COMMISSION REGULATION (EU) No 253/2011  
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 
XIII  
(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 
18 December 2006 of the European Parliament and of the 
Council 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 1907/2006 provides that substances 
which are persistent, bioaccumulative and toxic (PBT) as 
well as substances which are very persistent and very 
bioaccumulative (vPvB) in accordance with the criteria 
set out in Annex XIII may be included in Annex XIV 
in accordance with the procedure laid down in 
Article 58. Furthermore, Regulation (EC) No 
1907/2006 establishes registration obligations of Union 
manufacturers or importers of substances on their own, 
in mixtures or articles, where, as part of the chemical 
safety assessment in accordance with Annex I, registrants 
have to do a PBT and vPvB assessment comprising, as a 
first step, a comparison with the criteria in Annex XIII to 
that Regulation.  
(2) Article 138(5) of Regulation No 1907/2006 requires the 
Commission to review Annex XIII by 1 December 2008, 
in order to assess the adequacy of the criteria for iden ­
tifying substances which are PBT or vPvB, with a view to 
proposing an amendment to it, if appropriate.  
(3) Experience at international level shows that substances 
with characteristics rendering them persistent, liable to 
bioaccumulate and toxic, or very persistent and very 
liable to bioaccumulate, present a very high concern. 
For that reason, the Commission has taken existing 
experience in the identification of these substances into account in the review of Annex XIII with a view to 
ensuring a high level of protection for human health 
and the environment.  
(4) The review carried out by the Commission pursuant to 
Article 138(5) of Regulation No 1907/2006 has revealed 
that there is a need to amend Annex XIII to that Regu ­
lation.  
(5) Experience shows that, for the adequate identification of 
PBT and vPvB substances, all relevant information should 
be used in an integrated manner and applying a weight- 
of-evidence approach by comparing the information to 
the criteria set out in Section 1 of Annex XIII.  
(6) A weight-of-evidence determination is particularly 
relevant in cases where the application of the criteria 
set out in Section 1 of Annex XIII to the available 
information is not straightforward.  
(7) Accordingly, for the PBT and vPvB assessment of a 
substance in the framework of registration, registrants 
should consider all the information that is contained in 
the technical dossier.  
(8) In cases where the technical dossier contains, for one or 
more endpoints, only limited information as required in 
Annexes VII and VIII to Regulation (EC) No 1907/2006, 
the available data may not allow to reach a definitive 
conclusion on the PBT or vPvB properties. In such 
cases, the relevant information available in the technical 
dossier should be used for screening for P, B, or T 
properties.  
(9) In order to avoid unnecessary studies, only in cases 
where the screening assessment indicates a possible P, 
B, or T property, or a vP or vB property, the registrant 
should develop additional information or propose addi ­
tional testing to conclude its PBT and vPvB assessment, 
unless the registrant implements or recommends 
sufficient risk management measures or operational 
conditions. For the same reason, registrants should not 
be required to develop additional information or propose 
additional testing if there is no indication of the P or B 
properties from the screening.EN 16.3.2011 Official Journal of the European Union L 69/7  
( 1 ) OJ L 396, 30.12.2006, p. 1.(10) Since substances can have one or more constituents with 
PBT or vPvB properties, or can transform or degrade into 
products with such properties, the identification should 
also take account of the PBT/vPvB-properties of such 
constituents and transformation and/or degradation 
products.  
(11) Regulation (EC) No 1907/2006 should therefore be 
amended accordingly.  
(12) The measures provided for in this Regulation are in 
accordance with the opinion of the Committee estab ­
lished under Article 133 of Regulation (EC) No 
1907/2006,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XIII to Regulation (EC) No 1907/2006 is replaced by the 
text set out in the Annex to this Regulation.  Article 2  
1. Registrations of substances under Regulation (EC) No 
1907/2006 and updates pursuant to Article 22 of that Regu ­
lation may be submitted in accordance with the Annex to this 
Regulation as from 19 March 2011 and shall comply with this 
Regulation from 19 March 2013.  
2. Registrations of substances under Regulation (EC) No 
1907/2006 that are not in accordance with the Annex to this 
Regulation shall be updated in order to comply with this Regu ­
lation no later than 19 March 2013. Article 22(5) of Regulation 
(EC) No 1907/2006 shall not apply to those updates.  
Article 3  
This Regulation shall enter into force on the third day following 
its publication in the  Official Journal of the European Union . 
