29.5.

2007 EN Official Journal of the European Union L 136/3

CORRIGENDA

Corrigendum to 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

(Official Journal of the European Union L 396 of 30 December 2006)

Regulation (EC) No 1907/2006 should read as follows:

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 Direc-
tive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO- (3) A high level of human health and environmental protec-
PEAN UNION, tion should be ensured in the approximation of legisla-
tion on substances, with the goal of achieving sustainable
Having regard to the Treaty establishing the European Com- development. That legislation should be applied in a non-
munity, and in particular Article 95 thereof, discriminatory manner whether substances are traded on
the internal market or internationally in accordance with
the Community's international commitments.
Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and

Social Committee (1),
(4) Pursuant to the implementation plan adopted on
4 September 2002 at the Johannesburg World Summit
Having regard to the opinion of the Committee of the on sustainable development, the European Union is
Regions (2), aiming to achieve that, by 2020, chemicals are produced
and used in ways that lead to the minimisation of signifi-
Acting in accordance with the procedure laid down in cant adverse effects on human health and the environ-
Article 251 of the Treaty (3), ment.

Whereas:

(1) This Regulation should ensure a high level of protection (5) This Regulation should apply without prejudice to Com-
of human health and the environment as well as the free munity workplace and environment legislation.
movement of substances, on their own, in preparations
and in articles, while enhancing competitiveness and
innovation. This Regulation should also promote the
development of alternative methods for the assessment of
hazards of substances. (6) This Regulation should contribute to fulfilment of the
Strategic Approach to International Chemical Manage-
(2) The efficient functioning of the internal market for ment (SAICM) adopted on 6 February 2006 in Dubai.
substances can be achieved only if requirements for
substances do not differ significantly from Member State
to Member State.

(1) OJ C 112, 30.4.2004, p. 92 and OJ C 294, 25.11.2005, p. 38. (7) To preserve the integrity of the internal market and to
(2) OJ C 164, 5.7.2005, p. 78. ensure a high level of protection for human health, espe-
(3) Opinion of the European Parliament of 17 November 2005 (OJ C 280 E, cially the health of workers, and the environment, it is
18.11.2006, p. 303), Council Common Position of 27 June 2006 (OJ
C 276 E, 14.11.2006, p. 1) and Position of the European Parliament of necessary to ensure that manufacturing of substances in
13 December 2006 (not yet published in the Official Journal). Council the Community complies with Community law, even if
Decision of 18 December 2006. those substances are exported.
L 136/4 EN Official Journal of the European Union 29.5.2007

(8) Special account should be taken of the potential impact cases to ensure that substances of high concern are even-
of this Regulation on small- and medium-sized enter- tually replaced by less dangerous substances or technolo-
prises (SMEs) and the need to avoid any discrimination gies where suitable economically and technically viable
against them. alternatives are available. This Regulation does not affect
the application of Directives on worker protection and
the environment, especially Directive 2004/37/EC of the
European Parliament and of the Council of 29 April
2004 on the protection of workers from the risks related
(9) The assessment of the operation of the four main legal to exposure to carcinogens or mutagens at work
instruments governing chemicals in the Community, i.e. (Sixth individual Directive within the meaning of
Council Directive 67/548/EEC of 27 June 1967 on the Article 16(1) of Council Directive 89/391/EEC) (5) and
approximation of the laws, regulations and administrative Council Directive 98/24/EC of 7 April 1998 on the
provisions relating to the classification, packaging and protection of the health and safety of workers from the
labelling of dangerous substances (1), Council Direc- risks related to chemical agents at work (fourteenth indi-
tive 76/769/EEC of 27 July 1976 on the approximation vidual Directive within the meaning of Article 16(1) of
of the laws, regulations and administrative provisions of Directive 89/391/EEC) (6) under which employers are
the Member States relating to restrictions on the required to eliminate dangerous substances, wherever
marketing and use of certain dangerous substances and technically possible, or to substitute dangerous substances
preparations (2), Directive 1999/45/EC of the European with less dangerous substances.
Parliament and of the Council of 31 May 1999
concerning the approximation of the laws, regulations
and administrative provisions of the Member States
relating to the classification, packaging and labelling of
dangerous preparations (3) and Council Regulation (EEC)
No 793/93 of 23 March 1993 on the evaluation and (13) This Regulation should apply without prejudice to the
control of the risks of existing substances (4), identified a prohibitions and restrictions laid down in Council Direc-
number of problems in the functioning of Community tive 76/768/EEC of 27 July 1976 on the approximation
legislation on chemicals, resulting in disparities between of the laws of the Member States relating to cosmetic
the laws, regulations and administrative provisions in products (7) in so far as substances are used and marketed
Member States directly affecting the functioning of the as cosmetic ingredients and are within the scope of this
internal market in this field, and the need to do more to Regulation. A phase-out of testing on vertebrate animals
protect public health and the environment in accordance for the purpose of protecting human health as specified
with the precautionary principle. in Directive 76/768/EEC should take place with regard to
the uses of those substances in cosmetics.

