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REACH (Registration, Evaluation, Authorisation and Restriction of Chemical substances)

REACH is a new European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The new law entered into force on 1 June 2007.

The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced. The benefits of the REACH system will come gradually, as more and more substances are phased into REACH.

The REACH Regulation gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers will be required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database run by the European Chemicals Agency (ECHA) in Helsinki. The Agency will act as the central point in the REACH system: it will manage the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals and run a public database in which consumers and professionals can find hazard information.

The Regulation also calls for the progressive substitution of the most dangerous chemicals when suitable alternatives have been identified. For more information read: REACH in Brief.

REACH has been developed in a climate of transparency and consultation. The Commission has held extensive dialogue with stakeholders before and after the proposal was presented. Stakeholders sent over 6000 responses during the REACH internet consultation and contributed to the REACH Impact Assessment both before and after the launch of the Commission REACH proposal in 2003. This helped the Commission to improve the design and cost-effectiveness of the system and subsequently the European Parliament and the Council of the European Union to amend the proposal under the co-decision procedure.

REACH provisions will be phased-in over 11 years. Companies can find explanations of REACH in the guidance documents and can address themselves to a number of helpdesks.

The Commission will carry out a number of reviews of REACH Annexes within 18 months after entry into force (Annexes I, IV, V, XI, XIII).

Article 33 of REACH regulation (EC No.1907/2006) requires article suppliers to inform recipients in the supply chain if their article contains substance of very high concern (SVHC) over 0.1% w/w. Upon consumer requests, article suppliers have to provide SVHC safe use information within 45 days free of charge. The European Chemical Agency (ECHA) published the first list of SVHC candidate list on Oct 28, 2008 which included 15 substances. This list is updated regularly in accordance with a defined procedures, the new update of the list was in January 2010. ECHA’s Member State Committee agreed unanimously in early December 2009 that 15 new SVHC are to be included in the candidate list.

SVHCs are substances with properties known to be hazardous to human health and the environment, such as substances that cause cancer or genetic mutation or that are toxic to animals and plants. Companies must disclose the presence of any of these substances in their product to customers. Later, SVHCs may only be used in certain applications or products, under authorization by EU Authorities.

29. Lead chromate molybdate sulphate red (C.I. Pigment Red 104) (CAS No. 12656-85-8)

Article 7 of REACH details the criteria under which a SVHC would need to be notified to the European Chemicals Agency (ECHA) if it is present in an article (product). In summary, notification would be required if:
(a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year, and;
(b) the substance is present in those articles above a concentration of 0.1 % weight by weight (of article).

Notification is not required, however, if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal. (in such cases, the producer or importer shall supply appropriate instructions to the recipient of the article.) or if the substance has already been registered for that use.

The SVHC's that may require notification will be named on the so called “candidate list” which should be published on the ECHA website towards the end of this year or, more likely, early next year. Such notifications will not be required until June 2011 at the earliest.

Authorisation:
Substances that require authorisation will be published as Annex XIV of REACH. This will be developed from a list of proposed substances for authorisation which will be drawn from the "candidate list" mentioned above but is likely to be much smaller. This proposed list will be published on the ECHA website by June 2009. If a substance eventually appears on Annex XIV it will require authorisation irrespective of the tonnages involved.

Any substance that falls into this category will require a safety data sheet to be provided to all the recipients of the substance or preparation containing the substance.

As per the REACH Regulation, all chemical substances that are manufactured in or imported in the EU in the quantity of more than 1 ton/year need to be registered with the EU Chemicals Agency (ECHA). The new law, which entered into force from 1st June 2007,effects all manufacturers, importers, retailers, brand managers, distributors of chemical substances or products in the EU, across industries as wide as electrical and electronics, aerospace and automotive, metals, plastics, textiles / garments, accessories, toys & many other consumer good industries.

The pre-registration of chemicals began in 1st June 2008. The subsequent registration will be carried out over the course of 11 years in three stages, and ultimately unregistered substances will no longer be able to be produced or imported into the EU.

Legislative texts of REACH

Regulation (EC) No 1907/2006 is the central act of the new European chemicals policy. It is often referred to as the "REACH Regulation".

Directive 2006/121/EC contains technical adaptations of Directive 67/548/EEC that are necessary in the light of the new REACH Regulation (Directive 67/548 concerns the classification, packaging and labelling of dangerous substances and applies in parallel with REACH).

Within the first 18 months after the entry into force of REACH (Regulation (EC) No. 1907/2006), the Commission has been tasked to carry out a number of reviews of the following Annexes of the Regulation:

The Commission will involve Member States and other stakeholders on the reviews in a sub-group of the REACH Competent Authorities.

Following the reviews, and if appropriate, the Commission will prepare amendments to the relevant Annexes to take into account the results of the reviews.

The Commission engaged Member States and other stakeholders on the reviews in a sub-group of the REACH Competent Authorities (CA); the Competent Authority Sub Group for the Annexes (CASG (Annexes)).

