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16.3.2011 Official
Journal
of
the
European
Union
L
69/3
REGULATIONS
COMMISSION REGULATION (EU) No 252/2011
of 15 March 2011
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex I
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
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 ( 4 )
were amended several times. Directives 67/548/EEC and
Having regard to the Treaty on the Functioning of the European
1999/45/EC will be replaced over a transitional period
Union,
according to which substances must be classified, labelled
and packaged according to Regulation (EC) No
1272/2008 from 1 December 2010 and mixtures from
1 June 2015, although from 1 December 2010 until
1 June 2015 classification of substances according to
Having regard to Regulation (EC) No 1907/2006 of the
both Directive 67/548/EEC and Regulation (EC) No
European Parliament and of the Council of 18 December
1272/2008 is required. Both Directives will be repealed
2006 concerning the Registration, Evaluation, Authorisation
in full by Regulation (EC) No 1272/2008 with effect
and Restriction of Chemicals (REACH), establishing a
from 1 June 2015.
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 ( 1 ), and in particular
(3) Annex
I
to
Regulation
(EC)
No
1907/2006
should
be
Article 131 thereof,
amended to adapt it to the criteria for classification
and other relevant provisions laid down in Regulation
(EC) No 1272/2008.
Whereas:
(4) Article
58(1)
of
Regulation
(EC)
No
1272/2008
modifies
Article 14(4) of Regulation (EC) No 1907/2006 to adapt
it to the classification criteria in Regulation (EC) No
(1) Regulation
(EC)
No
1272/2008
of
the
European
1272/2008. This also has consequences for Annex I to
Parliament and of the Council of 16 December 2008
Regulation (EC) No 1907/2006, which was not amended
on classification, labelling and packaging of substances
by Regulation (EC) No 1272/2008. It is therefore
and mixtures, amending and repealing Directives
necessary to adapt Annex I to Regulation (EC) No
67/548/EEC and 1999/45/EC, and amending Regulation
1907/2006 to the new text in its Article 14(4).
(EC) No 1907/2006 ( 2 ) harmonises the provisions and
criteria for the classification and labelling of substances,
mixtures and certain specific articles within the
Community, taking into account the classification
criteria and labelling rules of the Globally Harmonised
(5) Regulation
(EC)
No
1272/2008
introduces
substantive
System of Classification and Labelling of Chemicals.
changes in terminology compared to those used in
Directive 67/548/EEC. Annex I to Regulation (EC) No
1907/2006 was not amended by Regulation (EC) No
1272/2008 and should be updated to reflect these
changes and ensure consistency throughout.
(2) Council
Directive
67/548/EEC
of
27
June
1967
on
the
approximation of the laws, regulations and administrative
provisions relating to the classification, packaging and
labelling of dangerous substances
( 3 ) and Directive
1999/45/EC of the European Parliament and of the
(6) Furthermore,
references
to
Directive
67/548/EEC
should
be replaced by appropriate references to Regulation (EC)
No 1272/2008.
( 1 ) OJ L 396, 30.12.2006, p. 1.
( 2 ) OJ L 353, 31.12.2008, p. 1.
( 3 ) OJ 196, 16.8.1967, p. 1.
( 4 ) OJ L 200, 30.7.1999, p. 1.

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L 69/4
EN
Official Journal of the European Union
16.3.2011
(7) In
accordance
with
Regulation
(EC)
No
1907/2006,
and 6 in accordance with Sections 5 and 6 of this
registrations including chemical safety reports will have
Annex:
been submitted by the date of application of this Regu
lation. Changes in classification criteria and other relevant
(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8
provisions resulting from Regulation (EC) No 1272/2008
types A and B, 2.9, 2.10, 2.12, 2.13 categories
apply to substances from 1 December 2010, in
1 and 2, 2.14 categories 1 and 2, and 2.15 types
accordance with the second paragraph of Article 62 of
A to F;
that Regulation. In order to ensure a smooth transition
for the updating of registrations, a transitional period
(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on
should be provided.
sexual function and fertility or on development,
3.8 effects other than narcotic effects, 3.9, and
(8) Annex
I
to
Regulation
(EC)
No
1907/2006
should
3.10;
therefore be amended accordingly.
