Proposal for a Directive of the European Parliament and of the Council on the Restriction

/ UNION EUROPEENNE DE L’ARTISANAT ET DES PETITES ET MOYENNES ENTREPRISES
EUROPÄISCHE UNION DES HANDWERKS UND DER KLEIN- UND MITTELBETRIEBE
EUROPEAN ASSOCIATON OF CRAFT, SMALL AND MEDIUM-SIZED ENTERPRISES
UNIONE EUROPEA DELL’ ARTIGIANATO E DELLE PICCOLE E MEDIE IMPRESE

UEAPME amendments

to be presented to the European Parliament

in the first reading on the proposal concerning the

Registration, Evaluation, Authorisation and Restriction of

Chemicals (REACH), establishing a European Chemicals

Agency and amending Directive 1999/45/EC and Regulation

(EC) {on Persistent Organic Pollutants}

MAISON DE L'ECONOMIE EUROPEENNE - RUE JACQUES DE LALAING 4 - B-1040 BRUXELLES

TEL ÷32 2 230.75.99 - FAX ÷32 2 230.78.61 - E-MAIL

Amendment 1

TITLE I – GENERAL ISSUES

Chapter 2 – Definitions

Article 3, paragraph 25

European Commission proposal

Proposed amendment

Identified use means a use of a substance on its own or in a preparation, or a use of a preparation, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user and that is covered in the safety data sheet communicated to the downstream user concerned; / Identified use means a use of a substance expressed by means of exposure categories and/or on the basis of the chemical property of the substance itself on its own or in a preparation, or a use of a preparation, that is intended by an actor in the supply chain, or that is made known to him in writing by an immediate downstream user and that is covered in the safety data sheet communicated to the downstream user concerned;

Justification

A too stringent definition of use not linked to the chemical properties of the substance could create unnecessary registrations/notifications of uses

Amendment 2

TITLE I – GENERAL ISSUES

Chapter 2 – Definitions

Article 3, paragraph 30 (new)

European Commission proposal

Proposed amendment

Small and Medium Enterprise (SME) according to the definition included in EU Recommendation of 6 may 2003. (OJ L124 of 20 may 2003)

Justification

Useful to define SMEs in order to identify them for specific ad hoc procedures.

Amendment 3

TITLE II – REGISTRATION OF SUBSTANCES

Chapter 1 – Scope

Article 4, paragraph 2

European Commission proposal

Proposed amendment

2. The following shall be exempted from this Title:
(a)substances included in Annex II;
(b)substances covered by Annex III;
(c)substances on their own or in preparations, registered in accordance with this Title, exported from the Community by an actor in the supply chain and re-imported into the Community by another actor in the same supply chain who shows that:
(i)the substance being re-imported is the same as the exported substance;
(ii)he has been provided with the information in accordance with Articles 30 and 31 relating to the exported substance. / 2. The following shall be exempted from this Title:
(a) substances included in Annex II;
(b)substances covered by Annex III;
(c)substances on their own or in preparations, registered in accordance with this Title, exported from the Community by an actor in the supply chain and re-imported into the Community by another actor in the same supply chain who shows that:
(i)the substance being re-imported is the same as the exported substance;
(ii)he has been provided with the information in accordance with Articles 30 and 31 relating to the exported substance.
(d)Polymers.

Justification

Polymers should be completely excluded from REACH, not only from the registration procedure. An appropriate regulation or directive will deal with polymers when it is decided to regulate on them.

Amendment 4

TITLE II – REGISTRATION OF SUBSTANCES

Chapter 2 – General obligation to register and information requirements

Article 6, paragraph 2

European Commission proposal

Proposed amendment

Any producer or importer of articles shall notify the Agency of any substance contained in those articles in accordance with paragraph 3, if all the following conditions are met:
(a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year;
(b) the substance meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC;
(c) the producer or importer knows, or it is made known to the producer or importer, that the substance is likely to be released under normal and reasonably foreseeable conditions of use, even though this release is not an intended function of the article;
(d) the quantity of the substance released may adversely affect human health or the environment. / Any producer or importer of articles shall notify the Agency of any substance contained in those articles in accordance with paragraph 3, if all the following conditions are met:
(a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year;
(b) the substance meets the criteria for authorizations and restrictions of this regulation ;
(c) the producer or importer knows, or it is made known to the producer or importer, that the substance is likely to be released under normal and reasonably foreseeable conditions of use, even though this release is not an intended function of the article;
(d) the quantity of the substance released may adversely affect human health or the environment.

Justification

Only very dangerous substances should be notified in order not to make the requirement too burdensome for enterprises while guaranteeing the protection of health and safety.

