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, Authorisat ion and Restriction of Chemicals (REACH) 
as regards Annex XIII  
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, Authorisat ion 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 (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 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 subs tances on their own, in preparations or 
articles, where, as part of the chemical safety assessment in accordance with Annex I, registrants have to do a PB T and vPvB assessment comprising, as a first step, a 
comparison with the criteria in A nnex XIII of that Regulation.  
(2) Article 138(5) of Regulation No 1907/2006 re quires the Commission to review Annex 
XIII by 1 December 2008, in orde r to assess the adequacy of the criteria for 
identifying 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 to xic, or very persistent and very liable to 
bioaccumulate, present a very high concern. For that reason, the Commission has taken existing experience in th e identification of these subs tances into account in the 
                                                
 
1 OJ L 396, 30.12.2006, p. 1. Regulation as corrected by OJ L 136, 29.5.2007, p.3..  
EN 3   EN review of Annex XIII with a view to ensu ring 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 of that 
Regulation.  
(5) Experience shows that, for the adequate id entification 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 inform ation 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 Se ction 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 shoul d consider all the informati on that is contained in the 
technical dossier.  
(8) In cases where the information in the tec hnical dossier contains , for one or more 
endpoints, only limited information as requir ed in Annexes VII a nd VIII of 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 indicates a 
possible P, B, or T property , or a vP or vB property, the registrant should develop 
additional information to conclude its PBT and vPvB assessment, unless the registrant 
implements or recommends sufficient ri sk management measures or operational 
conditions. For the same reason, registrant s should not be required to develop 
additional information if there is no indi cation of the P or B properties from the 
screening.  
(10) Since substances can have one or more constituents with PBT or vPvB properties, or 
can transform or degrade into  products with such propertie s, the identif ication should 
also take account of the PBT/vPvB-propert ies 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 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 XIII to Regulation (EC) No 1907/2006 is re placed by the Annex to this Regulation.   
EN 4   EN Article 2 
1. Registrations of substances under Regul ation (EC) No 1907/2006 that are not in 
accordance with the Annex to this Regulation shal l be updated in order to comply with this 
Regulation no later than [2 years after date of entry into for ce]. Article 22(5) of Regulation 
(EC) No 1907/2006 shall not apply to those updates.  
2. Registrations pursuant to Articles 6, 7, 11, 17, 18 or 19 of Regulation (EC) No 
1907/2006 and updates pursuant to Article 22 of that Regulation may be submitted in accordance with the Annex to this Regulation as from the date referred to in Article 3(1). 
Article 3 
1. This Regulation shall enter into force on the third day fo llowing that of its publication 
in the Official Journal of the European Union .  
2. It shall apply from [2 years afte r the date of entry into force].  
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President   
EN 5   EN ANNEX  
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 id entification of persistent, bioaccumulative and 
toxic substances (PBT substances ), and very persistent and ve ry bioaccumula tive substances 
(vPvB substances) as well as the information that must be considered for the purpose of 
assessing the P, B, and T pr operties 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. Where the 
criteria set out in section 1 cannot be app lied directly to the available information,  a weight-
of-evidence determination using expert  judgement shall also be applied. 
A weight-of-evidence determination means that all available information bearing on the 
identification of a PBT or a vPvB  substance is considered toge ther, such as the results of 
monitoring and modelling, suitable in vitro tests, relevant anim al 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 re ports and observations. The quality and 
consistency of the data shall be given appropria te weight. Both positive and negative results 
shall be assembled together in a sing le weight-of-evidence determination. 
The information used for the purposes of a ssessment of the PBT/vPvB properties shall be 
based on data collected under relevant conditions.  
The identification shall also take  account of the PBT/vPvB-properties of relevant constituents 
of a substance and any transformati on and/or degradation products.  
This Annex shall apply to all organi c 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 cons idered 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 es tuarine water is higher than 40 days;  
(c) the degradation half-life in marine sediment is higher than 180 days;   
EN 6   EN (d) the degradation half-life in fresh or es tuarine water sediment is higher than 
120 days;  
(e) the degradation half-life in so il is higher than 120 days. 
1.1.2. Bioaccumulation  
 A substance fulfils the bioaccumulation criterion (B) when the bioconcentration 
factor is higher than 2 000. 
1.1.3. Toxicity  A substance fulfils the toxicity criterion (T) in any of the following situations: 
(a) the long-term no-observed effect concentr ation (NOEC) or EC10 for marine or 
freshwater organisms is less than 0,01 mg/l;  
(b) the substance meets the criteria for cla ssification as carcinogenic (category 1A 
or 1B), mutagenic (category 1A or 1B),  or toxic for reproduction (category 1A, 
1B, or 2);  
(c) there is other evidence of chronic t oxicity, as identified by the substance 
meeting the criteria for classification: STOT RE cat 1 or 2 according to Regulation EC No 1272/2008. 
