First Steps of Author Is at Ion - ECHA ALS

First steps of authorisation
Anna-Liisa Sundquist
26 May 2009
http://echa.europa.eu
Annex XV dossiers – Step 0
• Member States (MS’s) or ECHA from request of
the Commission can prepare and submit to
ECHA
– Annex XV dossier for identification of Substances of
Very High Concern (SVHC)
• Specifying the intrinsic properties for identification
of SVHC
• Providing information on uses and alternatives
• Registry of Intentions on ECHA’s website to
provide information on MS’s (or COM’s) plans
Identification of SVHC’s - Step 1
• Pay attention to the strict timeline of the identification
process – max 105 days!
• Identification of SVHC will focus on intrinsic properties of
substances as defined in Art 57
• Public consultation will be organised by ECHA on the
proposed substances based on Annex XV dossiers
– If comments are received on a substance the substance will be
addressed in the Member State Committee (MSC) which will
seek unanimous agreement on identification as a SVHC
– When unanimous agreement reached by the MSC the
substance will be included in the candidate list by ECHA (if no
unanimous agreement -> to the Commission for identification)
– Comments on uses, releases and alternatives are also
welcomed but will not be taken into account in the identification-
of-SVHC-step
Timeschedule of submission of
Annex XV dossiers for SVHC
• Annex XV dossiers will be submitted by the MS’s
twice a year
– By 3 August 2009
– By 8 February 2010
– By 2 August 2010
• Candidate list will be updated twice a year
immediately after the MSC has found the
agreement on identification of SVHC’s
• Information requirements will follow from
inclusion of the substance in the candidate list
Preparation of the recommendation
for the “authorisation list”- Step 2
• ECHA will prepare its recommendation for inclusion of
substances in Annex XIV (“authorisation list”) prioritising
substances from the candidate list
– The first recommendation shall be submitted by ECHA to the
Commission by 1 June 2009
• MSC is requested to give its opinion on ECHA’s draft
recommendation for the “authorisation list” taking into
account the comments given in the public consultation
on ECHA’s draft recommendation as well as considering
all justification documents
– Public consultation on the 1st draft recommendation took place
14 Jan – 14 Apr 2009
ECHA’s draft recommenation
• Seven substances proposed to be prioritised from the “candidate list” to the
“authorisation list” on the basis of Article 58(3) criteria:
normally
• PBT/vPvB substance or
• High volumes or
• Wide dispersive uses
• Documents in the public consultation
– The draft recommendation for Annex XIV of the REACH Regulation
– “General priority setting approach” elaborating qualitatively and semi-
quantitatively the prioritisation criteria
– Technical reports, background documents and justification for specifying the
application dates and sunset dates as well as other items for Annex XIV
• Note:
– Strict timelines of the process
– Hazards of substances should not be open for discussion (done in the previous
step)
– Only comments provided in the public consultation will be considered by ECHA
and responded to (Responses to Comments-tables)
Draft Recommendation of priority substances to be included
in Annex XIV of the REACH Regulation
Substance Intrinsic Transitional arrangements Rev Exempted (categories of) uses

property Application Sunset iew
(ies) date date peri
ods
5-tert-butyl-2,4,6-trinitro-m- vPvB [Date of [Date of - -
xylene (article inclusion in inclusion
(Musk xylene) 57(e)[1]) Annex XIV + 24 in Annex
EC number: 201-329-4 months] XIV + 42
CAS number: 81-15-2 months]
4,4’- Carcinog [Date of [Date of - Placing on the market in preparation for supply to the
Diaminodiphenylmethane enic - inclusion in inclusion general public for the use as artists’ paints which are
(MDA) category Annex XIV + 24 in Annex covered by Directive 1999/45/EC
2 months] XIV + 42
(article months]
EC number: 202-974-4
57(a)[2])
CAS number: 101-77-9

