Date: 2020-04-08Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2020/507 of 7 April 2020 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the percentage of registration dossiers to be selected for compliance checking (Text with EEA relevance)
Executive Summary:
Commission Regulation (EU) 2020/507 amends Regulation (EC) No 1907/2006 (REACH) regarding the percentage of registration dossiers selected for compliance checking by the European Chemicals Agency (ECHA). This change increases the minimum percentage to enhance compliance with information requirements. The target of 20% should be achieved by December 31, 2023, for registrations in tonnage bands of 100 tonnes or more per year and by December 31, 2027, for registrations in tonnage bands of less than 100 tonnes per year.
Key Points / Main Content:
Compliance Checking Percentage Increase:
* The minimum percentage of registration dossiers to be checked for compliance is increased from 5% to 20% of the total received by the Agency for each tonnage band by the 2018 deadline.
Deadlines for Achieving Target:
* For registrations in tonnage bands of 100 tonnes or more per year: the 20% target should be achieved by December 31, 2023.
* For registrations in tonnage bands of less than 100 tonnes per year: the 20% target should be achieved by December 31, 2027.
Priority for Dossier Selection:
* When selecting dossiers for compliance checking, the Agency shall give priority to dossiers meeting at least one of the criteria.
Amendment to Regulation EC No 1907/2006:
* Article 41(5) of Regulation EC No 1907/2006 is amended to reflect the new compliance checking percentages and deadlines.
Entry into Force:
* This Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
European Chemicals Agency (ECHA):
* Impact: ECHA is required to increase the percentage of registration dossiers selected for compliance checking.
* Action Required: ECHA needs to implement the increased compliance checking rate, prioritizing dossiers based on set criteria, and meet the deadlines for the respective tonnage bands.
Registrants:
* Impact: Registrants face a higher likelihood of their registration dossiers being selected for compliance checks.
* Action Required: Registrants should ensure their registration dossiers are fully compliant with Regulation EC No 1907/2006 to avoid potential requests for further information and to ensure effective achievement of the objectives of Regulation EC No 1907/2006.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
COMMISSION REGULATION EU 2020/507: A regulation by the European Commission amending Regulation EC No 1907/2006.
Regulation EC No 1907/2006: Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
European Parliament: One of the legislative bodies of the European Union.
Council of the European Union: One of the legislative bodies of the European Union.
European Chemicals Agency (ECHA): An agency of the European Union that implements REACH regulation.
Directive 1999/45/EC: A directive amended by Regulation EC No 1907/2006.
Brussels: The city where the regulation was adopted.
8.4.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 110/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) 2020/507
of 7 April 2020
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards
the percentage of registration dossiers to be selected for compliance checking
(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 41(7) thereof,
Whereas:
(1) In order to ensure that registration dossiers comply with Regulation (EC) No 1907/2006, Article 41 of that
Regulation requires the European Chemicals Agency (‘the Agency’) to select a specific percentage of registration
dossiers for compliance checking. This check may lead to a draft decision requiring the registrant(s) to submit any
information needed to bring the registration(s) into compliance with the relevant information requirements.
(2) The assessment by the Agency(2) and the Commission(3) concerning the operation of Regulation (EC)
No 1907/2006 as well as a study conducted by the German competent authorities(4) indicate that likely a
significant number of the registration dossiers are non-compliant, hampering the effective achievement of the
objectives of Regulation (EC) No 1907/2006.
(3) In the ‘General Report on the operation of REACH and review of certain elements’, the Commission identified non-
compliance of registration dossiers as an issue requiring urgent action.
(4) Following the expiry of the last registration deadline, better advance planning with regard to compliance checks is
possible based on improved knowledge of the actual numbers of registered substances and the dossier evaluation
experience acquired by the Agency.
(1) OJ L 396, 30.12.2006, p. 1.
(2) European Chemicals Agency’s annual evaluation reports and reports on the operation of the Regulation (EC) No 1907/2006: https://
echa.europa.eu/about-us/the-way-we-work/plans-and-reports
(3) Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee
‘Commission General Report on the operation of REACH and review of certain elements’, COM(2018) 116 final.
(4) https://www.bfr.bund.de/cm/349/data-quality-of-environmental-endpoints-in-registrations.pdfL 110/2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 8.4.2020
(5) Following consultation with the Agency as reflected in the REACH evaluation Joint Action Plan(5) agreed by the
Commission services and ECHA, which the Council has requested in its Conclusions of 26 June 2019(6), the
Commission considers that in order to enhance compliance with the relevant information requirements, the
minimum percentage of registration dossiers to be checked for compliance on all elements listed in Article 41(1) of
Regulation (EC) No 1907/2006 should be increased from 5 % to 20 % of the total received by the Agency for each
tonnage band by the 2018 deadline. Such percentage is considered realistic for the Agency in view of its resources.
(6) In the Joint Action Plan agreed by the Commission services and ECHA, it has been agreed that the target of 20 %
should be achieved by 31 December 2023 for registrations in tonnage bands of 100 tonnes or more per year and
by 31 December 2027 for registrations in tonnage bands of less than 100 tonnes per year, submitted by the 2018
deadline.
(7) Regulation (EC) No 1907/2006 should therefore be amended accordingly.
(8) 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:
Article 1
In Article 41(5) of Regulation (EC) No 1907/2006, the first and the second sentences are replaced by the following:
‘To check compliance of registration dossiers with this Regulation, the Agency shall select, until 31 December 2023, a
percentage of those dossiers no lower than 20 % of the total received by the Agency for registrations in tonnage bands
of 100 tonnes or more per year.
The Agency shall, until 31 December 2027, also select a percentage no lower than 20 % of the total received by the
Agency for registrations in tonnage bands of less than 100 tonnes per year.
When selecting dossiers for compliance checking, the Agency shall give priority, but not exclusively, to dossiers meeting
at least one of the following criteria:’.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 April 2020.
For the Commission
The President
Ursula VON DER LEYEN
(5) REACH Evaluation Joint Action Plan – Ensuring compliance of REACH registrations –
https://echa.europa.eu/documents/10162/21877836/final_echa_com_reach_evaluation_action_plan_en
(6) Towards a Sustainable Chemicals Policy Strategy of the Union – Council conclusions of 26 June 2019, http://data.consilium.europa.
eu/doc/document/ST-10713-2019-INIT/en/pdf – point 18.