ECHA is reporting on the progress made in 2019 in dossier and substance evaluation in line with Article 54 of REACH.

 

 

Significant increase in compliance checks performed in 2019

With the REACH Evaluation Joint Action Plan adopted in 2019, ECHA prepared the basis for obtaining information on substances where it is unclear whether their use is safe or not. In 2019, ECHA has tackled non-compliant information on chemicals head on, sped up the dossier evaluation process and significantly raised the percentage of dossiers checked.

In 2019, ECHA carried out 301 full compliance checks covering 274 unique substances – an increase of more than 50 % compared to the 2018 figures (where 196 full checks covering 182 substances were done).

In addition, ECHA performed 89 targeted compliance checks on 64 substances (i.e. to clarify the substance identity). ECHA also prioritises dossiers for compliance check that registrants have submitted separately under Article 11(3) of REACH. Registrants may submit information separately if they can justify why the costs of submitting jointly are disproportionate, why submitting the information jointly may lead to the disclosure of commercially sensitive information, or why they disagree with the lead registrant on the selection of information.

In 2019, ECHA checked 32 dossiers for compliance covering 18 substances submitted by members of joint submissions who ‘opted-out’ and sent 25 draft decisions on 16 substances. Prioritising such dossiers for compliance continues to ensure a level playing field and to support the functioning of the internal market.

To sum up, in 2019, ECHA carried out 390 checks on 3 750 dossiers covering 338 unique substances.

New addressee policy giving more clarity for registrants

Since 2019, ECHA has started sending its draft decisions to all affected members of the joint submission with non-compliant dossiers. This is a change to the earlier practice when only the lead registrant of the joint submission was contacted and expected to inform other relevant members on the outcome of ECHA’s assessment.

By contacting all affected members of the joint submission and setting out clearly how the information requirements apply at each tonnage band, ECHA gives registrants better legal certainty on what their individual legal obligations are, which helps ensure a level-playing field for all registrants in the joint submission. All recipients are required to comply with their respective information requirements, and need to share existing/new data while respecting their legal obligation to avoid unnecessary (vertebrate animal) testing.

Simplification of decisions

Since early 2019, ECHA has worked to simplify evaluation decisions aiming to provide more focused and clearer justifications on why information is still required from all registrants to compel them to comply with their obligations.

To further help registrants, the requests are now structured in different appendices corresponding to the respective REACH annexes that contain the requirements concerned. ECHA’s justifies its requests for information in various appendices and addresses the aspects of its assessment that are relevant for several incompliances (e.g. read-across adaptation, strategy for aquatic testing or PBT assessment) in a preliminary appendix.

ECHA will continue to work to simplify its decisions in 2020, also taking into account feedback received from companies.

Outputs of dossier assessments in 2019

Concluded assessments: ECHA performed 489 compliance checks (CCHs) and testing proposal examinations (TPEs), covering 404 unique substances. ECHA issued 377 draft decisions: 296 on compliance checks and 81 on testing proposal examinations. The selection of registrations for compliance check was mainly based on (groups of) substances raising potential hazard- or exposure-based concerns.

Carry-over to the following year

For the draft decisions sent in 2019, the decision-making process continued and was finalised in 2019 or will be completed in 2020. To sum up, ECHA referred 337 draft dossier evaluation decisions to the Member State competent authorities for further decision making in 2019. ECHA also terminated 19 compliance check cases and three testing proposal examinations after a draft decision was sent, as scientifically-relevant data or important administrative changes led to the ongoing decision-making procedure being terminated.