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Document 32021R0525
Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance)
Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance)
Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance)
C/2020/6771
OJ L 106, 26.3.2021, p. 3–28
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
26.3.2021 |
EN |
Official Journal of the European Union |
L 106/3 |
COMMISSION DELEGATED REGULATION (EU) 2021/525
of 19 October 2020
amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1) and in particular Article 85 thereof,
Whereas:
(1) |
Annexes II and III to Regulation (EU) No 528/2012 set out the information requirements for respectively active substances and biocidal products, which an application for approval of an active substance and an application for authorisation of a biocidal product need to fulfil. |
(2) |
It is necessary to modify the information requirements concerning active substances and biocidal products in order to take into account new methods for generating better information on toxicological properties (such as irritation, neurotoxicity, genotoxicity, etc.), new testing strategies favouring in vitro tests over in vivo tests in order to reduce testing on vertebrate animals and a testing strategy and methods for the determination of endocrine disrupting properties of substances in accordance with the criteria laid down in Commission Delegated Regulation (EU) 2017/2100 (2). |
(3) |
A dossier should be considered as complete if it complies with the requirements of Article 6(1) and Article 20(1), and in particular with the information requirements of Annexes II and III to Regulation (EU) No 528/2012. Pre-submission consultations between the applicant for the approval of an active substance or for the authorisation of a biocidal product and the evaluating competent authority contribute to the quality of the dossier and the progress of the evaluation process. The text of paragraphs 5 and 7, respectively, of points 2 of the introductory parts of Annexes II and III should be modified to ensure that the applicants include the conclusions of such consultation in the application to ensure the smooth operation of the evaluation procedure. |
(4) |
In accordance with Annexes II and III to Regulation (EU) No 528/2012, tests submitted for the purpose of the approval of an active substance or the authorisation of a biocidal product, respectively, are to be conducted in accordance with the methods described in Commission Regulation (EC) No 440/2008 (3). As there may be a period between the validation of an internationally recognised test method and its inclusion in Regulation (EC) No 440/2008, point 5 of the introductory parts of Annexes II and III to Regulation (EU) No 528/2012 should be amended to allow applicants to apply the most updated version of test methods. |
(5) |
Specific rules for the adaptation of the information requirements listed in the first column of the tables in Titles 1 and 2 of Annexes II and III to Regulation (EU) No 528/2012 are limited to concerns related to the recourse to testing on vertebrates. As some requirements listed in that first column do not include testing on vertebrates, the scope of adaptations listed in the third column of the tables listed in Titles 1 and 2 of Annexes II and III should be extended to cover cases where no testing on vertebrates is involved. |
(6) |
Point 2 of Title 1 of Annex II sets out the information requirements for the identification of the active substance. Those requirements need to be adapted in order to allow identification of active substances generated in situ. |
(7) |
Point 6 of Title 1 of Annexes II and III set out the requirements for the assessment of the effectiveness of an active substance or a biocidal product, respectively, against target organisms. Such effectiveness should also be demonstrated for the activity of an active substance in the absence of other substances that may affect the effectiveness. For treated articles, the effectiveness of the biocidal properties conferred to the article should be demonstrated. Moreover, the current provisions on unintended side-effects in point 6 do not specify on which type of organisms or objects information should be provided. Therefore, it should be clarified that any observation on undesirable or unintended side effects is to be limited to non-target organisms or objects and material to be protected by the active substance or biocidal product. |
(8) |
Article 62 of Regulation (EU) No 528/2012 requires that testing on vertebrate animals be undertaken only as a last resort. In setting data requirements for the approval of active substances and the authorisation of biocidal products, priority should be given to reliable in vitro methods as a substitute to in vivo methods requiring the use of vertebrate animals. The testing strategies included in Annexes II and III to Regulation (EU) No 528/2012 therefore need to be adapted to recently validated in vitro test guidelines of the Organisation for Economic Cooperation and Development (OECD) and other international standards. |
(9) |
The first mandatory requirement for following up on a positive in vitro gene mutation test is currently the in vivo unscheduled DNA synthesis (UDS) test, which has inherent limitations and low sensitivity. The Scientific Committee of the European Food Safety Authority (4) concluded in an opinion published in November 2017 that negative UDS results are not a proof that a substance does not induce gene mutation. The reference to the UDS test should, therefore, be removed and replaced by a reference to an appropriate in vivo somatic cell genotoxicity study. |
(10) |