Amendment 5

TITLE II – REGISTRATION OF SUBSTANCES

Chapter 2 – General obligation to register and information requirements

Article 9, paragraph a

European Commission proposal

Proposed amendment

A registration required by Article 5 or by Article 6(1) or (4) shall include all the following information in the format specified by the Agency in accordance with Article 108:
(a) a technical dossier including:
(i) the identity of the manufacturer(s) or
importer(s) as specified in section 1 of
Annex IV;
(ii) the identity of the substance(s) as
specified in section 2 of Annex IV;
(iii) information on the manufacture and
use(s) of the substance as specified
in section 3 of Annex IV; this
information shall represent all the
registrant’s identified use(s);
(iv) the classification and labelling of the
substance as specified in section 4 of
Annex IV;
(v) guidance on safe use of the
substance as specified in Section 5
of Annex IV;
(vi) summaries of the information derived
from the application of Annexes V to
IX;
(vii) robust study summaries of the
information derived from the
application of Annexes V to IX, if
required under Annex I;
(viii) a statement as to whether or not
information has been generated by
testing on vertebrate animals;
(ix) proposals for testing where required
by the application of Annexes V to
IX;
(x) a declaration as to whether he
agrees that his summaries and
robust study summaries of the
information derived from the
application of Annexes V to
VIII with regard to tests not
involving vertebrate animals may
be shared against payment with
subsequent registrants; / A registration required by Article 5 or by Article 6(1) or (4) shall include all the following information in the format specified by the Agency in accordance with Article 108:
(a) a technical dossier including:
(i) the identity of the manufacturer(s) or
importer(s) as specified in section 1 of
Annex IV;
(ii) the identity of the substance(s) as
specified in section 2 of Annex IV;
(iii) information on the manufacture and
use(s) of the substance as specified
in section 3 of Annex IV; this
information shall represent all the
registrant’s identified use(s);
(iv) the classification and labelling of the
substance as specified in section 4 of
Annex IV;
(v) guidance on safe use of the
substance as specified in Section 5
of Annex IV;
(vi) summaries of the information derived
from the application of Annexes V to
IX;
(vii) robust study summaries of the
information derived from the
application of Annexes V to IX, if
required under Annex I;
(viii) a statement as to whether or not
information has been generated by
testing on vertebrate animals;
(ix) proposals for testing where required
by the application of Annexes V to
IX;

Justification

The principle of compulsory access to all data, in exchange of a fair compensation, prevents the creation of dominant positions in the market and limitation of competition.

Amendment 6

TITLE II – REGISTRATION OF SUBSTANCES

Chapter 2 – General obligation to register and information requirements

Article 12, paragraph 4

European Commission proposal

Proposed amendment

If a substance has already been registered, a new registrant shall be entitled to refer to studies and test reports, hereinafter “studies”, for the same substance submitted earlier, provided that he can show that the substance that he is now registering is the same as the one previously registered, including the degree of purity and the nature of impurities, and that he can submit a letter of access from the previous registrant(s) allowing the use of the studies. / If a substance has already been registered, a new registrant shall be entitled to refer to studies and test reports, hereinafter “studies”, for the same substance submitted earlier, provided that he can show that the substance that he is now registering is the same as the one previously registered, including the degree of purity and the nature of impurities, and that he submits a letter of access from the previous registrant(s).

Justification

Same as amendment 8. It is important to grant access to all data, related to vertebrates and others.

Amendment 7

TITLE II – REGISTRATION OF SUBSTANCES

Chapter 2 – General obligation to register and information requirements

Article 13, paragraph 4

European Commission proposal

Proposed amendment

If, as a result of carrying out steps (a) to (d) of paragraph 3, the manufacturer or importer concludes that the substance meets the criteria for classification as
dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:
(a)exposure assessment;
(b)risk characterisation.
The exposure assessment and the risk characterisation shall address all identified uses of the manufacturer or importer. / If, as a result of carrying out steps (a) to (d) of paragraph 3, the manufacturer or importer concludes that the substance meets the criteria for classification as
dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:
(a)exposure assessment;
(b)risk characterisation.

Justification

This represents an unnecessary repetition already expressed in Annex I.

Amendment 8

TITLE II – REGISTRATION OF SUBSTANCES

Chapter 2 – General obligation to register and information requirements

Article 14

European Commission proposal

Proposed amendment

Polymers are exempted from registration
under this Title. / Deleted

Justification

Linked to amendment 3.

Amendment 9

TITLE II – REGISTRATION OF SUBSTANCES

Chapter 6 – Transitional provisions applicable to phase-in substances

and notified substances

Article 21, paragraph 1

European Commission proposal

Proposed amendment

Article 19 shall not apply to the following substances for a period of 3 years after the entry into force of this Regulation:
(a)phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, categories 1 and 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation;
(b)phase-in substances manufactured in the Community or imported, in quantities reaching 1 000 tonnes or more per year per manufacturer or per importer, at least once following the
entry into force of this Regulation. / Article 19 shall not apply to the following substances for a period of 3 years after the entry into force of this Regulation:
(a) phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, categories 1 and 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation;
(c)phase-in substances manufactured in the Community or imported, in quantities reaching 1 000 tonnes or more and considered dangerous for human health according to Directive
67/548/CEE per year per manufacturer or per importer, at least once following the entry into force of this Regulation.

Justification

It is important not only to consider the quantities, but also their hazard to human health and the environment.

