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.
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.
also calls for the progressive substitution of the most dangerous chemicals
when suitable alternatives have been identified. For more information read: REACH in
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
will be phased-in over 11 years. Companies can find explanations of REACH in
documents and can address themselves to a number of helpdesks.
will carry out a number of reviews of
REACH Annexes within 18 months after entry into force (Annexes I,
IV, V, XI, XIII).
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.
of Very High Concern (SVHC):
Cobalt dichloride (CAS No. 7646-79-9)
(CAS No. 15606-95-8)
Bis(tributyltin) oxide (CAS No. 56-35-9)
(CAS No. 10588-01-9)
Dibutyl phthalate (DBP
(CAS No. 84-74-2)
Musk xylene (CAS No. 81-15-2)
7. Diarsenic pentaoxide
(CAS No. 1303-28-2)
(CAS No. 117-81-7)
Alkanes, C10-13, chloro (SCCPs)
(CAS No. 85535-84-8)
10. Diarsenic trioxide
(CAS No. 1327-53-3)
Benzyl butyl phthalate (BBP)
(CAS No. 85-68-7)
Hexabromocyclododecane (HBCDD) and all major diastereoisomers
No. 25637-99-4; 3194-55-6
(134237-50-6; 51-7; 52-8)]
Lead hydrogen arsenate
(CAS No. 7784-40-9)
4,4’-Diaminodiphenyl methane (MDA)
(CAS No. 101-77-9)
(CAS No. 120-12-7)
(CAS No. 79-06-1)
17. Diisobutyl phthalate
(CAS No. 84-69-5)
(CAS No. 121-14-2)
(CAS No. 115-96-8)
20. Anthracene oil
(CAS No. 90640-80-5)
Anthracene oil, anthracene paste, distn. Lights
(CAS No. 91995-17-4)
Anthracene oil, anthracene paste, anthracene fraction
(CAS No. 91995-15-2)
Anthracene oil, anthracene-low
(CAS No. 90640-82-7)
Anthracene oil, anthracene paste
(CAS No. 90640-81-6)
Coal tar pitch, high temperature
(CAS No. 65996-93-2)
Aluminosilicate, Refractory Ceramic Fibres
(CAS No. 650-017-00-8)
Zirconia Aluminosilicate, Refractory Ceramic Fibres
(CAS No. 650-017-00-8)
Lead sulfochromate yellow (C.I. Pigment Yellow 34)
(CAS No. 1344-37-2)
Lead chromate molybdate sulphate red (C.I. Pigment Red 104)
(CAS No. 12656-85-8)
30. Lead chromate
(CAS No. 7758-97-6)
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;
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.
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.
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
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
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).
Commission review of Annexes I, IV, V, XI and XIII of
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 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-REACHemail@example.com
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.
The scoping of the issues by the
Commission is currently ongoing.
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
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
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.
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
reached a Political Agreement for a Common Position (pdf 865KB) on 13 December 2005.
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.
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.
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 text of the
law was published on 30 December 2006 in the Official Journal of the European Union L 396.
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.
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