Application
1. ECHA shall acknowledge receipt of the application submitted for the inclusion or removal of a starting substance, composition or constituent in the European positive lists to the applicant without undue delay.
2. The Commission may also initiate the application procedure by requesting ECHA to issue an opinion on the inclusion or removal of a starting substance, composition or constituent in the European positive lists.
3. Applicants not established in the Union shall appoint a representative established in the Union.
Applicants established in the Union, other than a relevant authority, may also appoint a representative.
4. In the case of a polymer intended as a starting substance or as organic cementitious constituent in the manufacture of cementitious materials other than admixtures, the application shall be made for any of the following:
(a)
the monomer in the case of a polymer not used as an additive;
(b)
the monomer or other reactant in the case of a polymer without a polymerised part below 1 000 Da which is used as an additive and is not obtained from microbial fermentation;
(c)
the pre-polymer, in the case of organopolysiloxanes used in the manufacture of silicones, rubbers, lubricants and surface treatment for fillers or in the case of coatings;
(d)
the polymer in all other cases.
5. In the case of a polymer intended for use as organic cementitious constituent in the manufacture of admixtures, the application shall cover all the monomers included in that polymer.
6. An application from a relevant authority may cover several starting substances, compositions, organic cementitious constituents, nanoforms or entries.
An application from a person other than a relevant authority shall cover only one starting substance, composition, organic cementitious constituent or nanoform.
7. The application shall contain the information listed in the Annex.
8. Where an application concerning an existing entry in one of the European positive lists is made after the first review referred to in Article 11(4), fourth subparagraph of Directive (EU) 2020/2184 is completed, the following shall apply:
(a)
by way of derogation from points (c) and (d) of the Annex, the information may be limited to a reference to the existing entry;
(b)
by way of derogation from points (e) to (i) of the Annex, in relation to already submitted information which complies with Implementing Decision (EU) 2024/365 the applicant is only required to submit any new or updated information.
9. In the case of an application by a relevant authority that concerns the review of an existing entry on a European positive list and that is justified by a concern for human health, the following shall apply:
(a)
by way of derogation from points (c) and (d) of the Annex, the information may be limited to a reference to the existing entry;
(b)
by way of derogation from points (e) to (i) of the Annex, the applicant is only required to address the concern for human health and submit any available information relevant to that concern.
10. The information referred to in point (h) of the Annex shall be submitted in the form of a robust study summary.
The information referred to in point (e) of the Annex, shall be submitted in the form of a study summary.
The information referred to in point (f) of the Annex shall be submitted in the form of a full study report complying with reporting requirements established by the corresponding EN standard or the standard determined by ECHA in accordance with Section 1, point 1.2 of Annex IV to Implementing Decision (EU) 2024/365.
Accordance check
1. ECHA shall assess whether the application from an applicant complies with the following:
(a)
it provides the information which is necessary and sufficient to be in accordance with Article 3(7);
(b)
it falls within the scope of Article 11(5) of Directive (EU) 2020/2184 and complies with Article 3(3) to (6).
2. Where the application does not fulfil the criterion of Article 4(1), point (a), ECHA shall notify the reasons to the applicant. The applicant shall bring its application into accordance within six months of the date of receipt of the reasons from ECHA.
Where the application does not fulfil the criterion of Article 4(1), point (b), ECHA shall notify this conclusion to the applicant. The applicant shall provide its comment within one month of the date of receipt of the reasons from ECHA.
3. Where the application does not comply with the requirements set out in Article 4(1), the procedure shall be terminated and ECHA shall notify it to the applicant.
4. ECHA shall inform the applicant of the accordance of its application without undue delay, indicating the date of completion of the accordance check.
5. Passing the accordance check is without prejudice to the opinion of the Committee for Risk Assessment in accordance with Article 6.
6. Where an application for review of an existing entry limited to the indication of the adoption of a harmonised classification and labelling under Section 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament andof the Council ( 3 ) or the inclusion of a substance in the Candidate List established under Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( 4 ) , ECHA may address that application directly to the Commission upon completion of the accordance check. In such case, Articles 5 and 6 of this Regulation shall not apply.
7. Where an application under Article 3(9) for which no updated information is available, ECHA may address that application directly to the Commission upon completion of the accordance check. In such case, Article 6 shall not apply.
8. Where applications to which Annex VI, Section 1, point 3 of Commission Implementing Decision (EU) 2024/365 may apply, ECHA may address the corresponding parts of that application directly to the Committee for Risk Assessment. In such case, Article 5 shall not apply.
9. Where an application is submitted to ECHA to review an entry from one of the positive lists referred to in Article 1 of Commission Implementing Decision (EU) 2024/367 ( 5 ) , that entry shall remain valid after its expiry date until the Commission decides on the application to review that entry provided that the application is submitted to ECHA no later than 18 months prior to the expiry date.
Consultation of interested parties
Within four weeks of the publication of an application on ECHA’s website, ECHA shall invite interested parties to submit scientific information.
Consultation of the applicant and opinion
1. The Committee for Risk Assessment shall provide an opinion on the risks to human health arising from the uses of the starting substance, composition or organic cementitious constituent covered by the application for on the basis of Implementing Decision (EU) 2024/365.
The Committee for Risk Assessment shall prepare a draft opinion taking into account any information submitted by interested parties within 10 months from the publication of the application or within 13 months from that publication in the case of a joint opinion in accordance with the below.
The draft opinion may be a joint draft opinion covering several applications in the following cases:
(a)
where they cover the same starting substance, composition or organic cementitious constituent;
(b)
where they cover the same non-intentionally added species;
(c)
where they are based on similar toxicological information;
(d)
where they raise similar considerations, in particular in case of absence of adverse effect identified;
(e)
in any other duly justified case.
2. ECHA shall send the draft opinion of the Committee for Risk Assessment to the applicant without undue delay. ECHA shall at the same time inform the applicant of the right to comment within 30 days.
3. The Committee for Risk Assessment shall finalise its opinion taking into account the comments from the applicant on the draft opinion, if any.
4. ECHA shall forward the opinion of the Committee for Risk Assessment to the applicant and the Commission without undue delay.
5. The Commission shall without undue delay, taking into account the opinion of the Committee for Risk Assessment, decide on the application in accordance with Article 11(4) of the Directive.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