(10) Substances under customs supervision which are in

temporary storage, in free zones or free warehouses with
a view to re-exportation or in transit are not used within (14) This Regulation will generate information on substances
the meaning of this Regulation and should therefore be and their uses. Available information, including that
excluded from its scope. The carriage of dangerous generated by this Regulation, should be used by the rele-
substances and of dangerous preparations by rail, road, vant actors in the application and implementation of
inland waterways, sea or air should also be excluded appropriate Community legislation, for example that
from its scope as specific legislation already applies to covering products, and Community voluntary instru-
such carriage. ments, such as the eco-labelling scheme. The Commission
should consider in the review and development of rele-
vant Community legislation and voluntary instruments
how information generated by this Regulation should be
used, and examine possibilities for establishing a Euro-
(11) To ensure workability and to maintain the incentives for pean quality mark.
waste recycling and recovery, wastes should not be
regarded as substances, preparations or articles within the
meaning of this Regulation.

(15) There is a need to ensure effective management of the

technical, scientific and administrative aspects of this
(12) An important objective of the new system to be estab- Regulation at Community level. A central entity should
lished by this Regulation is to encourage and in certain therefore be created to fulfil this role. A feasibility study
on the resource requirements for this central entity
(1) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission concluded that an independent central entity offered a
Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1). Corrected in OJ number of long-term advantages over other options. A
L 216, 16.6.2004, p. 3. European Chemicals Agency (hereinafter referred to as
2
( ) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission the Agency) should therefore be established.
Directive 2006/139/EC (OJ L 384, 29.12.2006, p. 94).
(3) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Commission
Directive 2006/8/EC (OJ L 19, 24.1.2006, p. 12). (5) OJ L 158, 30.4.2004, p. 50, corrected in OJ L 229, 29.6.2004, p. 23.
(4) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) (6) OJ L 131, 5.5.1998, p. 11.
No 1882/2003 of the European Parliament and of the Council (OJ (7) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission
L 284, 31.10.2003, p. 1). Directive 2007/1/EC (OJ L 25, 1.2.2007, p. 9).
29.5.2007 EN Official Journal of the European Union L 136/5

(16) This Regulation lays down specific duties and obligations turers and importers to manage the risks related to their
on manufacturers, importers and downstream users of substances, it may also be used to initiate the authorisa-
substances on their own, in preparations and in tion or restrictions procedures under this Regulation or
articles. This Regulation is based on the principle that risk management procedures under other Community
industry should manufacture, import or use substances legislation. Therefore it should be ensured that this infor-
or place them on the market with such responsibility and mation is available to the competent authorities and may
care as may be required to ensure that, under reasonably be used by them for the purpose of such procedures.
foreseeable conditions, human health and the environ-
ment are not adversely affected.

(22) The authorisation provisions should ensure the good

functioning of the internal market while assuring that the
(17) All available and relevant information on substances on risks from substances of very high concern are properly
their own, in preparations and in articles should be controlled. Authorisations for the placing on the market
collected to assist in identifying hazardous properties, and use should be granted by the Commission only if the
and recommendations about risk management measures risks arising from their use are adequately controlled,
should systematically be conveyed through supply chains, where this is possible, or the use can be justified for
as reasonably necessary, to prevent adverse effects on socio-economic reasons and no suitable alternatives are
human health and the environment. In addition, commu- available, which are economically and technically viable.
nication of technical advice to support risk management
should be encouraged in the supply chain, where appro-
priate.

(23) The restriction provisions should allow the manufac-

turing, placing on the market and use of substances
presenting risks that need to be addressed, to be made
(18) Responsibility for the management of the risks of subject to total or partial bans or other restrictions, based
substances should lie with the natural or legal persons on an assessment of those risks.
that manufacture, import, place on the market or use
these substances. Information on the implementation of
this Regulation should be easily accessible, in particular
for SMEs.
(24) In preparation for this Regulation, the Commission has
launched REACH Implementation Projects (RIPs), invol-
ving relevant experts from stakeholder groups. Some of
those projects aim at developing draft guidelines and
(19) Therefore, the registration provisions should require tools which should help the Commission, the Agency,
manufacturers and importers to generate data on the Member States, manufacturers, importers and down-
substances they manufacture or import, to use these data stream users of substances to fulfil, in concrete terms,
to assess the risks related to these substances and to their obligations under this Regulation. This work should
develop and recommend appropriate risk management enable the Commission and the Agency to make available
measures. To ensure that they actually meet these obliga- appropriate technical guidance, in due time, with regard
tions, as well as for transparency reasons, registration to the deadlines introduced by this Regulation.
should require them to submit a dossier containing all
this information to the Agency. Registered substances
should be allowed to circulate on the internal market.

