Date: 2022-10-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2022/1993 of 20 October 2022 approving Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide as an active substance for use in biocidal products of product-type 19 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:
This regulation approves Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide as an active substance for use in biocidal products of product type 19. The approval is subject to specific conditions outlined in the annex. The regulation entered into force on November 9, 2022. The expiry date of approval is January 31, 2034.
Key Points / Main Content:
* **Approval:**
* Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide is approved for use in biocidal products of product type 19 (repellents and attractants).
* **Conditions:**
* Minimum degree of purity of the active substance: 100% (ww).
* The product assessment shall pay particular attention to the exposures, risks, and efficacy linked to any uses covered by an application for authorization, but not addressed in the Union-level risk assessment of the active substance.
* The product assessment shall pay particular attention to the exposure of, and potential risks for, non-professional users and the general public.
* For products that may lead to residues in food or feed, verify the need to set new or amend existing maximum residue levels (MRLs) and take appropriate risk mitigation measures to ensure MRLs are not exceeded.
* **Dates:**
* Date of approval: 1 February 2024.
* Expiry date of approval: 31 January 2034.
* **Identification Numbers:**
* EC No: 289-699-3
* CAS No: 89997-63-7
Impact Analysis:
Biocidal Product Manufacturers:
* Impact: Can use Chrysanthemum cinerariaefolium extract in product type 19 biocidal products, subject to the specified conditions.
* Action Required: Ensure products meet the purity standards, conduct thorough risk assessments as specified, and verify MRLs if the product may lead to residues in food or feed.
Member States:
* Impact: Must ensure that biocidal products containing the approved active substance comply with the conditions outlined in the regulation.
* Action Required: Enforce the regulation and monitor compliance.
European Chemicals Agency (ECHA):
* Impact: Plays a role in assessing applications for approval of active substances and preparing opinions.
* Action Required: Continue to assess and provide opinions on active substances.
Non-professional users and the general public:
* Impact: Exposure to biocidal products containing Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide.
* Action Required: Follow instructions of the biocidal products.
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, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EU No 528/2012: A European Union regulation concerning the making available on the market and use of biocidal products.
European Parliament: The directly elected parliamentary institution of the European Union.
Council of the European Union: Also known as the Council, it is a component of the EU's legislative branch where ministers from each national government meet to adopt laws and coordinate policies.
Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide: An active substance approved for use in biocidal products of product-type 19.
Biocidal Products Committee: A committee that prepares the opinion of the Agency regarding the applications for approval of active substances.
European Chemicals Agency: An agency of the European Union that implements EU legislation on chemicals.
21.10.2022 EN Official Journal of the European Union L 273/17
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1993
of 20 October 2022
approving Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum
cinerariifolium obtained with supercritical carbon dioxide as an active substance for use in biocidal
products of product-type 19 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 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 list includes Chrysanthemum cinerariaefolium
extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide.
(2) Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with
supercritical carbon dioxide has been evaluated for use in biocidal products of product-type 19 (repellents and
attractants), as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council(3), which
correspond to product-type 19 as described in Annex V to Regulation (EU) No 528/2012.
(3) Spain was designated as the rapporteur Member State and its evaluating competent authority submitted the
assessment report together with its conclusions to the Commission on 1 September 2010. 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 follows 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 assessed 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(4)on 3 December 2021, having regard to the conclusions of the evaluating competent authority.
(6) According to that opinion, biocidal products of product-type 19 containing Chrysanthemum cinerariaefolium extract
from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide may be
expected to satisfy the requirements laid down in Article 5(1), points (b), (c) and (d) of Directive 98/8/EC, provided
that certain requirements concerning their use are complied with.
(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 Chrysanthemum cinerariaefolium, extract
from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide; Product-type 19; ECHA/BPC/
313/2021, adopted on 3 December 2021.L 273/18 EN Official Journal of the European Union 21.10.2022
(7) Taking into account the opinion of the Agency, it is appropriate to approve Chrysanthemum cinerariaefolium extract
from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide as an active
substance for use in biocidal products of product-type 19 subject to compliance with certain conditions.
(8) A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested
parties to take the preparatory measures necessary to meet the new requirements.
(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
Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical
carbon dioxide is approved as an active substance for use in biocidal products of product-type 19 subject to the conditions
set out in the Annex.
Article 2
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 LEYENANNEX
IUPAC Name
Minimum degree of purity Expiry date of Product
Common Name Date of approval Specific conditions
of the active substance(1) approval type
Identification Numbers
Chrysanthemum Chrysanthemum 100 % w/w of 1 February 2024 31 January 2034 19 The authorisation of biocidal products is subject to the
cinerariaefolium cinerariaefolium extract Chrysanthemum following conditions:
extract from from open and mature cinerariaefolium extract
supercritical carbon flowers of Tanacetum from open and mature (1) The product assessment shall pay particular attention to
dioxide cinerariifolium obtained flowers of Tanacetum the exposures, the risks and the efficacy linked to any
with supercritical carbon cinerariifolium obtained uses covered by an application for authorisation, but
dioxide with supercritical carbon not addressed in the Union-level risk assessment of the
dioxide active substance;
EC No: 289-699-3
(2) The product assessment shall pay particular attention to
CAS No: 89997-63-7 the exposure of and potential risks for non-professional
users and the general public;
(3) For products that may lead to residues in food or feed, the
need to set new or to amend existing maximum residue
levels (MRLs) in accordance with Regulation (EC)
No 470/2009 of the European Parliament and of the
Council(2)or Regulation (EC) No 396/2005 of the Euro
pean Parliament and of the Council(3)shall be verified,
and any appropriate risk mitigation measures shall be
taken to ensure that such MRLs are not exceeded.
(1) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has
been proven to be technically equivalent to the evaluated active substance.
(2) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009laying down Community procedures for the establishment of residue limits of pharmacologically active substances
in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the
European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
(3) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending
Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
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