GUIDANCE

Guidance on the preparation of an Annex

XV dossier for the identification of
substances of very high concern

Version 2.0
February 2014
 Guidance on the preparation of an Annex XV dossier for the identification of
substances of very high concern
2 Version 2.0 February 2014

LEGAL NOTE

This document contains guidance on REACH explaining the REACH obligations and how to fulfil
them. However, users are reminded that the text of the REACH Regulation is the only
authentic legal reference and that the information in this document does not constitute legal
advice. The European Chemicals Agency does not accept any liability with regard to the
contents of this document.

Guidance on the preparation of an Annex XV dossier for the identification of

substances of very high concern

Reference: ECHA-14-G-01-EN
ISBN: 978-92-9244-236-1
Publ.date: February 2014
Language: EN
© European Chemicals Agency, 2014

Cover page © European Chemicals Agency

Reproduction is authorised provided the source is fully acknowledged in the form

“Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written
notification is given to the ECHA Communication Unit ([email protected]).

If you have questions or comments in relation to this document please send them (indicating
the document reference, issue date, chapter and/or page of the document to which your
comment refers) using the Guidance feedback form. The feedback form can be accessed via
the ECHA Guidance website or directly via the following link:
https://comments.echa.europa.eu/comments_cms/FeedbackGuidance.aspx

European Chemicals Agency

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland

Visiting address: Annankatu 18, Helsinki, Finland
Guidance on the preparation of an Annex XV dossier for the identification of
substances of very high concern
Version 2.0 February 2014 3

Preface
This Guidance Document describes how the authorities (Member States Competent Authorities
or the European Chemicals Agency) can prepare a dossier in accordance with Annex XV to
identify a substance of very high concern under REACH. It is part of a series of guidance
documents that aim to help all stakeholders with their preparation for fulfilling their obligations
under the REACH Regulation. These documents cover detailed guidance for a range of essential
REACH processes as well as for some specific scientific and/or technical methods that industry
or authorities need to make use of under REACH.

These guidance documents can be obtained via the website of the European Chemicals Agency
(http://echa.europa.eu/guidance-documents/guidance-on-reach).

The legal references for the document are 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 (the REACH Regulation) 1 and 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 2.

1
Corrigendum 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 (OJ L 396, 30.12.2006).
2
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 (OJ L 353, 31.12.2008, p.1).
 Guidance on the preparation of an Annex XV dossier for the identification of
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Document History

Version Changes Date

Version 1.0 First edition (original unnumbered version). June 2007

Version 2.0 Second edition. The second edition of this document involved a February 2014
complete overhaul of the text resulting in a reduction in the amount
of detailed guidance given within this document itself. Instead,
references are now given within the document to where specific
instructions on how to prepare an Annex XV SVHC dossier can be
found, including where to access the template for use in generating
the Annex XV SVHC report.
The revision was necessary in order to take into account actual
experience gained by the Member State Competent Authorities and
ECHA in the preparation of dossiers and real working practices and to
take account of the amendment of Annex XIII of REACH (according
to Commission Regulation (EU) No 253/2011 of 15 March 2011, OJ L
69 7 16.3.2011). Most of the content of the previous version of the
guidance had been written before REACH came into force and
therefore before real experience was available on implementing the
processes it described.
In addition, the title of the document has been amended slightly to
“Guidance on the preparation of an Annex XV dossier for the
identification of substances of very high concern” to better align it
with the text of Annex XV itself.
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Table of Contents

1. INTRODUCTION .................................................................................................... 6
2. LEGAL FRAMEWORK.............................................................................................. 6
3. PREPARATION OF AN ANNEX XV DOSSIER FOR THE IDENTIFICATION OF
SUBSTANCES OF VERY HIGH CONCERN (ARTICLE 57 OF REACH)........................ 7
3.1 Before starting to prepare a dossier ........................................................................ 7
3.2 Preparing a dossier ............................................................................................... 7
3.3 Further guidance and support ................................................................................ 8
3.4 What to do when an Annex XV dossier is not appropriate .......................................... 9
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1. Introduction
This document provides technical guidance to the Member States and the European Chemicals
Agency on the preparation of a dossier in accordance with Annex XV to REACH. It gives
guidance on how to propose and justify the identification of substances of very high concern
(‘SVHCs’) in accordance with the procedure set out in Article 59 of the REACH Regulation
(hereinafter referred to as an ‘Annex XV SVHC dossier’). In this document the term ‘Authority’
is used to refer to the Agency (i.e. ECHA) or any Member State competent authority
developing an Annex XV SVHC dossier. Where the term SVHC is used in this guidance, it refers
to all substances covered by Article 57 of REACH.

