Date: 2021-03-09Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Delegated Regulation (EU) 2021/407 of 3 November 2020 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include citric acid as an active substance in Annex I thereto (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Delegated Regulation (EU) 2021/407 amends Regulation (EU) No 528/2012 to include citric acid in Annex I, category 6, as an approved active substance for biocidal products. This inclusion is based on the European Chemicals Agency's opinion that citric acid does not raise concerns and meets the necessary requirements. The regulation came into force twenty days after its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Inclusion of Citric Acid in Annex I:**
* Citric acid is added to Annex I of Regulation (EU) No 528/2012, specifically in Category 6 of the list of active substances.
* The EC number for citric acid is 201-069-1, and the CAS No is 77-92-9.
* **Purity Requirements:**
* The minimum degree of purity for citric acid as an active substance is 995 g/kg.
* 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.
* **Basis for Inclusion:**
* The inclusion is based on the assessment of citric acid as an existing active substance within the review programme.
* The European Chemicals Agency's Biocidal Products Committee issued a favorable opinion on citric acid on 16 February 2016.
* **Effective Date:**
* The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
European Commission:
* Impact: The Commission has formally adopted and published the regulation, amending existing biocidal product regulations.
* Action Required: Ensure the regulation is properly implemented and enforced across member states.
Member States:
* Impact: Member states must recognize citric acid as an approved active substance for use in biocidal products.
* Action Required: Update national regulations and procedures to reflect the inclusion of citric acid in Annex I of Regulation (EU) No 528/2012.
Biocidal Product Manufacturers and Suppliers:
* Impact: Manufacturers and suppliers can now use citric acid in biocidal products, provided it meets the specified purity requirements.
* Action Required: Ensure that citric acid used in products meets the minimum purity standards or is proven technically equivalent if of different purity. Update product information and labeling accordingly.
European Chemicals Agency (ECHA):
* Impact: ECHA's opinion supported the inclusion of citric acid.
* Action Required: Continue to provide guidance and support to member states and industry regarding the implementation of the regulation.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution 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 regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
European Parliament: The directly elected parliamentary body of the European Union.
European Chemicals Agency: An agency of the European Union which manages the technical, scientific and administrative aspects of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Biocidal Products Regulation (BPR).
Citric acid: An organic acid, found in many fruits and vegetables, that is being assessed as an active substance within the review programme set out in Article 89(1) of Regulation (EU) No 528/2012.
Brussels: The capital of Belgium and a major centre for European politics, where the regulation was adopted.
Ursula VON DER LEYEN: The President of the European Commission.
9.3.2021 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 81/15
COMMISSION DELEGATED REGULATION (EU) 2021/407
of 3 November 2020
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include
citric acid as an active substance in Annex I thereto
(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 28(1) thereof,
Whereas:
(1) Citric acid has been assessed as an existing active substance within the review programme set out in Article 89(1) of
Regulation (EU) No 528/2012 established by Commission Delegated Regulation (EU) No 1062/2014(2).
(2) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals
Agency (‘the Agency’) was adopted on 16 February 2016 by the Biocidal Products Committee(3), having regard to
the conclusions of the evaluating competent authority. That opinion concluded that biocidal products of product-
type 2 containing citric acid may be expected to fulfill the requirements of Article 5 of Directive 98/8/EC of the
European Parliament and of the Council(4) which were the requirements applicable to the examination of the
application for approval of citric acid in accordance with Article 90(2) of Regulation (EU) No 528/2012.
(3) Citric acid was therefore approved as an active substance for use in biocidal products of product-type 2 by
Commission Implementing Regulation (EU) 2016/1938(5).
(4) The opinion of the Agency also concluded that citric acid does not give rise to concern and is eligible for inclusion in
Annex I to Regulation (EU) No 528/2012.
(5) Taking into account the opinion of the Agency, it is therefore appropriate to include citric acid in Annex I to
Regulation (EU) No 528/2012. As citric acid has been assessed based on an active substance dossier satisfying the
requirements laid down in Article 11(1) of Directive 98/8/EC, citric acid should be included in category 6 of Annex
I to that Regulation,
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Regulation (EU) No 528/2012 is amended in accordance with the Annex to this Regulation.
(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) Biocidal Products Committee Opinion on the application for approval of the active substance: Citric acid, Product type: 2, ECHA/BPC/
088/2016, adopted on 16 February 2016.
(4) 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).
(5) Commission Implementing Regulation (EU) 2016/1938 of 4 November 2016 approving citric acid as an existing active substance for
use in biocidal products of product-type 2 (OJ L 299, 5.11.2016, p. 54).L 81/16 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 9.3.2021
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, 3 November 2020.
For the Commission
The President
Ursula VON DER LEYEN9.3.2021 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 81/17
ANNEX
In Annex I to Regulation (EU) No 528/2012, in Category 6 of the List of active substances referred to in Article 25(a), the
following entry is added:
EC number Name/group Restriction Comment
‘201-069-1 Citric acid Minimum degree of purity of the active CAS No 77-92-9
substance (*): 995 g/kg
_____________
(*) 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
activesubstance.’.