(c) hazard class 4.1;
(9) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Committee estab
(d) hazard class 5.1.
lished pursuant to Article 133 of Regulation (EC) No
1907/2006,
0.6.4. A summary of all the relevant information used in
addressing the points above shall be presented under
HAS ADOPTED THIS REGULATION:
the relevant heading of the Chemical Safety Report
(Section 7).’;
Article 1
2. point 1.0.1 is replaced by the following:
Annex I to Regulation (EC) No 1907/2006 is amended as
follows:
‘1.0.1. The objectives of the human health hazard
assessment shall be to determine the classification
1. point 0.6 is replaced by the following:
of a substance in accordance with Regulation (EC)
No 1272/2008; and to derive levels of exposure to
‘0.6. Steps
of
a
chemical
safety
assessment
the substance above which humans should not be
0.6.1. A chemical safety assessment performed by a manu
exposed. This level of exposure is known as the
facturer or an importer for a substance shall include
Derived No-Effect Level (DNEL).’;
the following steps 1 to 4 in accordance with the
respective sections of this Annex:
3. point 1.0.2 is replaced by the following:
1. Human health hazard assessment.
‘1.0.2. The human health hazard assessment shall consider
the toxicokinetic profile (i.e. absorption,
2. Human health hazard assessment of physico
metabolism, distribution and elimination) of the
chemical properties.
substance and the following groups of effects:
(1) acute effects such as acute toxicity, irritation
3. Environmental hazard assessment.
and corrosivity;
4. PBT and vPvB assessment.
(2) sensitisation;
0.6.2. In the cases referred to in point 0.6.3 the chemical
(3) repeated dose toxicity; and
safety assessment shall also include the following
steps 5 and 6 in accordance with Sections 5 and
(4) CMR effects (carcinogenity, germ cell mutage
6 of this Annex:
nicity and toxicity for reproduction).
5. Exposure
assessment.
Based on all the available information, other effects
shall be considered when necessary.’;
5.1. The generation of exposure scenario(s) (or the
identification of relevant use and exposure
4. point 1.1.3 is replaced by the following:
categories, if appropriate).
‘1.1.3. All non-human information used to assess a
5.2. Exposure estimation.
particular effect on humans and to establish the
dose (concentration) – response (effect) relationship,
6. Risk
characterisation.
shall be briefly presented, if possible in the form of
a table or tables, distinguishing between in vitro, in
0.6.3. Where as a result of steps 1 to 4 the manufacturer
vivo and other information. The relevant test results
or importer concludes that the substance fulfils the
(e.g. ATE, LD50, NO(A)EL or LO(A)EL) and test
criteria for any of the following hazard classes or
conditions (e.g. test duration, route of adminis
categories set out in Annex I to Regulation (EC) No
tration) and other relevant information shall be
1272/2008 or is assessed to be a PBT or vPvB, the
presented, in internationally recognised units of
chemical safety assessment shall also include steps 5
measurement for that effect.’;

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EN
16.3.2011 Official
Journal
of
the
European
Union
L
69/5
5. points 1.3.1 and 1.3.2 are replaced by the following:
10. point 3.0.1 is replaced by the following:
‘1.3.1. The appropriate classification developed in
accordance with the criteria in Regulation (EC) No
‘3.0.1. The objective of the environmental hazard
1272/2008 shall be presented and justified. Where
assessment shall be to determine the classification
applicable, Specific Concentration limits resulting
of a substance in accordance with Regulation (EC)
from the application of Article 10 of Regulation
No 1272/2008 and to identify the concentration of
(EC) No 1272/2008 and Articles 4 to 7 of
the substance below which adverse effects in the
Directive 1999/45/EC shall be presented and, if
environmental sphere of concern are not expected
they are not included in Part 3 of Annex VI to
to occur. This concentration is known as the
Regulation (EC) No 1272/2008, justified.
