Date: 2022-06-24Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2022/986 of 23 June 2022 not approving N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine as an existing active substance for use in biocidal products of product-type 8 (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision (EU) 2022/986, dated June 23, 2022, announces the non-approval of N3-aminopropyl-N-dodecylpropane-1,3-diamine as an existing active substance for use in biocidal products of product-type 8 (wood preservatives). The decision is based on identified unacceptable risks to human health and the lack of suitable risk mitigation measures. It enters into force twenty days after its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Substance Non-Approval:**
* N3-aminopropyl-N-dodecylpropane-1,3-diamine (EC No: 219-145-8; CAS No: 23728-29) is not approved for use in biocidal products of product-type 8.
* **Basis for Decision:**
* The decision follows the evaluation of the substance according to Directive 98/8/EC and Regulation (EU) No 528/2012.
* The Biocidal Products Committee issued an opinion on December 2, 2020, concluding that products containing the substance may not meet the criteria for approval due to unacceptable risks to human health.
* Realistic worst-case conditions and enforcement difficulties of risk mitigation measures were considered.
* **Entry into Force:**
* The decision takes effect on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
Stakeholders Impacted:
**Manufacturers and Suppliers of Biocidal Products Containing N3-aminopropyl-N-dodecylpropane-1,3-diamine:**
* Impact: Cannot use N3-aminopropyl-N-dodecylpropane-1,3-diamine in product-type 8 biocidal products.
* Action Required: Reformulate products to use alternative approved substances for wood preservation.
**Member States:**
* Impact: Required to enforce the decision and ensure that product-type 8 biocidal products containing N3-aminopropyl-N-dodecylpropane-1,3-diamine are not placed on the market or used.
* Action Required: Update national regulations and inform relevant stakeholders about the non-approval.
**Users of Product-Type 8 Biocidal Products:**
* Impact: May need to switch to alternative wood preservative products.
* Action Required: Identify and use approved alternative products for wood preservation.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
Regulation EU No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
Directive 98/8/EC: A directive of the European Parliament and of the Council concerning the placing of biocidal products on the market.
N3aminopropylNdodecylpropane1,3diamine: An existing active substance evaluated for its possible approval for use in biocidal products, specifically product type 8 (wood preservatives).
European Chemicals Agency: An agency of the European Union that implements EU legislation on chemicals.
Biocidal Products Committee: A committee that prepares the opinion of the Agency regarding the applications for approval of active substances.
Portugal: A Member State of the European Union, designated as the rapporteur Member State for the evaluation of N3aminopropylNdodecylpropane1,3diamine.
24.6.2022 EN Official Journal of the European Union L 167/111
COMMISSION IMPLEMENTING DECISION (EU) 2022/986
of 23 June 2022
not approving N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine as an existing active substance for
use in biocidal products of product-type 8
(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 89(1), third subparagraph,
thereof,
Whereas:
(1) Commission Delegated Regulation (EU) No 1062/2014(2) establishes a list of existing active substances to be
evaluated for their possible approval for use in biocidal products. That lists includes N-(3-aminopropyl)-N-
dodecylpropane-1,3-diamine (EC No: 219-145-8; CAS No: 2372-82-9).
(2) N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine has been evaluated for use in biocidal products of product-type
8, wood preservatives, as described in Annex V to Directive 98/8/EC of the European Parliament and of the
Council(3), which corresponds to product-type 8 as described in Annex V to Regulation (EU) No 528/2012.
(3) Portugal was designated as the rapporteur Member State and its evaluating competent authority submitted the
assessment report together with its conclusions to the Commission on 9 November 2005. After the submission of
the assessment report, discussions took place in technical meetings organised by the Commission and, after
1 September 2013, by the European Chemicals Agency (‘the Agency’).
(4) It can be derived from Article 90(2) of Regulation (EU) No 528/2012 that substances for which the Member States’
evaluation has been completed by 1 September 2013 should be evaluated in accordance with the provisions of
Directive 98/8/EC.
(5) In accordance with Article 75(1) of Regulation (EU) No 528/2012, the Biocidal Products Committee prepares the
opinion of the Agency regarding the applications for approval of active substances. In accordance with Article 7(2)
of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinion of the Agency
on 2 December 2020(4), having regard to the conclusions of the evaluating competent authority.
(6) It can be derived from that opinion that biocidal products of product-type 8 containing N-(3-aminopropyl)-N-
dodecylpropane-1,3-diamine may not be expected to meet the criteria laid down in Article 5(1), point (b) of
Directive 98/8/EC which correspond to the criteria laid down in provisions Article 19(1), point (b), of Regulation
(EU) No 528/2012 as unacceptable risks for human health have been identified, and no suitable risk mitigation
measure could be identified.
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of
all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament
and of the Council (OJ L 294, 10.10.2014, p. 1).
(3) 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).
(4) Biocidal Products Committee Opinion on the application for approval of the active substance: N-(3-aminopropyl)-N-dodecylpropa
ne-1,3-diamine, Product type: 8, ECHA/BPC/270/2020, adopted on 2 December 2020.L 167/112 EN Official Journal of the European Union 24.6.2022
(7) In the discussions with the representatives of the Member States within the Standing Committee on Biocidal
Products, it was considered that the evaluation was made according to realistic worst case conditions, and that
limiting the number of cycles of treatment of wood to two per day per operator would not be a suitable risk
mitigation measure to reduce the identified risks to human health to an acceptable level, due to difficulties of
enforcement and control.
(8) Taking into account the opinion of the Agency and the discussions in the Standing Committee on Biocidal Products,
it is not appropriate to approve N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine for use in biocidal products of
product-type 8.
(9) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine (EC No: 219-145-8; CAS No: 2372-82-9) is not approved as an active
substance for use in biocidal products of product-type 8.
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, 23 June 2022.
For the Commission
The President
Ursula VON DER LEYEN