Alkanes, C10-13, chloro PBT and [Date of [Date of - Placing on the market as in preparation in concentration
(Short Chain Chlorinated vPvB inclusion in inclusion at or lower than 1 % by weight for a use in
Paraffins - SCCPs) (article Annex XIV + 27 in Annex -metalworking
EC number: 287-476-5 57(d)&(e) months] XIV + 45 -fat liquoring of leather
CAS number: 85535-84-8 1
) months]
[1]
An authorisation may be granted only in accordance with Article 60(4) (‘socio-economic route’)
[2]
According to available information it is not possible to determine a threshold in accordance with Section 6.4 of Annex I.
Therefore, an authorisation may be granted only in accordance with Article 60(4) (‘socio-economic route’)
Hexabromocyclododecane (and PBT [Date of [Date of - -
all major diastereoisomers (article inclusion inclusion in
identified, i.e. alpha-, beta- and 57(d)1) in Annex Annex XIV +
gamma- XIV + 27 45 months]
hexabromocyclododecane) months]
(HBCDD)
EC number:247-148-4
and 221-695-9
CAS number:25637-99-4
and 3194-55-6
(diastereoisomers, respectively:
134237-50-6,
134237-51-7, 134237-52-8)
Bis(2-ethylhexyl) phthalate Toxic to [Date of [Date of - Placing on the market in preparation for
(DEHP) reprodu inclusion in inclusion in supply to the general public for the use
EC number: 204-211-0 ction – Annex XIV Annex XIV + 48 as artists’ paints which are covered by
CAS number: 117-81-7 categor + 30 months] Directive 1999/45/EC
y2 months]
(article
57(c)[1])
Benzyl butyl phthalate Toxic to [Date of [Date of - Placing on the market in preparation for
(BBP) reprodu inclusion in inclusion in supply to the general public for the use
y2 months]
(article
57(c)3)
Dibutyl phthalate Toxic to [Date of [Date of - Placing on the market in preparation for
(DBP) reprodu inclusion in inclusion in supply to the general public for the use
y2 months]
(article
57(c)3)
[1]
According to available information it is possible to determine a threshold in accordance with Section 6.4 of Annex I.
Therefore, if the risk to human health from the use of the substance arising from intrinsic properties specified in Annex XIV is adequately controlled
in accordance with Section 6.4 of Annex I and as documented in the applicant's chemical safety report, an authorisation will be granted in accordance
with Article 60(2) (‘adequate control route’); if not, an authorisation may be granted in accordance with Article 60(4) (‘socio-economic route’).
Public consultation – Outcome
Some brief statistics:
• ca. 365 comments submitted on all 15
substances currently on the Candidate List
• from 25 countries (19 EU-countries + Norway;

Switzerland, Japan, US, Egypt, Turkey)
• 12 MSCAs (incl. NO) submitted comments
• the most commented substances: phthalates (33

%; 17% for DEHP only), HBCDD (17 %), MDA (7
%), musk xylene (5%) and SCCPs (5 %)
Responses to comments
• ECHA has developed responses to all comments
(RCOMs)
• Standard replies used for recurring issues
• Non-confidential version will be published on the
website with the final recommendation.
Responses to general/policy-level
issues
Concerns about the appropriateness of
authorisation to come to a higher level of safety
 Priority setting approach does not reflect whether or not

authorisation is the most appropriate Community wide
instrument to address possible concerns related to the
substance
 Workshop on “the candidate list and authorisation” in
January 2009 concluded that in future it would be
beneficial if the MS (or COM) would document the
reasons for selecting one of these processes
(restriction – authorisation) which could be discussed
before finalising the work on an Annex XV dossier
Responses to specific comments
comments
Reminder on Authorisation procedure steps
Stage in the authorisation Actor Considered issues
process
Before the submission of an MS / COM The most appropriate risk

Annex XV dossier management instrument
Identification of a SVHC / MS/ECHA -> Hazard

inclusion on the Candidate List MSC
Prioritisation and Annex XIV ECHA / MSC PBT/vPvB
recommendation Indication of exposure
Other factors (e.g. grouping)
(Authorisation application) (applicant->) Control of risks?
Authorisation decision RAC/SEAC -> Suitable alternatives available?
COM Socio-economic benefits of the
continued use?
Responses to general/policy-level
issues
Concerns about substances imported via (semi)-

finished products and potential impact on
competitiveness of EU-based companies
 Import of articles is indeed not directly affected by the

authorisation requirement, a restriction process has to
be applied if there is a need to restrict such import
 After the sunset date ECHA is obliged to consider
whether the substance in articles poses a risk and, if
yes, prepare an Annex XV restriction dossier
• Most of comments were requests for exemptions
• Furthermore, some:
• requests for different transitional arrangements
• proposals for review periods
Responses to specific comments on
exemptions
Main cases / arguments
1 Use out of scope of authorisation
2 Other legislation
- Community legislation
- recommended exemptions: Annex XVII
- National legislation
- Standards, agreements
- Not specified
3 Low level of risk and/or suitable alternatives not available
exemptions (scope)
Uses exempted from authorisation
- Scientific research and development (Art 56(3), definition art 3.23)
- Intermediates (Art 2(8)(b) and 2(1)(c), definition Art 3.15)
- Mineral oil fuels in combustion plants (Art 56(4)(d))
When within the scope of the relevant Community legislation

- Medicinal products (Art 2(5)(a))
- Food and feedingstuff (Art 2(5)(b))
- Pesticides (Art 56(4)(a))
- Biocides (Art 56(4)(b))
- Motor fuels (Art 56(4)(c))
When the substance is identified on account of CMR properties or as substance of

equivalent concern for human health and within the scope of the relevant
Community legislation
- Cosmetic products (Art 56(5)(a))
- Food contact materials (Art 56(5)(b))
exemptions (scope)
Uses exempted from authorisation

