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,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard 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 (  1 ), and in particular 
Article 131 thereof,  
Whereas:  
(1) Regulation (EC) No 1272/2008 of the European 
Parliament and of the Council of 16 December 2008 
on classification, labelling and packaging of substances 
and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation 
(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 
System of Classification and Labelling of Chemicals.  
(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 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 
1999/45/EC will be replaced over a transitional period 
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 
both Directive 67/548/EEC and Regulation (EC) No 
1272/2008 is required. Both Directives will be repealed 
in full by Regulation (EC) No 1272/2008 with effect 
from 1 June 2015.  
(3) Annex I to Regulation (EC) No 1907/2006 should be 
amended to adapt it to the criteria for classification 
and other relevant provisions laid down in Regulation 
(EC) No 1272/2008.  
(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 
1272/2008. This also has consequences for Annex I to 
Regulation (EC) No 1907/2006, which was not amended 
by Regulation (EC) No 1272/2008. It is therefore 
necessary to adapt Annex I to Regulation (EC) No 
1907/2006 to the new text in its Article 14(4).  
(5) Regulation (EC) No 1272/2008 introduces substantive 
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.  
(6) Furthermore, references to Directive 67/548/EEC should 
be replaced by appropriate references to Regulation (EC) 
No 1272/2008.EN 16.3.2011 Official Journal of the European Union L 69/3  
( 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.(7) In accordance with Regulation (EC) No 1907/2006, 
registrations including chemical safety reports will have 
been submitted by the date of application of this Regu ­
lation. Changes in classification criteria and other relevant 
provisions resulting from Regulation (EC) No 1272/2008 
apply to substances from 1 December 2010, in 
accordance with the second paragraph of Article 62 of 
that Regulation. In order to ensure a smooth transition 
for the updating of registrations, a transitional period 
should be provided.  
(8) Annex I to Regulation (EC) No 1907/2006 should 
therefore be amended accordingly.  
(9) The measures provided for in this Regulation are in 
accordance with the opinion of the Committee estab ­
lished pursuant to Article 133 of Regulation (EC) No 
1907/2006,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex I to Regulation (EC) No 1907/2006 is amended as 
follows:  
1. point 0.6 is replaced by the following:  
‘0.6. Steps of a chemical safety assessment  
0.6.1. A chemical safety assessment performed by a manu ­
facturer or an importer for a substance shall include 
the following steps 1 to 4 in accordance with the 
respective sections of this Annex:  
1. Human health hazard assessment.  
2. Human health hazard assessment of physico ­
chemical properties.  
3. Environmental hazard assessment.  
4. PBT and vPvB assessment.  
0.6.2. In the cases referred to in point 0.6.3 the chemical 
safety assessment shall also include the following 
steps 5 and 6 in accordance with Sections 5 and 
6 of this Annex:  
5. Exposure assessment.  
5.1. The generation of exposure scenario(s) (or the 
identification of relevant use and exposure 
categories, if appropriate).  
5.2. Exposure estimation.  
6. Risk characterisation.  
0.6.3. Where as a result of steps 1 to 4 the manufacturer 
or importer concludes that the substance fulfils the 
criteria for any of the following hazard classes or 
categories set out in Annex I to Regulation (EC) No 
1272/2008 or is assessed to be a PBT or vPvB, the 
chemical safety assessment shall also include steps 5 and 6 in accordance with Sections 5 and 6 of this 
Annex:  
(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 
types A and B, 2.9, 2.10, 2.12, 2.13 categories 
1 and 2, 2.14 categories 1 and 2, and 2.15 types 
A to F;  
(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on 
sexual function and fertility or on development, 
3.8 effects other than narcotic effects, 3.9, and 
3.10;  
(c) hazard class 4.1;  
(d) hazard class 5.1.  
0.6.4. A summary of all the relevant information used in 
addressing the points above shall be presented under 
the relevant heading of the Chemical Safety Report 
(Section 7).’;  
2. point 1.0.1 is replaced by the following:  
‘1.0.1. The objectives of the human health hazard 
assessment shall be to determine the classification 
of a substance in accordance with Regulation (EC) 
No 1272/2008; and to derive levels of exposure to 
the substance above which humans should not be 
exposed. This level of exposure is known as the 
Derived No-Effect Level (DNEL).’;  
3. point 1.0.2 is replaced by the following:  
‘1.0.2. The human health hazard assessment shall consider 
the toxicokinetic profile (i.e. absorption, 
metabolism, distribution and elimination) of the 
substance and the following groups of effects:  
(1) acute effects such as acute toxicity, irritation 
and corrosivity;  
(2) sensitisation;  
(3) repeated dose toxicity; and  
(4) CMR effects (carcinogenity, germ cell mutage ­
nicity and toxicity for reproduction).  