The current data requirements in Annex II to Regulation (EU) No 528/2012 require a two-generation reproductive toxicity study (TGRTS) to be used to investigate the reproductive toxicity of a substance. That Annex furthermore stipulates that the extended one-generation reproductive toxicity study (EOGRTS) can be considered as an alternative approach to the TGRTS. The EOGRTS offers a number of advantages in comparison to the TGRTS as it assesses in addition to effects on the male and female reproductive system more toxicological effects linked to endocrine-disrupting mode of actions. Therefore, if there is no TGRTS available, an EOGRTS should be performed instead. |
(11) |
Exposure to neurotoxicants in utero or during childhood can contribute to a variety of neurodevelopmental and neurological disorders that manifest themselves only as a person ages, and may contribute to neurodegenerative diseases such as Parkinson’s or Alzheimer’s diseases. To address this concern, test guidelines to adequately screen and characterise active substances potentially toxic for the developing brain should be included in Annex II to Regulation (EU) No 528/2012. |
(12) |
The current structure of the information requirements relating to health data and medical treatment in points 8.12.1 to 8.12.8 of Title 1 of Annex II to Regulation (EU) No 528/2012 may lead to submission of overlapping information under a number of those points. The data requirements should therefore be streamlined to reduce compliance costs and unnecessary delays in the evaluation of applications. |
(13) |
An evaluation of the potential for unintended effects of substances on the immune system should be conducted. However, as no specific developmental immunotoxicity study is available in an OECD test guideline, relevant data should be required to be provided as additional data set. |
(14) |
Point 8.18 of Title 1 of Annex II to Regulation (EU) No 528/2012 duplicates the content of point 13 of that Title and should therefore be deleted. |
(15) |
Point 9.1.1 of Title 1 of Annex II to Regulation (EU) No 528/2012 should be amended in order to clarify when long-term toxicity testing on fish is to be carried out. The list of OECD test methods in point 9.1.6.1 should be replaced in order to take into account on-going developments as regards the information requirements on long-term toxicity studies on fish. |
(16) |
Several information requirements for microorganisms included in Title 2 of Annexes II and III to Regulation (EU) No 528/2012 are either overlapping with other provisions in the Annexes or are irrelevant for microorganisms. Title 2 of Annexes II and III to Regulation (EU) No 528/2012 should therefore be amended in order to eliminate such overlaps and irrelevant information requirements. |
(17) |
The fourth paragraph of point 2 of the introductory part of Annex III to Regulation (EU) No 528/2012 provides that for non-active substances, the applicants are to use the information provided to them in the context of Title IV of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (5). That paragraph should be amended in order to clarify that applicants may need to provide additional information on substances of concern included in biocidal products in particular in order to submit a data set that enables the identification of their endocrine disrupting properties. |
(18) |
In order to avoid imposing a disproportionate burden on economic operators, certain tests required by Annex II or Annex III to Regulation (EU) No 528/2012 that were already initiated or carried out before the date of application of this Regulation should be considered appropriate to address the information requirements. |
(19) |
A reasonable period should be allowed to elapse before the data requirements, as modified by this Delegated Regulation become applicable so that the applicants can make the necessary arrangements to meet those requirements. However, in the interests of the protection of human and animal health and of the environment, the applicants should be allowed to apply the changes introduced by this Regulation before its date of application on a voluntary basis. |
(20) |
Regulation (EU) No 528/2012 should therefore be amended accordingly, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EU) No 528/2012 is amended in accordance with Annex I to this Regulation.
Annex III to Regulation (EU) No 528/2012 is amended in accordance with Annex II to this Regulation.
Article 2
Notwithstanding the date of application of this Regulation laid down in Article 3, applications for approval of an active substance and applications for authorisation of a biocidal product submitted before 15 April 2022 shall be evaluated based on information requirements applicable on the day of submission of such applications.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 15 April 2022.
By way of derogation, applicants may choose to apply the data requirements as set out in the Annexes I and II to this Regulation from 15 April 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 October 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).
(3) Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).
(4) Scientific Opinion on the clarification of some aspects related to genotoxicity assessment. EFSA Journal 2017;15(12):5113, 25 pp.https://doi. org/10.2903/j.efsa.2017.5113
(5) Regulation (EC) No 1907/2006 of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), stablishing 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 (OJ L 396, 30.12.2006, p. 1).
ANNEX I
Annex II to Regulation (EU) No 528/2012 is amended as follows:
(1) |
the introductory part is amended as follows:
|
(2) |
the table in Title 1 is amended as follows:
|
(3) |
the table in Title 2 is amended as follows:
|
(*1) Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).’;’
ANNEX II
Annex III to Regulation (EU) No 528/2012 is amended as follows:
(1) |
the introductory part is amended as follows:
|
(2) |
the table in Title 1 is amended as follows:
|
(3) |
the table in Title 2 is amended as follows:
|
(*1) Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).’;’