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16.3.2011 Official
Journal
of
the
European
Union
L
69/7
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,
account in the review of Annex XIII with a view to
ensuring a high level of protection for human health
and the environment.
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
review
carried
out
by
the
Commission
pursuant
to
Article 138(5) of Regulation No 1907/2006 has revealed
Having regard to Regulation (EC) No 1907/2006 of
that there is a need to amend Annex XIII to that Regu
18 December 2006 of the European Parliament and of the
lation.
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
(5) Experience
shows
that,
for
the
adequate
identification
of
Regulation (EC) No 1488/94 as well as Council Directive
PBT and vPvB substances, all relevant information should
76/769/EEC and Commission Directives 91/155/EEC,
be used in an integrated manner and applying a weight-
93/67/EEC, 93/105/EC and 2000/21/EC (
of-evidence approach by comparing the information to

1 ), and in particular
Article 131 thereof,
the criteria set out in Section 1 of Annex XIII.
Whereas:
(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.
(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
(7) Accordingly,
for
the
PBT
and
vPvB
assessment
of
a
substance in the framework of registration, registrants
in accordance with the procedure laid down in
should consider all the information that is contained in
Article 58. Furthermore, Regulation (EC) No
the technical dossier.
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
(8) In
cases
where
the
technical
dossier
contains,
for
one
or
have to do a PBT and vPvB assessment comprising, as a
more endpoints, only limited information as required in
first step, a comparison with the criteria in Annex XIII to
Annexes VII and VIII to Regulation (EC) No 1907/2006,
that Regulation.
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
(2) Article
138(5)
of
Regulation
No
1907/2006
requires
the
dossier should be used for screening for P, B, or T
Commission to review Annex XIII by 1 December 2008,
properties.
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.
(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
(3) Experience
at
international
level
shows
that
substances
should develop additional information or propose addi
with characteristics rendering them persistent, liable to
tional testing to conclude its PBT and vPvB assessment,
bioaccumulate and toxic, or very persistent and very
unless the registrant implements or recommends
liable to bioaccumulate, present a very high concern.
sufficient risk management measures or operational
For that reason, the Commission has taken existing
conditions. For the same reason, registrants should not
experience in the identification of these substances into
be required to develop additional information or propose
additional testing if there is no indication of the P or B
( 1 ) OJ L 396, 30.12.2006, p. 1.
properties from the screening.

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L 69/8
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Official Journal of the European Union
16.3.2011
(10) Since
substances
can
have
one
or
more
constituents
with
Article 2
PBT or vPvB properties, or can transform or degrade into
products with such properties, the identification should
1. Registrations
of
substances
under
Regulation
(EC)
No
also take account of the PBT/vPvB-properties of such
1907/2006 and updates pursuant to Article 22 of that Regu
constituents and transformation and/or degradation
lation may be submitted in accordance with the Annex to this
products.
Regulation as from 19 March 2011 and shall comply with this
Regulation from 19 March 2013.
(11) Regulation
(EC) No 1907/2006 should therefore be
amended accordingly.
2. Registrations
of
substances
under
Regulation
(EC)
No
(12) The
measures
provided
for
in
this
Regulation
are
in
1907/2006 that are not in accordance with the Annex to this
accordance with the opinion of the Committee estab
Regulation shall be updated in order to comply with this Regu
lished under Article 133 of Regulation (EC) No
lation no later than 19 March 2013. Article 22(5) of Regulation
1907/2006,
(EC) No 1907/2006 shall not apply to those updates.
HAS ADOPTED THIS REGULATION:
Article 1
Article 3
Annex XIII to Regulation (EC) No 1907/2006 is replaced by the
This Regulation shall enter into force on the third day following
text set out in the Annex to this Regulation.
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 BARROSO

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EN
16.3.2011 Official
Journal
of
the
European
Union
L
69/9
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 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.

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1.1.3. 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.

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16.3.2011 Official
Journal
of
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European
Union L
69/11
3.1.1. 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;

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(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.’

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