if human food from treated animals could contain harmful residues.

Monitoring (Pharmacovigilance)

The regulation also reinforces monitoring procedures. EU countries must inform the EMA and the European Commission where the manufacturer or importer fails to fulfil their obligations under an authorisation.

Where urgent action is essential to protect human health or the environment, an EU country may suspend use of a medicinal product. The holder of the authorisation must notify the EMA, the Commission and other EU countries of any such variation or suspension.

The EMA administers the EudraVigilance database to collate monitoring information, reporting to the Commission, the European Parliament and the Council.

European Medicines Agency

The EMA, and its committees, comprise representatives from EU countries and expert advisors. It is responsible for:

scientific advice;
coordinating the evaluation of the quality, safety and efficacy of medicinal products, and coordinating monitoring systems;
keeping information on authorised medicinal products and potential adverse reactions;
assisting EU countries with communication with healthcare professionals;
creating a database on medicinal products accessible to the general public; and
advising on limits for residues of veterinary medicinal products.
EMA’s headquarters

Under Regulation (EU) 2018/1718, in the context of the United Kingdom’s intention to withdraw from the EU, the seat of the EMA is to be relocated from London to Amsterdam as of 30 March 2019.

Application & Background

It has applied since 20 May 2004 apart from certain rules which have applied since 20 November 2005 (Titles I, II, III and V) and 20 May 2008 (point 3, 5th and 6th indents of the annex).

For more information, see:

Medicinal products (European Commission)
Human medicines: regulatory information (EMA).

MAIN DOCUMENT

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1-33)

Successive amendments to Regulation (EC) No 726/2004 have been incorporated into the original text. This consolidated version is of documentary value only.

Agencies [EU]

European Chemicals Agency (ECHA)

Key Points

Application and Background

MAIN DOCUMENT

Safe medicines for Europeans — European Medicines Agency

Key Points

European Medicines Agency

Application & Background

MAIN DOCUMENT

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