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 69/8 Official Journal of the European Union 16.3.2011ANNEX  
‘ANNEX XIII  
CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, 
AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES  
This Annex lays down the criteria for the identification of persistent, bioaccumulative and toxic substances (PBT 
substances), and very persistent and very bioaccumulative substances (vPvB substances) as well as the information that 
must be considered for the purpose of assessing the P, B, and T properties of a substance.  
For the identification of PBT substances and vPvB substances a weight-of-evidence determination using expert judgement 
shall be applied, by comparing all relevant and available information listed in Section 3.2 with the criteria set out in 
Section 1. This shall be applied in particular where the criteria set out in Section 1 cannot be applied directly to the 
available information.  
A weight-of-evidence determination means that all available information bearing on the identification of a PBT or a vPvB 
substance is considered together, such as the results of monitoring and modelling, suitable in vitro tests, relevant animal 
data, information from the application of the category approach (grouping, read-across), (Q)SAR results, human 
experience such as occupational data and data from accident databases, epidemiological and clinical studies and well 
documented case reports and observations. The quality and consistency of the data shall be given appropriate weight. The 
available results regardless of their individual conclusions shall be assembled together in a single weight-of-evidence 
determination.  
The information used for the purposes of assessment of the PBT/vPvB properties shall be based on data obtained under 
relevant conditions.  
The identification shall also take account of the PBT/vPvB-properties of relevant constituents of a substance and relevant 
transformation and/or degradation products.  
This Annex shall apply to all organic substances, including organo-metals.  
1. CRITERIA FOR THE IDENTIFICATION OF PBT AND vPvB SUBSTANCES  
1.1. PBT Substances  
A substance that fulfils the persistence, bioaccumulation and toxicity criteria of Sections 1.1.1, 1.1.2 and 1.1.3 
shall be considered to be a PBT substance.  
1.1.1. Persistence  
A substance fulfils the persistence criterion (P) in any of the following situations:  
(a) the degradation half-life in marine water is higher than 60 days;  
(b) the degradation half-life in fresh or estuarine water is higher than 40 days;  
(c) the degradation half-life in marine sediment is higher than 180 days;  
(d) the degradation half-life in fresh or estuarine water sediment is higher than 120 days;  
(e) the degradation half-life in soil is higher than 120 days.  
1.1.2. Bioaccumulation  
A substance fulfils the bioaccumulation criterion (B) when the bioconcentration factor in aquatic species is higher 
than 2 000.EN 16.3.2011 Official Journal of the European Union L 69/91.1.3. Toxicity  
A substance fulfils the toxicity criterion (T) in any of the following situations:  
(a) the long-term no-observed effect concentration (NOEC) or EC10 for marine or freshwater organisms is less 
than 0,01 mg/l;  
(b) the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic 
(category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Regulation EC 
No 1272/2008;  
(c) there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: 
specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC 
No 1272/2008.  
1.2. vPvB Substances  
A substance that fulfils the persistence and bioacumulation criteria of Sections 1.2.1 and 1.2.2 shall be considered 
to be a vPvB substance.  
1.2.1. Persistence  
A substance fulfils the “very persistent” criterion (vP) in any of the following situations:  
(a) the degradation half-life in marine, fresh or estuarine water is higher than 60 days;  
(b) the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days;  
(c) the degradation half-life in soil is higher than 180 days.  
1.2.2. Bioaccumulation  
A substance fulfils the “very bioaccumulative” criterion (vB) when the bioconcentration factor in aquatic species is 
higher than 5 000.  
2. SCREENING AND ASSESSMENT OF P, vP, B, vB and T PROPERTIES  
2.1. Registration  
For the identification of PBT and vPvB substances in the registration dossier, the registrant shall consider the 
information as described in Annex I and in Section 3 of this Annex.  
If the technical dossier contains for one or more endpoints only information as required in Annexes VII and VIII, 
the registrant shall consider information relevant for screening for P, B, or T properties in accordance with Section 
3.1 of this Annex. If the result from the screening tests or other information indicate that the substance may have 
PBT or vPvB properties, the registrant shall generate relevant additional information as set out in Section 3.2 of 
this Annex. In case the generation of relevant additional information would require information listed in Annexes 
IX or X, the registrant shall submit a testing proposal. Where the process and use conditions of the substance meet 
the conditions as specified in Section 3.2(b) or (c) of Annex XI the additional information may be omitted, and 
subsequently the substance is considered as if it is a PBT or vPvB in the registration dossier. No additional 
information needs to be generated for the assessment of PBT/vPvB properties if there is no indication of P or 
B properties following the result from the screening test or other information.  