Amendment 10

TITLE II – REGISTRATION OF SUBSTANCES

Chapter 6 – Transitional provisions applicable to phase-in substances

and notified substances

Article 21, paragraph 2

European Commission proposal

Proposed amendment

Article 19 shall not apply for a period of 6 years after entry into force of this Regulation to phase-in substances manufactured in the Community or imported, in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation. / Article 19 shall not apply for a period of 6 years after entry into force of this Regulation to phase-in substances manufactured in the Community or imported, in quantities reaching 1000 tonnes or more per year and not dangerous for human health and the environment according to Directive 67/548CEE per manufacturer or per
importer, at least once following the entry into force of this Regulation; and to the substances produced or imported in the Community in quantities reaching 100 or more tonnes and considered dangerous for human health and the environment according to Directive 67/548/CEE.

Justification

Linked to amendment 9.

Amendment 11

TITLE II – REGISTRATION OF SUBSTANCES

Chapter 6 – Transitional provisions applicable to phase-in substances

and notified substances

Article 21, paragraph 3

European Commission proposal

Proposed amendment

Article 19 shall not apply for a period of 11 years after entry into force of this Regulation to phase-in substances manufactured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation. / Article 19 shall not apply for a period of 11 years after entry into force of this Regulation to phase-in substances manufactured in the Community or imported, in quantities reaching 1 tonne or more per year and to those manufactured or imported in the Community in quantities reaching 100 or more tonnes non dangerous to human health and the environment according to Directive 67/548/CEE per manufacturer or per importer, at least once following the entry into force of this Regulation

Justification

Linked to amendment 9.

Amendment 12

TITLE III – DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

Chapter 1 – Objectives and general rules

Article 23, paragraph 4

European Commission proposal

Proposed amendment

With regard to tests not involving vertebrate animals, this Title shall apply
to potential registrants only if previous registrants have made an affirmative declaration for the purposes of point (x)
of Article 9(a). / Deleted

Justification

Linked to Amendment 5.

Amendment 13

TITLE III – DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

Chapter 2 – Rules for non-phase-in substances

Article 24, paragraph 5

European Commission proposal

Proposed amendment

If the same substance has previously been registered less than 10 years earlier, the Agency shall inform the potential registrant without delay of the names and addresses of the previous registrant(s) and of the relevant summaries or robust study summaries of the studies, as the case may be, already submitted by them involving vertebrate animals.
These studies shall not be repeated.
The Agency shall also inform the potential registrant of the relevant summaries or robust study summaries of the studies, as the case may be, already submitted by the previous registrants not involving vertebrate animals for which the previous registrants have made an affirmative declaration for the purposes of point (x) of Article 9(a).
The Agency shall simultaneously inform the previous registrants of the name and address of the potential registrant. / If the same substance has previously been registered less than 10 years earlier, the Agency shall inform the potential registrant without delay of the names and addresses of the previous registrant(s) and of the relevant summaries or robust study summaries of the studies, as the case may be, already submitted by them.
These studies shall not be repeated.
The Agency shall simultaneously inform the previous registrants of the name and address of the potential registrant.

Justification

Linked to Amendment 5.

Amendment 14

TITLE III – DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

Chapter 2 – Rules for non-phase-in substances

Article 25, paragraph 1

European Commission proposal

Proposed amendment

In the case of substances previously registered less than 10 years earlier as referred to in Article 24(5), the potential registrant shall ask the previous registrant(s) for the information involving tests on vertebrate animals he requires in order to register. He may ask the registrants for any information on tests not involving vertebrate animals for which the previous registrants have made an affirmative declaration for the purposes of point (x) of Article 9(a). / In the case of substances previously registered less than 10 years earlier as referred to in Article 24(5), the potential registrant shall ask the previous registrant(s) for the information involving previously carried out tests he requires in order to register. He may ask also the registrants for any information on tests not involving vertebrate animals.

Justification

Linked to Amendment 5.

Amendment 15

TITLE III – DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

Chapter 2 – Rules for non-phase-in substances

Article 25, paragraph 3

European Commission proposal

Proposed amendment

If an agreement on the sharing of studies has been reached, the previous registrant(s) shall grant a letter of access to the potential registrant for the studies
concerned within two weeks of receipt of payment.
The new registrant shall refer to these studies in his registration dossier and shall submit the letter of access from the previous registrant(s). / If an agreement on the sharing of studies referred to in paragraph 1 has been reached, the previous registrant(s) shall grant a letter of access to the potential
registrant for the studies concerned within two weeks of receipt of payment.
The new registrant shall refer to these studies in his registration dossier and shall submit the letter of access from the previous registrant(s).

Justification

Linked to Amendment 5.

Amendment 16

TITLE III – DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

Chapter 2 – Rules for non-phase-in substances

Article 25, paragraph 4

European Commission proposal

Proposed amendment

If there is failure to reach such an agreement, the potential registrant may inform the Agency and the previous registrant(s) thereof at least 1 month after receipt, from the Agency, of the name and address of the previous registrant(s). / If there is failure to reach such an agreement, the potential registrant may submit a requestto the Agency, thereof at least 1 month after receipt of the name and address of the previous registrant(s), and inform them of this step, with a view to determine a fair and equitable compensation for the previous registrants, in accordance with paragraph 6.

Justification