Predicted No-Effect Concentration (PNEC).’;
The assessment should always include a statement
11. points 3.2.1 and 3.2.2 are replaced by the following:
as to whether the substance fulfils or does not fulfil
the criteria given in Regulation (EC) No 1272/2008
for classification in the hazard class carcinogenicity
‘3.2.1. The appropriate classification developed in
category 1A or 1B, in the hazard class germ cell
accordance with the criteria in Regulation (EC) No
mutagenicity category 1A or 1B or in the hazard
1272/2008 shall be presented and justified. Any M-
class reproductive toxicity category 1A or 1B.
factor resulting from the application of Article 10
of Regulation (EC) No 1272/2008 shall be
1.3.2. If the information is inadequate to decide whether a
presented and, if it is not included in Part 3 of
substance should be classified for a particular
Annex VI to Regulation (EC) No 1272/2008,
hazard class or category, the registrant shall
justified.
indicate and justify the action or decision he has
taken as a result.’;
3.2.2. If the information is inadequate to decide whether a
substance should be classified for a particular
6. the second sentence of point 1.4.1 is replaced by the
hazard class or category, the registrant shall
following:
indicate and justify the action or decision he has
taken as a result.’;
‘For some hazard classes, especially germ cell mutagenicity
and carcinogenicity, the available information may not
enable a toxicological threshold, and therefore a DNEL, to
12. points 4.1 and 4.2 are replaced by the following:
be established.’;
‘4.1. Step 1: Comparison with the criteria
7. point 2.1 is replaced by the following:
This part of the PBT and vPvB assessment shall entail
the comparison of the available information with the
‘2.1. The objective of the hazard assessment for physico
criteria given in Section 1 of Annex XIII and a
chemical properties shall be to determine the classifi
statement of whether the substance fulfils or does
cation of a substance in accordance with Regulation
not fulfil the criteria. The assessment shall be
(EC) No 1272/2008.’;
conducted in accordance with the provisions laid
down in the introductory part of Annex XIII as
8. point 2.2 is replaced by the following:
well as Sections 2 and 3 of that Annex.
‘2.2. As a minimum, the potential effects to human health
shall be assessed for the following physicochemical
4.2. Step 2: Emission Characterisation
properties:
If the substance fulfils the criteria or it is considered as
if it is a PBT or vPvB in the registration dossier an
— explosivity,
emission characterisation shall be conducted
comprising the relevant parts of the exposure
— flammability,
assessment as described in Section 5. In particular it
shall contain an estimation of the amounts of the
— oxidising potential.
substance released to the different environmental
compartments during all activities carried out by the
manufacturer or importer and all identified uses, and
If the information is inadequate to decide whether a
an identification of the likely routes by which humans
substance should be classified for a particular hazard
and the environment are exposed to the substance.’;
class or category, the registrant shall indicate and
justify the action or decision he has taken as a result.’;
13. Part B of the table in Section 7 is amended as follows:
9. point 2.5 is replaced by the following:
(a) points 5.3.1, 5.3.2 and 5.3.3 are deleted;
‘2.5. The appropriate classification developed in
accordance with the criteria in Regulation (EC) No
1272/2008 shall be presented and justified.’;
(b) points 5.5.1 and 5.5.2 are deleted;

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L 69/6
EN
Official Journal of the European Union
16.3.2011
(c) point 5.7 is replaced by the following:
However, for registrations submitted prior to 5 May 2011, the
chemical safety report shall be updated in accordance with this
‘5.7. Germ cell mutagenicity’;
Regulation by 30 November 2012 at the latest. Article 22(5) of
Regulation (EC) No 1907/2006 shall not apply to those
(d) points 5.9.1 and 5.9.2 are deleted.
updates.
Article 2
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
This Article is without prejudice to Articles 2 and 3 of
Commission Regulation (EU) No 253/2011 ( 1 ), with regard to
It shall apply from 5 May 2011.
Article 1(12) of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 March 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) See page 7 of this Official Journal.

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