2.2. Authorisation  
For dossiers for the purposes of identifying substances referred to in Article 57(d) and Article 57(e), relevant 
information from the registration dossiers and other available information as described in Section 3 shall be 
considered.  
3. INFORMATION RELEVANT FOR THE SCREENING AND ASSESSMENT OF P, vP, B, vB and T PROPERTIES  
3.1. Screening Information  
The following information shall be considered for screening for P, vP, B, vB and T properties in the cases referred 
to in the second paragraph of Section 2.1 and may be considered for screening for P, vP, B, vB and T properties in 
the context of Section 2.2.EN L 69/10 Official Journal of the European Union 16.3.20113.1.1. Indication of P and vP properties  
(a) Results from tests on ready biodegradation in accordance with Section 9.2.1.1 of Annex VII;  
(b) Results from other screening tests (e.g. enhanced ready test, tests on inherent biodegradability);  
(c) Results obtained from biodegradation (Q)SAR models in accordance with Section 1.3 of Annex XI;  
(d) Other information provided that its suitability and reliability can be reasonably demonstrated.  
3.1.2. Indication of B and vB properties  
(a) Octanol-water partitioning coefficient experimentally determined in accordance with Section 7.8 of Annex VII 
or estimated by (Q)SAR models in accordance with Section 1.3 of Annex XI;  
(b) Other information provided that its suitability and reliability can be reasonably demonstrated.  
3.1.3. Indication of T properties  
(a) Short-term aquatic toxicity in accordance with Section 9.1 of Annex VII and Section 9.1.3 of Annex VIII;  
(b) Other information provided that its suitability and reliability can be reasonably demonstrated.  
3.2. Assessment Information  
The following information shall be considered for the assessment of P, vP, B, vB and T properties, using a 
weight-of-evidence approach.  
3.2.1. Assessment of P or vP properties  
(a) Results from simulation testing on degradation in surface water;  
(b) Results from simulation testing on degradation in soil;  
(c) Results from simulation testing on degradation in sediment;  
(d) Other information, such as information from field studies or monitoring studies, provided that its suitability 
and reliability can be reasonably demonstrated.  
3.2.2. Assessment of B or vB properties  
(a) Results from a bioconcentration or bioaccumulation study in aquatic species;  
(b) Other information on the bioaccumulation potential provided that its suitability and reliability can be 
reasonably demonstrated, such as:  
— Results from a bioaccumulation study in terrestrial species;  
— Data from scientific analysis of human body fluids or tissues, such as blood, milk, or fat;  
— Detection of elevated levels in biota, in particular in endangered species or in vulnerable populations, 
compared to levels in their surrounding environment;  
— Results from a chronic toxicity study on animals;  
— Assessment of the toxicokinetic behaviour of the substance;  
(c) Information on the ability of the substance to biomagnify in the food chain, where possible expressed by 
biomagnification factors or trophic magnification factors.  
3.2.3. Assessment of T properties  
(a) Results from long-term toxicity testing on invertebrates as set out in Section 9.1.5 of Annex IX;  
(b) Results from long-term toxicity testing on fish as set out in Section 9.1.6 of Annex IX;EN 16.3.2011 Official Journal of the European Union L 69/11(c) Results from growth inhibition study on aquatic plants as set out in in Section 9.1.2 of Annex VII;  
(d) The substance meeting the criteria for classification as carcinogenic in Category 1A or 1B (assigned hazard 
phrases: H350 or H350i), germ cell mutagenic in Category 1A or 1B (assigned hazard phrase: H340), toxic for 
reproduction in Category 1A, 1B and/or 2 (assigned hazard phrases: H360, H360F, H360D, H360FD, H360Fd, 
H360fD, H361, H361f, H361d or H361fd), specific target organ toxic after repeated dose in Category 1 or 2 
(assigned hazard phrase: H372 or H373), according to Regulation EC No 1272/2008;  
(e) Results from long-term or reproductive toxicity testing with birds as set out in Section 9.6.1 of Annex X;  
(f) Other information provided that its suitability and reliability can be reasonably demonstrated.’EN L 69/12 Official Journal of the European Union 16.3.2011