2. Legal framework
The authorisation procedure aims to ensure that the risks from SVHCs are properly controlled
and that these substances are progressively replaced by suitable alternatives where these are
economically and technically viable, whilst at the same time ensuring the good functioning of
the EU internal market. A description of the procedure to include substances in the
authorisation process is available in the Regulations section of ECHA’s website at:
http://echa.europa.eu/web/guest/regulations/reach/authorisation.

SVHCs which may be included in Annex XIV to REACH, and for which thereby the authorisation
requirement will be established, are substances with the following properties:

Legal reference Hazard class Identification criteria

Article 57 (a) Carcinogenicity category 1 Section 3.6 of Annex I to the Regulation (EC) No
REACH A/B 1272/2008 (CLP Regulation)

Article 57 (b) Germ cell mutagenicity Section 3.5 of Annex I to the CLP Regulation
REACH category 1 A/B

Article 57 (c) Reproductive toxicity Section 3.7 of Annex I to the CLP Regulation
REACH category 1 A/B, adverse
effects on sexual function
and fertility or on
development
3
Article 57 (d) Persistent, bioaccumulative Annex XIII to the REACH Regulation (as amended )
REACH and toxic (PBT)
3
Article 57 (e) Very persistent and very Annex XIII to the REACH Regulation (as amended )
REACH bioaccumulative (vPvB)

Article 57 (f) Equivalent level of concern Substances - such as those having endocrine
REACH to those of other disrupting properties or those having persistent,
substances listed in point bioaccumulative and toxic properties or very
(a) to (e) of Article 57 of persistent and very bioaccumulative properties, which
4
REACH do not fulfil the criteria of Article 57 points (d) or (e) -
for which there is scientific evidence of probable
serious effects to human health or the environment
which give rise to an equivalent level of concern to
those of other substances listed in Article 57 points
(a) to (e) and which are identified on a case-by-case
basis in accordance with the procedure set out in
Article 59 of REACH.

3
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 (OJ L 69/7, 16.3.2011)
4
Hereinafter referred to as ‘substances of equivalent level of concern’
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3. Preparation of an Annex XV dossier for the identification

of substances of very high concern (Article 57 of REACH)
3.1 Before starting to prepare a dossier

Before initiating work on an Annex XV SVHC dossier, the Authority should check whether
another Member State or the Agency is already preparing such a dossier on the same
substance or whether the substance is currently subject to another process under REACH (e.g.
restriction, substance evaluation etc.). This can be done by checking the Registry of Intentions
(RoI) 5. Furthermore, it should be checked whether the substance is listed in the Community
Rolling Action Plan (CoRAP) for substance evaluation.

Even if the substance is not listed in any of the formal REACH or CLP processes, the Authority
is encouraged to check via the Activities Coordination Tool (ACT) whether the substance is
under consideration by other Member States for further regulatory risk management (RRM). If
another process is under consideration or has been initiated for the same substance, it is
recommended to contact the other Authorities working on the substance to ensure that work is
not duplicated.

Where the SVHC identification is based on an adverse effect for which classification criteria
have been defined in the CLP Regulation and the substance has not yet been classified for such
adverse effect, it is strongly recommended to first use the process set out in the CLP
Regulation to conclude whether these criteria are met before proposing such substance to be
identified for inclusion in the candidate list. Where the identification is not based on effects for
which there are classification criteria in the CLP Regulation, more information and advice on
how to assess and structure the relevant information can be found within this guidance and in
related documents on the support section of ECHA’s web-site:
http://echa.europa.eu/web/guest/support/authorisation/substances-of-very-high-concern-
identification.

3.2 Preparing a dossier

As soon as the Authority starts work on preparing the Annex XV dossier, they should inform
ECHA, so that the ACT entry for the substance can be updated promptly and the information
on the intention to prepare an Annex XV SVHC dossier can be included in the RoI.