The Commission asked for nominations by CA members and observers to enable consultation covering all the reviews. The following Member States: AT, BE, DE, DK, EE, IE, LT, NL, SE,

UK, and observers:

Norway, CEFIC, REACH Alliance, CONCAWE, WWF and ETUC, were nominated and selected.

The proposals for inclusion in/deletion of substances from Annex IV are governed by a separate procedure (see text on Annex IV below). Stakeholder's comments concerning the review of other Annexes should preferably be co-ordinated and channelled through these members and observers with a copy to the Commission services (ENV-REACH-annexes@ec.europa.eu and ENTR-REACH-Annexes@ec.europa.eu).

Annex I of Annex IV of Regulation (EC) No. 1907/2006 (REACH) sets out the details of how to carry out a Chemical Safety Assessment and document it in a Chemical Safety Report. The Annex will be supplemented by a technical guidance document (currently being developed under Reach Implementation Project (RIP) 3.2).

Article 138(4) mandates the Commission to carry out a review of Annex I of REACH by 1 June 2008. Depending on the outcome of the review, the Commission may, if appropriate, produce proposals for amending the Annex by Comitology through the regulatory procedure with scrutiny.

Annex IV of Regulation (EC) No. 1907/2006 (REACH) sets out substances that are exempted from the registration, evaluation and downstream user provisions of REACH because sufficient information is known about the substances that they are considered to cause minimum risk because of their intrinsic properties.

Substances included in Annex IV are exempted from registration (as well as downstream user requirements and evaluation) for all their possible uses irrespective of the tonnage they are manufactured or imported (currently or in the future). Annex IV essentially reproduces the list of substances exempt from the obligation to register under the present Existing Substances Regulation (Regulation (EEC) No. 793/93).

Article 138(4) mandates the Commission to carry out a review of Annex IV of REACH before 1 June 2008 and, if required, the Commission also has to produce proposals for amending the Annex by Comitology through the regulatory procedure with scrutiny. Recital 36 also requires the review of Annex IV to take into account the application of Annex IV and Annex XI to substances derived from mineralogical processes.

The Commission has agreed with the Member States and stakeholders a process for submission of proposals for amendments to Annex IV, criteria against which the proposals for amendment can be judged, documentation that should be provided and a timetable for completing this work. In this context, proposals for the inclusion in/deletion of substances from Annex IV can be made to Member States Competent Authorities and a number of Industry Associations by 30 November 2007, respecting the criteria and documentation requirements mentioned above. The relevant document can be found here.

Annex XI sets out the general rules for adaptation of the standard testing regime (waiving) specified in the information Annexes. Part 3 of Annex XI deals with substance-tailored exposure-driven testing for sections 8.6 and 8.7 of Annex VIII, Annex IX and Annex X, where, on the basis of the exposure scenario(s) developed in the Chemical Safety Report, testing may be waived.

The Commission was given the task to adopt by 1 December 2008 easily applicable criteria defining what constitutes adequate justification for waiving tests. Recital 38 gives guidance that the criteria should be based on experience gained through RIPs.

The review will depend on the outcome of, in particular, RIP 3.2 on Chemical Safety Assessment and RIP 3.3 on Information Requirements. This means in practice that the review will not be progressed before the end of 2007.

Annex XIII sets out the criteria for the identification of persistent, bioaccumulative and toxic (PBT) substances, and very persistent and very bioaccumulative (vPvB) substances; it does not apply to inorganic substances.

Article 138(5) mandates the Commission to carry out a review of Annex XIII by 1 December 2008.

The review will depend on the outcome of, in particular, RIP 3.2 on Chemical Safety Assessment (PBT working group) and RIP 3.3 on Information Requirements. This means in practice that the review will not be progressed before the end of 2007.

REACH: History and Background

History of the adoption process for the new chemicals legislation

On 13th February, 2001, the European Commission adopted a White Paper setting out the strategy for a future Community Policy for Chemicals.

The European Commission's original legislative proposal on REACH COM(03) 644 (01) and COM(03) 644 (02) amending Directive 67/548/EEC was adopted on 29 October 2003 and was communicated to both the European Parliament and the Council in November 2003.

The work in the European Parliament has been led by the Committee on the Environment, Public Health & Food Safety, with – in first reading - the assistance of nine other parliamentary committees. The European Parliament adopted its first reading opinion on 17 November 2005.

The Environment Council formally adopted the Common Position (pdf 1,7MB) (press release - pdf 312KB) on June 2006 which served as the basis of discussion during the second reading in the European Parliament, which started in September 2006.

A Commission Communication on the Common Position (COM (2006) 375) was adopted on 12 July 2006 and submitted to the European Parliament and Council allowing the second reading to commence.

The representatives of the European Parliament and the Council found a negotiated agreement of the final version of REACH in early December 2006. This agreement was subsequently endorsed at second reading in the European Parliament on 13 December 2006 (press release) and got finally adopted at the Environment Council on 18 December 2006 (press release).

The new EU chemicals Regulation REACH entered into force on 1 June 2007 (press release). The new European Chemicals Agency in Helsinki,

Finland, will be fully operational on 1 June 2008, in time for the industry's obligation to submit pre-registration dossiers for existing substances and registration dossiers for new substances.