Commission Implementing Regulation (EU) 2016/9Show full title

Commission Implementing Regulation (EU) 2016/9

of 5 January 2016

on joint submission of data and data-sharing in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard 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(1), and in particular Article 132 thereof,

Whereas:

(1) For the purposes of registration of substances, Titles II and III of Regulation (EC) No 1907/2006 include provisions that require manufacturers and importers to share data and to jointly submit information to the Agency.

(2) The experience acquired by authorities through the 2010 and 2013 registration deadlines set out in Article 23 of Regulation (EC) No 1907/2006 for phase-in substances, together with information received from stakeholders directly and via the REACH registration workshop that took place in Brussels on 10-11 December 2013, indicate that the provisions of Regulation (EC) No 1907/2006 on data-sharing and joint submission have not been used to their full potential, their implementation falling short of expectations. This has been especially prejudicial to small and medium size enterprises.

(3) In order for the system of data-sharing, established by Regulation (EC) No 1907/2006, to operate effectively, it is necessary to promote good management practices and to ensure the efficient functioning of agreements pertaining to sharing such data. Rules should therefore be established for an efficient implementation of that Regulation as regards data sharing.

(4) Costs relating to sharing and jointly submitting information, in accordance with Articles 11(1), 19(1), 27(3) and 30(1) of Regulation (EC) No 1907/2006, should be determined in a fair, transparent and non-discriminatory manner.

(5) It is necessary to clarify that in accordance with Articles 27(3) and 30(1) of Regulation (EC) No 1907/2006, both administrative costs and costs related to information requirements should only be shared where those costs are relevant to the information that a party is obliged to submit for registration under that Regulation. Costs relating to information requirements include any cost that was required for performing an existing study or is required for performing a new study, whether relating to preparing the necessary specifications, contracting with a laboratory or monitoring its performance. Costs of fulfilling a REACH information requirement not involving testing studies should also be included.

(6) To ensure that data is shared in a transparent and effective manner, all agreements to share data for the purposes of Regulation (EC) No 1907/2006 should be structured in a way that all relevant costs are clearly described and identifiable. However, where parties to data-sharing agreements that already exist on the date of entry into force of this Regulation are satisfied with the functioning of such agreements, it should be possible to waive the obligation to itemise costs when all parties consent.

(7) In order to ascertain that the costs of sharing data are justified and are adequately distributed between the parties to a data-sharing agreement, annual records of costs incurred and compensation received should be kept by those parties. In accordance with Articles 27(3) and 30(1) of Regulation (EC) No 1907/2006, parties to existing data-sharing agreements should make every effort to establish proof of costs incurred before the entry into force of this Regulation.

(8) To ensure consistency with Article 25(3) of Regulation (EC) No 1907/2006 and to ensure that there is documentation of the cost of any study that may be subject to a data-sharing agreement, those annual records should be kept for a minimum of 12 years following the submission of a study in the framework of a registration under that Regulation

(9) A data-sharing agreement should include a model for sharing all relevant costs. A reimbursement mechanism should be envisaged in each cost-sharing model to allow for potential adjustment of the share of costs that each registrant pays when other registrants join that agreement at a later stage.

(10) In order to ensure that no unnecessary administrative burden is placed on parties to data-sharing agreements that already exist on the date of entry into force of this Regulation, those parties should be allowed to waive the obligation to include a reimbursement mechanism if all parties to the agreement consent. In the case of such agreements, potential registrants who intend to join the existing agreement should be allowed to request the inclusion of a reimbursement mechanism.

(11) In the interest of providing legal certainty, it should be clarified that in accordance with Article 50(4) of Regulation (EC) No 1907/2006, the costs associated with a substance evaluation decision may also apply to registrants who have already ceased their activities pursuant to paragraph 2 or 3 of Article 50 of that Regulation.

(12) The principle of ‘one substance, one registration’, which underpins the operation of Titles II and III of Regulation (EC) No 1907/2006, should be reinforced by emphasising the role of the Agency in ensuring that all submissions of information regarding the same substance are part of the same registration under that Regulation.

(13) Where tests on vertebrate animals are not required for the purposes of a party's registration under Regulation (EC) No 1907/2006, it should be clarified that that party is not obliged to share data with other registrants of the same substance and may choose to submit separately the information referred to in Article 10(a) in accordance with Article 11(3) or 19(2) of that Regulation.

(14) In order to ensure consistency with the principle of ‘one substance, one registration’, the Agency should ensure that a separate submission of the information referred to in Article 10(a), justified under Article 11(3) or 19(2) of Regulation (EC) No 1907/2006, is still part of the existing registration for that substance.

(15) In order to promote the development and use of alternative methods for the assessment of hazards of substances and to minimise animal testing, this Regulation encourages the sharing of relevant (animal and non-animal) studies that are conducted on a substance which is structurally similar to the substance being registered (grouping or read-across).

(16) The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION:

(1)

OJ L 396, 30.12.2006, p. 1.