Date: 13-May-2024Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2024/1278 of 8 May 2024 postponing the expiry date of the approval of hydrogen cyanide for use in biocidal products of product-types 8, 14 and 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Issued by European Commission
· Directorate-General for Health and Food Safety
This Commission Implementing Decision (EU) 2024/1278 postpones the expiry date of the approval of hydrogen cyanide for use in biocidal products of product-types 8, 14, and 18.
Key Changes
The expiry date for the approval of hydrogen cyanide for use in biocidal products of product-types 8, 14, and 18, initially set to expire on 30 September 2024, is now postponed to 31 March 2027.
This postponement is due to the ongoing evaluation of applications for the renewal of the approval, which requires a full evaluation by the evaluating competent authority of Czech Republic, preparation of an opinion by the European Chemicals Agency (ECHA), and a final decision by the Commission.
Impact Analysis
Biocidal Product Manufacturers/Suppliers
Action Item: Monitor the progress of the renewal applications and prepare for potential changes in regulations or conditions of use following the Commission's decision.
Users of Biocidal Products
Action Item: Stay informed about any updates or changes to the permitted uses or safety measures associated with these products.
Czech Republic (Evaluating Competent Authority)
Action Item: Prioritize the evaluation of the applications and communicate any data requests or findings to the applicants and the European Chemicals Agency (ECHA) in a timely manner.
European Chemicals Agency (ECHA)
Action Item: Prepare the opinion within 270 days of receiving the recommendation from the Czech Republic and submit it to the Commission.
European Commission
Action Item: Consider the opinion from ECHA and make a decision on the renewal of the approval before 31 March 2027.
Key Entities Referenced
European Commission: The executive branch of the European Union, responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
European Parliament: The directly elected parliamentary institution of the European Union.
Council of the European Union: One of the legislative bodies of the European Union, composed of government ministers from each member state.
Regulation (EU) No 528/2012: Regulation concerning the making available on the market and use of biocidal products.
Directive 98/8/EC: Directive of the European Parliament and of the Council concerning the placing of biocidal products on the market.
European Chemicals Agency (ECHA): An agency of the European Union which manages the technical, scientific and administrative aspects of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.
Czech Republic (Evaluating Competent Authority): The designated authority in the Czech Republic responsible for evaluating the applications for renewal of the approval of hydrogen cyanide.
Official Journal EN
of the European Union L series
2024/1278 13.5.2024
COMMISSION IMPLEMENTING DECISION (EU) 2024/1278
of 8 May 2024
postponing the expiry date of the approval of hydrogen cyanide for use in biocidal products of
product-types 8, 14 and 18 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 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Hydrogen cyanide was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council(2)as
an active substance for use in biocidal products of product-types 8, 14 and 18. Pursuant to Article 86 of Regulation
(EU) No 528/2012, it is therefore considered approved under that Regulation subject to the conditions set out in
Annex I to Directive 98/8/EC.
(2) The approval of hydrogen cyanide for use in biocidal products of product-types 8, 14 and 18 (‘the approval’) is to
expire on 30 September 2024. On 29 March 2023, an application was submitted in accordance with Article 13(1)
of Regulation (EU) No 528/2012 for the renewal of the approval of hydrogen cyanide for use in biocidal products
of product-type 8, and on 30 March 2023, applications were submitted for the renewal of the approval of hydrogen
cyanide for use in biocidal products of product-types 14 and 18 (‘the applications’).
(3) On 8 December 2023, the evaluating competent authority of Czech Republic informed the Commission that it had
decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the applications was
necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full
evaluation of the application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out
the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is
suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of
the data requested or by exceptional circumstances.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p.1, ELI: http://data.europa.eu/eli/dir/1998/8).
ELI: http://data.europa.eu/eli/dec_impl/2024/1278/oj 1/2EN
OJ L, 13.5.2024
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals
Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the
active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has
been taken on its renewal. It is therefore appropriate to postpone the expiry date of the approval for a period of
time sufficient to finalise the examination of the applications. Taking into account the time-limits for evaluation by
the evaluating competent authority, for preparation and submission by the Agency of its opinions and the time
needed for the Commission to decide whether to renew the approval of hydrogen cyanide for use in biocidal
products of product-types 8, 14 and 18, the expiry date should be postponed to 31 March 2027.
(7) After the postponement of the expiry date of the approval, hydrogen cyanide remains approved for use in biocidal
products of product-types 8, 14 and 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of hydrogen cyanide for use in biocidal products of product-types 8, 14 and 18 set out in
Annex I to Directive 98/8/EC is postponed to 31 March 2027.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
Done at Brussels, 8 May 2024.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/dec_impl/2024/1278/oj