Date: 2022-10-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2022/1990 of 20 October 2022 cancelling the approval of tolylfluanid as an active substance for use in biocidal products of product-type 7 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2022/1990 cancels the approval of tolylfluanid as an active substance for use in biocidal products of product type 7 due to safety concerns. The regulation repeals Implementing Regulation (EU) 2016/1087. Treated articles containing tolylfluanid for product type 7 cannot be placed on the Union market after May 10, 2023. The regulation is effective from the twentieth day following its publication.
Key Points / Main Content:
* **Cancellation of Approval:** Tolylfluanid's approval as an active substance for biocidal products of product type 7 is cancelled.
* **Review Basis:**
* Denmark requested a review due to the presence of dimethylsulfamid, a tolylfluanid metabolite, in drinking water.
* The initial applicant stopped production and placing on the market of biocidal products containing tolylfluanid and will not seek renewal of approval.
* There are no other suppliers of the substance and no biocidal product containing tolylfluanid for product type 7 is authorised in the Union.
* **Repeal of Existing Regulation:** Implementing Regulation (EU) 2016/1087, which previously approved tolylfluanid, is repealed effective November 10, 2022.
* **Restrictions on Treated Articles:** Treated articles incorporating tolylfluanid for product type 7 cannot be placed on the Union market after May 10, 2023.
* **Entry into Force:** The regulation came into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
* **Economic Operators:**
* *Impact:* Economic operators are affected by the cancellation of tolylfluanid's approval and the restriction on placing treated articles containing it on the market.
* *Action Required:* Operators must adapt to the ban and cease placing treated articles treated with or incorporating tolylfluanid on the Union market by May 10, 2023.
* **European Commission:**
* *Impact:* The Commission is responsible for implementing and enforcing the regulation.
* *Action Required:* The Commission has repealed Implementing Regulation (EU) 2016/1087 and will oversee compliance with the new restrictions.
* **Member States:**
* *Impact:* Member states are obligated to apply the regulation within their jurisdictions.
* *Action Required:* Member states must ensure the regulation is enforced and that relevant parties are aware of the changes.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Commission Implementing Regulation (EU) 2022/1990: The specific regulation cancelling the approval of tolylfluanid as an active substance for use in biocidal products of product type 7.
Tolylfluanid: An active substance used in biocidal products, specifically product type 7 (film preservatives), whose approval is being cancelled.
Regulation (EU) No 528/2012: Regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
Denmark: A country within the European Union that requested a review of the approval of tolylfluanid.
European Chemicals Agency: An agency of the European Union that works to protect human health and the environment from the risks posed by chemicals.
Ursula VON DER LEYEN: The President of the European Commission, who signed the regulation.
Brussels: The location where the regulation was adopted.
21.10.2022 EN Official Journal of the European Union L 273/9
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1990
of 20 October 2022
cancelling the approval of tolylfluanid as an active substance for use in biocidal products of product-
type 7 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the
Council
(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 2012concerning
the making available on the market and use of biocidal products(1), and in particular Article 15(1) thereof,
Whereas:
(1) Tolylfluanid was approved as an active substance for use in biocidal products of product-type 7, film preservatives,
as described in Annex V to Regulation (EU) No 528/2012, by Commission Implementing Regulation (EU)
2016/1087(2), subject to compliance with certain conditions (‘the approval’).
(2) On 2 March 2020, Denmark requested that the Commission should initiate a review of the approval pursuant to
Article 15(1) of Regulation (EU) No 528/2012, on the basis of significant indications that the use of the active
substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal
products or treated articles. In more detail, a metabolite of tolylfluanid, dimethylsulfamid, has been found in a great
number of Danish drinking water supplies, and these contaminations can be linked with use of paints treated with
tolylfluanid. Where groundwater is ozonated in water treatment for the production of drinking water,
dimethylsulfamid may turn into N-nitrosodimethylamine which is genotoxic, mutagenic and carcinogenic.
Denmark therefore requested a revision of the evaluation of the groundwater risk assessment for tolylfluanid for
product-type 7, with the view to restrict the use of tolylfluanid in outdoor paints treated with tolylfluanid.
(3) On 5 July 2021, the Commission announced to the initial applicant for approval of tolylfluanid its intention to start
the procedure for the review of the approval of that active substance for product-type 7 in accordance with Article
15(1) of Regulation (EU) No 528/2012, and provided an opportunity for the initial applicant to submit comments.
Moreover, the Commission made publicly available the information that it is carrying out this review on the website
of the Directorate-General for Health and Food Safety in accordance with Article 15(1) of Regulation (EU)
No 528/2012.
(4) On 7 October 2021, the initial applicant for the approval of tolylfluanid indicated that it stopped the production of
the active substance and the placing on the market of biocidal products containing it, and will not seek the renewal
of approval of the substance. The initial applicant for the approval of tolylfluanid is the only substance supplier
within the meaning of Article 95(1), first subparagraph, of Regulation (EU) No 528/2012 included in the list
referred to in that subparagraph, for that active substance and product-type, published on the European Chemicals
Agency’s website. Furthermore, no biocidal product containing tolylfluanid for product-type 7 is authorised in the
Union.
(5) Given that there are no other suppliers of the substance, that no biocidal product containing tolylfluanid for
product-type 7 is authorised in the Union and that the initial applicant will not seek the renewal of approval of the
substance, the Commission did not consult the European Chemicals Agency pursuant to Article 15(2) of Regulation
(EU) No 528/2012.
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Implementing Regulation (EU) 2016/1087 of 5 July 2016 approving tolylfluanid as an existing active substance for use in
biocidal products of product-type 7 (OJ L 180, 6.7.2016, p. 18).L 273/10 EN Official Journal of the European Union 21.10.2022
(6) After having reviewed the information provided, the Commission considers that the use of tolylfluanid in biocidal
products and treated articles raises significant concerns about the safety of such biocidal products and treated
articles. Given the fact that there are no other suppliers of the substance, that no biocidal product containing
tolylfluanid for product-type 7 is authorised in the Union and that the initial applicant will not seek the renewal of
approval of the substance, the Commission considers appropriate to cancel the approval of tolylfluanid as an active
substance for use in biocidal products of product-type 7.
(7) Implementing Regulation (EU) 2016/1087 should therefore be repealed.
(8) As economic operators need time to adapt to the cancellation of the approval, it should be allowed to continue
placing on the Union market treated articles treated with or incorporating tolylfluanid for product-type 7 for some
time.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
The approval of tolylfluanid as an active substance for use in biocidal products of product-type 7 is cancelled.
Article 2
Implementing Regulation (EU) 2016/1087 is repealed with effect from 10 November 2022.
Article 3
Treated articles treated with or incorporating tolylfluanid for product-type 7 shall not be placed on the Union market from
10 May 2023.
Article 4
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, 20 October 2022.
For the Commission
The President
Ursula VON DER LEYEN