Based on all the available information, other effects 
shall be considered when necessary.’;  
4. point 1.1.3 is replaced by the following:  
‘1.1.3. All non-human information used to assess a 
particular effect on humans and to establish the 
dose (concentration) – response (effect) relationship, 
shall be briefly presented, if possible in the form of 
a table or tables, distinguishing between  in vitro , in 
vivo and other information. The relevant test results 
(e.g. ATE, LD50, NO(A)EL or LO(A)EL) and test 
conditions (e.g. test duration, route of adminis ­
tration) and other relevant information shall be 
presented, in internationally recognised units of 
measurement for that effect.’;EN L 69/4 Official Journal of the European Union 16.3.20115. points 1.3.1 and 1.3.2 are replaced by the following:  
‘1.3.1. The appropriate classification developed in 
accordance with the criteria in Regulation (EC) No 
1272/2008 shall be presented and justified. Where 
applicable, Specific Concentration limits resulting 
from the application of Article 10 of Regulation 
(EC) No 1272/2008 and Articles 4 to 7 of 
Directive 1999/45/EC shall be presented and, if 
they are not included in Part 3 of Annex VI to 
Regulation (EC) No 1272/2008, justified.  
The assessment should always include a statement 
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 
category 1A or 1B, in the hazard class germ cell 
mutagenicity category 1A or 1B or in the hazard 
class reproductive toxicity category 1A or 1B.  
1.3.2. If the information is inadequate to decide whether a 
substance should be classified for a particular 
hazard class or category, the registrant shall 
indicate and justify the action or decision he has 
taken as a result.’;  
6. the second sentence of point 1.4.1 is replaced by the 
following:  
‘For some hazard classes, especially germ cell mutagenicity 
and carcinogenicity, the available information may not 
enable a toxicological threshold, and therefore a DNEL, to 
be established.’;  
7. point 2.1 is replaced by the following:  
‘2.1. The objective of the hazard assessment for physico ­
chemical properties shall be to determine the classifi ­
cation of a substance in accordance with Regulation 
(EC) No 1272/2008.’;  
8. point 2.2 is replaced by the following:  
‘2.2. As a minimum, the potential effects to human health 
shall be assessed for the following physicochemical 
properties:  
— explosivity,  
— flammability,  
— oxidising potential.  
If the information is inadequate to decide whether a 
substance should be classified for a particular hazard 
class or category, the registrant shall indicate and 
justify the action or decision he has taken as a result.’;  
9. point 2.5 is replaced by the following:  
‘2.5. The appropriate classification developed in 
accordance with the criteria in Regulation (EC) No 
1272/2008 shall be presented and justified.’;  10. point 3.0.1 is replaced by the following:  
‘3.0.1. The objective of the environmental hazard 
assessment shall be to determine the classification 
of a substance in accordance with Regulation (EC) 
No 1272/2008 and to identify the concentration of 
the substance below which adverse effects in the 
environmental sphere of concern are not expected 
to occur. This concentration is known as the 
Predicted No-Effect Concentration (PNEC).’;  
11. points 3.2.1 and 3.2.2 are replaced by the following:  
‘3.2.1. The appropriate classification developed in 
accordance with the criteria in Regulation (EC) No 
1272/2008 shall be presented and justified. Any M- 
factor resulting from the application of Article 10 
of Regulation (EC) No 1272/2008 shall be 
presented and, if it is not included in Part 3 of 
Annex VI to Regulation (EC) No 1272/2008, 
justified.  
3.2.2. If the information is inadequate to decide whether a 
substance should be classified for a particular 
hazard class or category, the registrant shall 
indicate and justify the action or decision he has 
taken as a result.’;  
12. points 4.1 and 4.2 are replaced by the following:  
‘4.1.  Step 1: Comparison with the criteria  
This part of the PBT and vPvB assessment shall entail 
the comparison of the available information with the 
criteria given in Section 1 of Annex XIII and a 
statement of whether the substance fulfils or does 
not fulfil the criteria. The assessment shall be 
conducted in accordance with the provisions laid 
down in the introductory part of Annex XIII as 
well as Sections 2 and 3 of that Annex.  
4.2.  Step 2: Emission Characterisation  
If the substance fulfils the criteria or it is considered as 
if it is a PBT or vPvB in the registration dossier an 
emission characterisation shall be conducted 
comprising the relevant parts of the exposure 
assessment as described in Section 5. In particular it 
shall contain an estimation of the amounts of the 
substance released to the different environmental 
compartments during all activities carried out by the 
manufacturer or importer and all identified uses, and 
an identification of the likely routes by which humans 
and the environment are exposed to the substance.’;  
13. Part B of the table in Section 7 is amended as follows:  
(a) points 5.3.1, 5.3.2 and 5.3.3 are deleted;  
(b) points 5.5.1 and 5.5.2 are deleted;EN 16.3.2011 Official Journal of the European Union L 69/5(c) point 5.7 is replaced by the following:  
‘5.7. Germ cell mutagenicity’;  
(d) points 5.9.1 and 5.9.2 are deleted.  
Article 2  
This Regulation shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
It shall apply from 5 May 2011.  However, for registrations submitted prior to 5 May 2011, the 
chemical safety report shall be updated in accordance with this 
Regulation by 30 November 2012 at the latest. Article 22(5) of 
Regulation (EC) No 1907/2006 shall not apply to those 
updates.  
This Article is without prejudice to Articles 2 and 3 of 
Commission Regulation (EU) No 253/2011 (  1 ), with regard to 
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 BARROSOEN L 69/6 Official Journal of the European Union 16.3.2011  
( 1 ) See page 7 of this Official Journal.