EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(20..) yyy final 
Draft 
COMMISSION REGULATION (EU) No …/.. 
of  
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   
EN 2   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of 
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 Regi stration, Evaluation, Authorisation and 
Restriction of Chemicals (REA CH), 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 1907/20062 harmonises the provisions and criteria for the 
classification and labelling of substances, mi xtures and certain specific articles within 
the Community, taking into accoun t the classification criteria and labelling rules of the 
Globally Harmonised System of Classifi cation and Labelling of Chemicals. 
(2) Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, 
regulations and administrative provisions re lating to the classification, packaging and 
labelling of dangerous substances3 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 administ rative provisions of the Memb er States relating to the 
classification, packaging and labe lling of dangerous preparations4 were amended 
                                                 
1 OJ L 396, 30.12.2006, p. 1. Regulation as corrected by OJ L 136, 29.5.2007, p.3. 
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.  
EN 3   EN several times. Directives 67/548/EEC and 1999/45/EC will be replaced over a 
transitional period according to which substa nces must be classified, labelled and 
packaged according to Regulation (E C) 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 Directiv es 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 s hould 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 classi fication criteria in Regulation (EC) No 
1272/2008. This also has clear consequences  for Annex I to Regulation (EC) No 
1907/2006, which was not amended by Regulati on (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 s ubstantive changes in terminology and 
concepts compared to those used in Directive 67/548/EEC. A nnex I to Regulation 
(EC) No 1907/2006 was not amended by Re gulation (EC) No 1272/2008 and should 
be updated to reflect these changes. 
(6) Furthermore, references to  Directive 67/548/EEC should be  replaced by appropriate 
references to Regulation (EC) No 1272/2008. 
(7) In accordance with Regulation (EC) No 1907/2006, registrations including chemical 
safety reports will have been submitted by th e date of application of this Regulation. 
Changes in classification criteria and ot her relevant provisi ons resulting from 
Regulation (EC) No 1272/2008 apply to su bstances from 1 December 2010, in 
accordance with the second para graph 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 Regulati on are in accordance with the opinion of the 
Committee established under 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  
EN 4   EN 0.6.1. A chemical safety assessment perfor med by a manufacturer or an importer for 
a substance shall include the following st eps 1 to 4 in accordance with the 
respective sections of this Annex: 
1. Human health hazard assessment. 2. Human health hazard assessmen t of physicochemical properties. 
3. Environmental hazard assessment. 4. PBT and vPvB assessment. 
0.6.2. In the cases referred to in points 0.6.3 and 0.6.4, the chemical safety 
assessment shall also include the follo wing steps 5 and 6 in  accordance with  
Sections 5 and 6 of this Annex: 
 5. Exposure assessment 
5.1. The generation of exposure scen ario(s) (or the identification of 
relevant use and exposure cat egories 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 Regu lation (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 Sect ions 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 categorie s 1 and 2, 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 Where as a result of steps 1 to 4 th e manufacturer or importer concludes that 
the mixture meets the criteria for cl assification as dangerous according to 
Directive 1999/45/EC 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. 
0.6.5. A summary of all the relevant inform ation used in addressing the points 
above, shall be presented under the releva nt heading of the Chemical Safety 
Report (Section 7).”;  
EN 5   EN (2) point 1.0.1 is replaced by the following: 
 “1.0.1. The objectives of the human heal th hazard assessment shall be to 
determine the classification and labelling 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 assessm ent shall consider the toxicokinetic 
profile (i.e. absorption, metabolism, distri bution and elimination) of the substance 
and the following groups of effects: 
 (1) acute effects such as acute t oxicity, irritation and corrosivity,  
 (2) sensitisation,   (3) repeated dose toxicity and   (4) CMR effects (carcinogenity, germ cell mutagenicity 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 
administration) and other relevant informa tion shall be presented, in internationally 
recognised units of measurement for that effect." 
(5) points 1.3.1 and 1.3.2 are replaced by the following:  “1.3.1. The appropriate classification a nd labelling 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 
Title II 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 stat ement as to whether the substance fulfils 
or does not fulfil the criteria given in Regulation (EC) No 1272/2008 for CMR, 
categories 1A and 1B. 
 1.3.2.  If the information is  inadequate to decide wh ether 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.”;  
EN 6   EN (6) the second sentence of point 1.4.1 is replaced by the following: 
 “For some hazard classes, especially germ cell mutageni city and carcinogenicity, the 
available information may not enable a threshold, and therefore a DNEL, to be 
established.” 
(7) point 2.1 is replaced by the following: 
“2.1 The objective of the hazard assessmen t for physicochemical properties shall be 
to determine the classification and label ling 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 are inadequate to decide  whether a substance s hould be classified 
for a particular hazard class or category, the registrant sh all indicate and justify the 
action or decision he ha s taken as a result.”; 
(9) point 2.5 is replaced by the following:  “2.5 The appropriate classification and la belling 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 environmen tal hazard assessm ent shall be to 
determine the classification and labelling of a substance in accordance with Regulation (EC) No 1272/2008 and to identi fy 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 a nd labelling 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 Title II of Regulation (EC) No 1272/2008 shall be presente d and, if it is not included in Part 3 
of Annex VI to Regulation (EC) No 1272/2008, justified.  
EN 7   EN  3.2.2.  If the information are inadequate to decide whether a substance should 
be classified for a particular hazard class or category, the registra nt shall indicate and 
justify the action or decision he has taken as a result.”; 
(l2) Part B of the table in sect ion 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;  (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 twentieth day following that of its publication in 
the Official Journal of  the European Union . 
It shall apply from [ Please fill in with a concrete date.  This will be the date falling 1 month 
after entry into force date, to be filled in by OPOCE ]. 
However, for registrations submitted prior to [ Please fill in with the date of application, this 
will be the same date as in previous paragraph ], the chemical safety report shall be updated in 
accordance with this Regulation by 30 November 2012 at the latest.  
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President