– Obviously no need for an entry specific exemption in Annex XIV
– Is a substance used as an intermediate or in scientific research
and development?
• Actors to assess whether the use is in accordance with the
definitions in Art 3 and provide evidence, if requested
• Support, as appropriate, by national authorities, ECHA
and/or COM
– Is the use within the relevant Community legislation?
• Actors to assess and provide evidence, if requested
• Support, as appropriate, by national authorities, (ECHA)
and/or COM
exemptions (legislation)
Other legislation
Community legislation
i) Further assessment needed
– for use in medical devices (ref Art (60(2) and 62(6))
– for use in primary/immediate packaging of medicinal
products/active substances
ii) On the basis of available information ECHA does not see grounds
for recommending an exemption,
– e.g. IPPC-Directive
– e.g., Chemical Agents Directive, Carcinogens and mutagens Directive
exemptions
General approach: ECHA assessed these requests

against Art. 58(2) criteria, on the basis of available info.
Art. 58(2) of the REACH Regulation:

“Uses or categories of uses may be exempted from the
authorisation requirement provided that, on the basis of
the existing specific Community legislation imposing
minimum requirements relating to the protection of
human health or the environment for the use of the
substance, the risk is properly controlled….”
• Considerations for exemptions on the basis of Article 58(2)
– Specific Community legislation imposing minimum requirements
• It addresses the use (or categories of use) that is proposed to be
exempted
– Definition of use comparable with REACH definition of use
– Exemptions from the other legislation to be similar/comparable with
REACH
• It properly controls the risks (arising from the intrinsic properties
lead to identification as SVHC) from the use
– Use in question refers specifically to that substance to be included in
Annex XIV
• It imposes minimum requirements for control of risks
– The MS may adopt more stringent but not less stringent measures
– Has to define the measures to be implemented by the actors and to be
enforced by the authorities ensuring the similar minimum level of
control of risks throughout the EU and that this level can be
regarded as proper.
Comments questioning the recommended

exemptions
(based on entries in Annex XVII)
– Annex XVII exemptions should not be
automatically taken over?
– Considerations to include an exemption in
Annex XVII and whether to grant
authorisation are not necessarily the same
– Is the substance used in these applications?
– Is it certain that there are no alternatives?
National legislation,
Standards,
Voluntary agreements, or
Legislation not specified
 On the basis of the available information no grounds for an

exemption under Art 58(2)
comments (no risk / alternatives)
Art 58(2) does not allow an exemption on the basis of

– low risk / adequate control of risk
– non-availability of alternatives
– risks related to transfer to alternatives
– economic consequences of the authorisation requirement / non-
authorisation
Requests for different transitional arrangements

 longer transitional arrangements: in many cases, misunderstanding
from the submitters on how and when arguments on low
releases/risks and/or lack of alternatives/(hazard) profile of possible
alternatives will be considered
 shorter transitional arrangements: reference to general approach
applied
Proposals for review periods
 confusion between eventual upfront general review periods for

certain uses (in Annex XIV – art. 58(1)(d)) and systematic
use/applicant-specific time-limited review periods (in “individual”
authorisation decisions – art. 60(8) & 60(9)(e)
Next steps
• MSC opinion will be published on ECHA website asap
• ECHA’s finalised recommendation will be sent to the Commission by 1 June
2009 and published on ECHA’s website
– The recommendation = “Table” for Annex XIV
– Justification documentation
• General priority setting approach
• General approach for Annex XIV Recommendation
• Justification document for inclusion/non-inclusion of each substance from
the candidate list to the authorisation list
• Response to comments (RCOM) tables
• MSC opinion and the declaration of six members expressing concerns on
including HBCDD in the authorisation list
• Regulation of the Commission on Annex XIV based on the decision of the

Regulatory Committee
• Applications for authorisation addressed to ECHA
– Opinion of Risk Assessment Committee and Socio-economic Analysis
Committee to the Commission
• Commission decisions on granting/not-granting authorisations for different
uses

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First steps of authorisation

Substance Intrinsic Transitional arrangements Rev Exempted (categories of) uses

CAS number: 101-77-9

• from 25 countries (19 EU-countries + Norway;

• 12 MSCAs (incl. NO) submitted comments

• the most commented substances: phthalates (33

 Priority setting approach does not reflect whether or not

Before the submission of an MS / COM The most appropriate risk

Identification of a SVHC / MS/ECHA -> Hazard

Concerns about substances imported via (semi)-

 Import of articles is indeed not directly affected by the

1 Use out of scope of authorisation

3 Low level of risk and/or suitable alternatives not available

When within the scope of the relevant Community legislation

When the substance is identified on account of CMR properties or as substance of

Uses exempted from authorisation

General approach: ECHA assessed these requests

Art. 58(2) of the REACH Regulation:

Comments questioning the recommended

 On the basis of the available information no grounds for an

Art 58(2) does not allow an exemption on the basis of

Requests for different transitional arrangements

Proposals for review periods

 confusion between eventual upfront general review periods for

• Regulation of the Commission on Annex XIV based on the decision of the

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