An Annex XV SVHC dossier consists of two parts:

a) The Annex XV SVHC report: This report should be attached to the technical dossier in
IUCLID.

The information provided in Part I of the report is used to make the hazard based
assessment of the properties and to confirm whether the substance can be successfully
identified as an SVHC.

The information in Part II of the report is used in the next step of the authorisation
process, i.e. the prioritisation of substances from the Candidate List to be recommended
for inclusion in Annex XIV to REACH (and become subject to the authorisation
requirements). The registration dossiers are the main source of information for this

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part of the SVHC report. In addition, information from downstream user reports and
classification and labelling notifications should be used. Furthermore, any other available
relevant information can be used.

b) A technical dossier (in IUCLID format): This should include information on substance
composition and can include robust study summaries imported from registration dossiers.
It is recommended to copy these robust study summaries, stored as endpoint study
records in IUCLID, as references (cf. referencing endpoint study records in the IUCLID
manual D.4.7.10). In that way, the link with the source of the information used in the
Annex XV SVHC report remains available. These reference study records can be annotated
by the Authority as needed, or new (robust) study summaries can be created by the
Authority when the information extracted from the registration dossiers is incorrect or
should be revised substantially or when additional data is available.

The expression “Annex XV SVHC dossier” is used in this Guidance to refer to the combined
package of a) the Annex XV SVHC report, plus, b) the technical (IUCLID) dossier.

The Authority should (i) collect the relevant information, (ii) assess the information, (iii)
compare it to the relevant criteria, (iv) draw conclusions as to whether the criteria are met and
(v) document the information, assessment and conclusions in the Annex XV SVHC report.

The Guidance on Information Requirements and Chemical Safety Assessment (IR&CSA)

(available at http://echa.europa.eu/web/guest/guidance-documents/guidance-on-information-
requirements-and-chemical-safety-assessment) contains detailed guidance on the
interpretation of studies in relation to the individual criteria. The present guidance therefore
does not discuss technical issues in relation to such studies. If the basis for the identification is
Article 57 of REACH (a), (b) or (c), (i.e. it is Carcinogenic/Mutagenic/Toxic for Reproduction
category 1A/B (CMR)), then it is sufficient to provide in Part I of the Annex XV SVHC report a
reference to the respective entry in Annex VI of the CLP Regulation. If the basis for the
identification is Article 57 (d), (e) or (f), then the Annex XV SVHC dossier should provide full
details on how these criteria have been met.

Authorities should use the annotated Annex XV template when preparing an Annex XV
report, proposing the identification of a substance as an SVHC. It is available on the support
section of ECHA’s web-site at:
http://echa.europa.eu/web/guest/support/authorisation/substances-of-very-high-concern-
identification.

3.3 Further guidance and support

More detailed information and advice can be found in the support section of the ECHA website
under “substances of very high concern identification”:
http://echa.europa.eu/web/guest/support/authorisation/substances-of-very-high-concern-
identification, including the annotated Annex XV template for the preparation of the Annex XV
report.

Procedural advice including ECHA’s procedure for handling the identification of SVHCs is also
provided in the aforementioned section, with the aim of ensuring that it is the latest available
information on emerging and developing issues, with respect to SVHCs.

The support section also contains guidance documents on the identification and naming of
substances under REACH and CLP and on IR&CSA. Part C and Chapter R.11 of the Guidance on
IR&CSA are particularly relevant for PBT/vPvB assessment, as these parts/chapters describe
the scientific methods associated with the assessment. See: http://echa.europa.eu/guidance-
documents/guidance-on-reach.
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3.4 What to do when an Annex XV dossier is not appropriate

There may be cases where the Authority carries out work on an Annex XV dossier but
concludes that there is no need for a dossier at this point in time. In such cases, it is important
that the work that has already been undertaken is not lost, but is made available for potential
future work. Thus, the Authority is encouraged to record the results of the work it has carried
out via the ACT. A simple description of the work undertaken and the reasons why it was
decided not to proceed may be sufficient.
EUROPEAN CHEMICALS AGENCY
ANNANKATU 18, P.O. BOX 400,
FI-00121 HELSINKI, FINLAND
ECHA.EUROPA.EU