EUROPEAN COMMISSION
Directorate-General for Environment
Green Economy
Chemicals
Directorate-General for Internal Market, Industry, Entrepreneurship and SME's
Resources Based, Manufacturing and Consumer Goods Industries
REACH
Chemicals Industry
Brussels, 18 March 2015
Doc. CA/15/2015
17th Meeting of Competent Authorities for REACH and CLP (CARACAL)
26 – 27 March 2015
Room Sicco Mansholt (MANS), Building CHARLEMAGNE, Brussels,
Belgium
Concerns:
Streamlining and simplification of authorisation
Agenda Point:
5.1c (CA session) and 20.1 (Open session)
Action Requested:
For information.
RESPONSES TO WRITTEN COMMENTS TO PAPERS CACS/40/2014 AND CA/81/2014 RECEIVED AFTER CARACAL 16
The Commission would like to thank all authorities and stakeholders who submitted comments on the above mentioned papers. Most of the comments
concerning the case simplification for low volume case have already been taken into account for the preparation of the public consultation currently ongoing1. Other comments have been considered when drafting the paper CA/16/2015 for CARACAL 17. This RCOM intends to answer to comments on other
topics.
COMMEN
TATOR
OBSERVATION
COM RESPONSE
Simplification of
authorisation and
implementing act
BE, FR, SE,
AT,
CHEMSEC,
EEB, HEAL
An implementing act cannot reduce the
legal obligations of REACH. REACH clearly
states that an application for authorisation
needs to contain a CSR, AoA and SEA.
The Commission will propose an implementing act on simplification and
streamlining of application for authorisation in full respect of the existing
REACH legal requirements. The possible simplification in the special case
‘low volumes’ is in the ongoing public consultation illustrated via
examples of draft templates for CSR, AoA and SEA that fulfil the
requirements of REACH. For a general streamlining of all applications for
authorisation, the Commission’s aim is to give an indication of which
elements of CSR, AoA and SEA and what type of information are needed
as a minimum to prove the case, while avoiding overloading the dossier
with unnecessary information (see paper CA/16/2015).
Simplification and
negative effect on
substitution
CHEMSEC,
EEB
The Commission intends to reduce the
burden for companies who wish to
continue using SVHCs, but is making no
proposal to encourage innovation via
substitution or to reach companies who
already substituted.
The Commission does not intend to prevent substitution, which is the
main objective of authorisation. Simplification is addressing some very
specific cases where the potential for actually substituting the use of the
Annex XIV substances is very limited, while the risks from continued use in
these low volumes are comparatively small and/or decreasing anyway
over time (low volumes and spare parts). Streamlining is aiming at
TOPIC
1
http://ec.europa.eu/yourvoice/consultations/index_en.htm
reducing the burden to prepare some parts of the application and,
subsequently, process them by authorities in cases where the substance
cannot, for the time being, be substituted.
Shift of burden of
proof
CHEMSEC,
EEB, HEAL
Definition of uses
SE,
CHEMSEC,
EEB, HEAL
Definition of uses
FR
By providing help to prove adequate
control, lack of alternatives, benefits
outweighing the risk, Commission and
ECHA are doing the applicant’s job and
shift the burden of proof. They should be
helping companies to substitute Annex XIV
substances, so that they do not have to
apply for authorisation.
The Commission together with ECHA intends to further explore how the
existing tools and initiatives promoting substitution of SVHCs and
encouraging innovation could be developed and complemented, and a
better communication on these subjects promoted.
Nevertheless, the decision to apply is a business decision that needs to be
made by the companies concerned. The Commission does not intent to
provide “pre-compiled” dossiers. Please see answers to previous
comments on the aims of simplification and streamlining. If ECHA receives
more “fit for purpose” dossiers, targeted just at all the essential elements
and not containing voluminous and superfluous information, this will also
reduce the burden on the authorities that need to assess and decide on
the application and for stakeholders who wish to comment during the
public consultations.
The Commission believes that the definition of uses should be a case-bycase decision of the applicant that is at the same time also his business
decision. There are cases where the definition can be very precise, for
example in case of a downstream user application for a very specific use.
There are also cases where many downstream users share a use and need
an authorisation. In such a case, there are clear advantages for submission
Commission and ECHA should consider the of an upstream application to cover many downstream users because a
possibility to group applications for the separate application by all downstream users would be much more costly
same uses, especially in case of SMEs.
and less efficient also from the authorities’ perspective. There is a need to
further reflect on the specificities and generalities of an upstream
application, including the aspects related to the scope and definition of
If ECHA and Commission suggest a broader
definition of uses, this will make it more
difficult to make a robust AoA and to
provide
relevant
information
on
alternatives during the public consultation.
3
uses.
CHEMSEC,
EEB, HEAL
Art. 58(2)
exemptions
FR,
SE, Various concerns on the possible There is indeed a need for clarification under which conditions Art. 58(2)
CHEMSEC,
exemptions to authorisation on the basis could apply. So far decisions have been made on a case by case basis as
part of the prioritisation process and at the moment of inclusion of
EEB, HEAL
of Art. 58(2).
substances in Annex XIV. A pending court case on the inclusion of
Cefic, ESIA
Request to clarify possible exemptions
chromium trioxide in Annex XIV, which concerns the applicability of the
exemption on the basis of concentration limits set up under worker's
protection legislation, should help in this process.
Art. 58(2)
exemptions
Such public consultation is against REACH
intentions. The socio-economic elements
are to be evaluated in the application
phase. It is a duplication of work and an
unnecessary and additional burden for
companies at a very advanced point in
time because the same information is to
be provided when companies are applying
for
authorisation.
It
undermines
innovation by companies who produce
alternatives.
The call for information on socio-economic elements prior to inclusion of
substances in Annex XIV was a first call for information of this kind, where
the Commission want to explore whether and how some socio-economic
elements could be taken into account at this stage of the process. By this
call, the Commission does not intend to replace the socio-economic
analysis of the application phase and therefore it did not ask for companyspecific socio-economic information. It asked for evidence of impacts
(both positive and negative) of inclusion in Annex XIV considering the
various uses of a substance. The Commission is currently reviewing the
information received on the substances proposed for ECHA’s draft 6th
recommendation.
Public consultation
on socio-economic
elements prior to
inclusion of
substances in
Annex XIV
This topic is the subject of an internal Commission discussion among all
relevant services and was also broached at the workshop with Member
States authorities and stakeholders on 18 November 2014. Further followUse of OEL as DNELs would reduce up is ongoing. Among others RAC and SCOEL will be asked to have a joint
administrative burden for companies.
discussion on methodologies for deriving DNELs and OELs, and guidance
for economic operators might need to be revised.
OEL and DNELs
FR, SE, EEB, Concerns on the use of OELs as DNELs.
HEAL
OEL and DNELs
ESIA,
Orgalime
Simplification for
BE, AT, NL, Various concerns and suggestions on the As explained in the paper CA/16/2015, there will be further discussion on
4
type-approval and
other
authorisation
systems
FR
possibility for simplification in such cases.
how some dossier elements for application for uses subject to typeapproval /certification/authorisation can be streamlined.
Role of RAC and
SEAC for simplified
applications
NL
There is a need to discuss how RAC and This topic will be further discussed in the respective ECHA Committees.
SEAC will evaluate the simplified
applications.
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5