1.2. vPvB Substances 
 A substance that fulfils the persistence an d 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, fr esh or estuarine water is higher than 
60 days;  
(b) the degradation half-life in marine, fres h or estuarine water sediment is higher 
than 180 days;  
(c) the degradation half-life in so il is higher than 180 days. 
1.2.2. Bioaccumulation  
 A substance fulfils the "very bio accumulative" criterion (vB) when the 
bioconcentration factor is higher than 5 000. 
2. INFORMATION RELEVANT FOR THE ASSESSMENT OF P, B, and T 
PROPERTIES 
2.1 Assessment of P, B, and T propertie s in the context of Registration  
EN 7   EN For the identification of PBT a nd vPvB substances in the regi stration dossier, the registrant 
shall consider the information which is submitted as part of the technical dossier, as described in Annex I and in Sect ion 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 consid er information relevant for screening for P, 
B, or T properties in accordance with Sect ion 3.1. of this Annex. If the result from the 
screening tests or information indicate that th e substance may have PBT or vPvB properties, 
the registrant shall generate re levant additional information as set out in Section 3.2. of this 
Annex, unless the registrant impl ements or recommends sufficient risk management measures 
and operational conditions that enable derogati on according to Section 3 of Annex XI. No 
additional information needs to be generated if  there is no indication of P or B properties 
following the result from the sc reening test or information. 
2.2. Assessment of P, B, and T propertie s in the context of Authorisation 
For dossiers for the purposes of identifying substa nces 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. SCREENING AND OTHER INFORMATION 
3.1 Screening Information 
The following information shall be considered fo r screening for P, B, and T properties in the 
cases referred to in the sec ond paragraph of section 2.1 and ma y be considered for screening 
for P, B, and T properties in the context of section 2.2: 
3.1.1 Persistence  Any of the following information: 
(a) Results from tests on ready biodegrad ation in accordance with Section 9.2.1.1 
of Annex VII; 
(b) Results obtained from biodegradation (Q )SAR models in accordance with 
Section 1.3 of Annex XI;  
(c) Other information provided that its suitabi lity and reliability can be reasonably 
demonstrated. 
3.1.2 Bioaccumulation  Any of the following information: 
(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 Annex XI.1.3;  
(b) Other information provided that its suitabi lity and reliability can be reasonably 
demonstrated.  
EN 8   EN 3.1.3 Toxicity 
 Any of the following information: 
(a) Short-term aquatic toxicity in accordan ce with Section 9.1 of Annex VII and 
Section 9.1.3 of Annex VIII;  
(b) Other information provided that its suitabi lity and reliability can be reasonably 
demonstrated. 
3.2 Information for the assessment of P, B, and T properties  
3.2.1. Indication of P or vP properties:  
The definitive assessment of the P or vP prope rties shall be done on the basis of any of the 
following relevant information: 
(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 informati on from field studies or monitoring 
studies, provided that its  suitability and reliabi lity can be reasonably 
demonstrated. 
3.2.2. Indication of B or vB properties:  
The definitive assessment of the B or vB prope rties shall be done on the basis of any of the 
following relevant information: 
(a) Results from a bioaccumulation study in aquatic species;  
(b) Other information on the bioaccumulation pot ential 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 t oxicity study on animals; 
– Assessment of the toxicokinetic behaviour of the substance;   
EN 9   EN (c) Information on the ability of the substa nce to biomagnify in the food chain, 
where possible expressed by biomagnificat ion factors or tr ophic magnification 
factors. 
3.2.3. Indication of T properties:  
The definitive assessment of the T properties shall be done on the basis of any of the 
following relevant information: 
(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; 
(c) Results from growth inhibition study on a quatic 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 (possible assigned hazard phrases: H350 and H350i), germ cell mutagenic in Category 1A or 1B (assigned hazard phrase: H340), specific target organ toxic after repeated dose  in Category 1 or 2 (assigned hazard 
phrase: H372 or H373), toxic to repr oduction in Category 1A, 1B and/or 2 
(possible assigned hazard phrases : H360F, H360D, H360FD, H360Fd, 
H360fD, H361f, H361da and H361fd); 
(e) Results from long term or reproductive toxi city testing with bi rds as set out in 
Section 9.6.1 of Annex X;  
(f) Other information provided that its suitabi lity and reliability can be reasonably 
demonstrated.