(25) The responsibility to assess the risks and hazards of

substances should be given, in the first place, to the
natural or legal persons that manufacture or import
(20) The evaluation provisions should provide for follow-up substances, but only when they do so in quantities
to registration, by allowing for checks on whether regis- exceeding a certain volume, to enable them to carry the
trations are in compliance with the requirements of this associated burden. Natural or legal persons handling
Regulation and if necessary by allowing for generation of chemicals should take the necessary risk management
more information on the properties of substances. If the measures in accordance with the assessment of the risks
Agency in cooperation with the Member States considers of substances and pass on relevant recommendations
that there are grounds for considering that a substance along the supply chain. This should include describing,
constitutes a risk to human health or the environment, documenting and notifying in an appropriate and trans-
the Agency should, after having included the substance in parent fashion the risks stemming from the production,
the Community rolling action plan for substance evalua- use and disposal of each substance.
tion, relying on the competent authorities of Member
States, ensure that this substance is evaluated.

(26) In order to undertake chemical safety assessments of

substances effectively, manufacturers and importers of
(21) Although the information yielded on substances through substances should obtain information on these
evaluation should be used in the first place by manufac- substances, if necessary by performing new tests.
L 136/6 EN Official Journal of the European Union 29.5.2007

(27) For purposes of enforcement and evaluation and for (31) The Commission, in close cooperation with industry,
reasons of transparency, the information on these Member States and other relevant stakeholders, should
substances, as well as related information, including on develop guidance to fulfil the requirements under this
risk management measures, should normally be Regulation related to preparations (in particular with
submitted to authorities. regard to safety data sheets incorporating exposure
scenarios) including assessment of substances incorpo-
rated into special preparations — such as metals incorpo-
rated in alloys. In doing so, the Commission should take
full account of the work that will have been carried out
(28) Scientific research and development normally takes place within the framework of the RIPs and should include the
in quantities below one tonne per year. There is no need necessary guidance on this matter in the overall REACH
to exempt such research and development because guidance package. This guidance should be available
substances in those quantities do not have to be regis- before the application of this Regulation.
tered in any case. However, in order to encourage innova-
tion, product and process oriented research and develop-
ment should be exempted from the obligation to register
for a certain time period where a substance is not yet (32) A chemical safety assessment should not need to be
intended to be placed on the market to an indefinite performed for substances in preparations in certain very
number of customers because its application in prepara- small concentrations which are considered as not giving
tions or articles still requires further research and devel- rise to concern. Substances in preparations in such low
opment performed by the potential registrant himself or concentrations should also be exempt from authorisation.
in cooperation with a limited number of known custo- These provisions should apply equally to preparations
mers. In addition, it is appropriate to provide for a that are solid mixtures of substances until a specific
similar exemption to downstream users using the shape is given to such a preparation that transforms it
substance for the purposes of product and process into an article.
oriented research and development, provided that the
risks to human health and the environment are
adequately controlled in accordance with the require-
ments of legislation for the protection of workers and (33) Joint submission and the sharing of information on
the environment. substances should be provided for in order to increase
the efficiency of the registration system, to reduce costs
and to reduce testing on vertebrate animals. One of a
group of multiple registrants should submit information
on behalf of the others according to rules which ensure
(29) Since producers and importers of articles should be that all the required information is submitted, while
responsible for their articles, it is appropriate to impose a allowing sharing of the costs burden. A registrant should
registration requirement on substances which are be able to submit information directly to the Agency in
intended to be released from articles and have not been certain specified cases.
registered for that use. In the case of substances of very
high concern which are present in articles above tonnage
and concentration thresholds, where exposure to the
substance cannot be excluded and where the substance (34) Requirements for generation of information on
has not been registered by any person for this use, the substances should be tiered according to the volumes of
Agency should be notified. The Agency should also be manufacture or importation of a substance, because these
empowered to request that a registration be submitted if provide an indication of the potential for exposure of
it has grounds for suspecting that the release of a man and the environment to the substances, and should
substance from the article may present a risk to human be described in detail. To reduce the possible impact on
health or the environment and the substance is present low volume substances, new toxicological and ecotoxico-
in those articles in quantities totalling over one tonne per logical information should only be required for priority
producer or importer per year. The Agency should substances between 1 and 10 tonnes. For other
consider the need for a proposal for a restriction where it substances in that quantity range there should be incen-
considers that the use of such substances in articles poses tives to encourage manufacturers and importers to
a risk to human health or the environment that is not provide this information.
adequately controlled.

(35) The Member States, the Agency and all interested parties
should take full account of the results of the RIPs, in par-
(30) The requirements for undertaking chemical safety assess- ticular with regard to the registration of substances which
ments by manufacturers and importers should be defined occur in nature.
in detail in a technical annex to allow them to meet their
obligations. To achieve fair burden sharing with their
customers, manufacturers and importers should in their
chemical safety assessment address not only their own (36) It is necessary to consider the application of Article 2(7)
uses and the uses for which they place their substances (a) and (b) and Annex XI to substances derived from
on the market, but also all uses which their customers mineralogical processes and the review of Annexes IV
ask them to address. and V should fully take this into account.