Date: 2018-12-14Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2018/1980 of 13 December 2018 amending Implementing Regulation (EU) 2017/2325 as regards the terms of authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species (Text with EEA relevance.)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Regulation (EU) 2018/1980 amends Implementing Regulation (EU) 2017/2325 regarding the authorization terms for lecithins (liquid, hydrolysed, and deoiled) as feed additives for all animal species. It aligns specifications for lecithins as feed additives with those for food additives and extends authorization to include rapeseed as a source. The regulation includes transitional measures for products produced and labelled before specific dates in 2019, 2020 and 2021.
Key Points / Main Content:
* **Authorization Modification:**
* The regulation modifies the terms of authorization for lecithins (1c322i, 1c322ii, and 1c322iii) as feed additives.
* Specifications for lecithins as feed additives are aligned with specifications for lecithins as food additives.
* The authorization is extended to include rapeseed as an additional source of lecithins hydrolysed and lecithins deoiled.
* **Specifications and Characteristics:**
* Lecithins can be derived from soybean, sunflower, or rapeseed.
* Minimum content of substances insoluble in acetone is specified (not less than 60.0% for lecithins and deoiled lecithins; not less than 56.0% for hydrolysed lecithins and deoiled hydrolysed lecithins).
* Maximum limits are set for loss on drying, toluene-insoluble matter, acid value, and peroxide value.
* **Transitional Measures:**
* Additives and premixtures produced and labelled before 2 July 2019 under previous rules can be placed on the market and used until existing stocks are exhausted.
* Compound feed and feed materials for food-producing animals, containing the additives and produced/labelled before 2 January 2020 under previous rules, can be placed on the market and used until existing stocks are exhausted.
* Compound feed and feed materials for non-food-producing animals, containing the additives and produced/labelled before 2 January 2021 under previous rules, can be placed on the market and used until existing stocks are exhausted.
* **Effective Date:**
* The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
* **Feed Additive Manufacturers/Producers:**
* Impact: Must comply with the revised specifications for lecithins, including the allowance for rapeseed as a source. Need to update labels and production processes.
* Action Required: Adapt production processes and labeling to reflect the new specifications. Track production and labeling dates to adhere to transitional measures.
* **Feed Businesses/Distributors:**
* Impact: Need to be aware of the updated regulations for lecithins in feed. Need to manage existing stock produced under the old regulations according to the transitional measures.
* Action Required: Ensure that all products meet the new standards. Manage inventory to comply with transitional measures regarding products produced/labelled before the specified dates.
* **Animal Feed Users (Farmers, etc.):**
* Impact: May see changes in feed composition and labeling. Need to be aware of the regulation if they produce their own feed.
* Action Required: Be aware of changes in feed composition and labeling.
* **Enforcement Authorities:**
* Impact: Responsible for monitoring and enforcing compliance with the amended regulation.
* Action Required: Update monitoring procedures and ensure compliance with the new regulation.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
Treaty on the Functioning of the European Union: One of the primary treaties forming the constitutional basis of the European Union.
Regulation (EC) No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice on food safety.
Commission Implementing Regulation (EU) 2017/2325: A Commission Implementing Regulation concerning the authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins deoiled as feed additives for all animal species
Standing Committee on Plants, Animals, Food and Feed: A committee that provides opinions on measures related to food and feed safety.
Brussels: The location where the regulation was adopted.
L 317/12 EN Official Journal of the European Union 14.12.2018
COMMISSION IMPLEMENTING REGULATION (EU) 2018/1980
of 13 December 2018
amending Implementing Regulation (EU) 2017/2325 as regards the terms of authorisation
of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for
all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003
on additives for use in animal nutrition (1), and in particular Article 13(3) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation.
(2) The uses of the preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives were
authorised as feed additives for all animal species by Commission Implementing Regulation (EU) 2017/2325 (2).
(3) In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the applicant proposed changing the terms
of authorisation of the preparations by submitting an application to align the specifications of lecithins as feed
additives to the specifications set for lecithins when used as food additives and to extend the authorisation to the
use of rapeseed as an additional source of lecithins hydrolysed and lecithins de-oiled. The application was
accompanied by the relevant supporting data. The Commission forwarded the application to the European Food
Safety Authority (hereinafter ‘the Authority’).
(4) The Authority concluded in its opinion of 12 June 2018 (3) that all the lecithins of different botanical origin and
their forms used as feed additive meet the specifications set for the use of lecithins as food additive and that the
use of rapeseed as an additional source of lecithins does not modify the previous conclusions that the lecithins
do not have an adverse effect on animal health, human health or the environment and that they are efficacious as
emulsifier. The Authority does not consider that there is a need for specific requirements of post-market
monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the
Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of the proposed modifications to the authorisation shows that the conditions for authorisation,
as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
(6) Implementing Regulation (EU) 2017/2325 should therefore be amended accordingly.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Implementing Regulation (EU) 2017/2325 is replaced by the Annex to this Regulation.
Article 2
Transitional measures
1. The additives 1c322i, 1c322ii and 1c322iii and premixtures containing those additives which are produced and
labelled before 2 July 2019 in accordance with the rules applicable before 2 January 2019 may continue to be placed on
the market and used until the existing stocks are exhausted.
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Implementing Regulation (EU) 2017/2325 of 14 December 2017 concerning the authorisation of preparations of lecithins
liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species and amending Implementing Regulation (EU)
2017/1007 (OJ L 333, 15.12.2017, p. 17).
(3) EFSA Journal 2018; 16(6):5334.14.12.2018 EN Official Journal of the European Union L 317/13
2. Compound feed and feed materials containing the additives as specified in Annex I which are produced and
labelled before 2 January 2020 in accordance with the rules applicable before 2 January 2019 may continue to be
placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Compound feed and feed materials containing the additives as specified in Annex I which are produced and
labelled before 2 January 2021 in accordance with the rules applicable before 2 January 2019 may continue to be
placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing
animals.
Article 3
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, 13 December 2018.
For the Commission
The President
Jean-Claude JUNCKERANNEX
‘ANNEX I
Minimum Maximum
Identifica content content
Name of the Species or End of period
tion Composition, chemical formula, description, Maximum
holder of Additive category of Other provisions of authori
number of analytical method age mg of lecithins/kg of
authorisation animal sation
the additive complete feedingstuff with
a moisture content of 12 %
Category of technological additives. Functional group: emulsifiers
1c322i — Lecithins Additive composition All animal — — — In the label of feed additive 6 July 2027
species and premixures the form(s)
Preparations of: used shall be indicated
— lecithins and hydrolysed lecithins in liquid
(plastic to fluid) form;
— de-oiled lecithins and de-oiled hydrolysed
lecithins in solid form.
Characterisation of the active substance
Lecithins, hydrolysed lecithins, de-oiled le
cithins and de-oiled hydrolysed lecithins de
rived from soybean, sunflower or rapeseed:
CAS no. 8002-43-5;
Assay:
— Lecithins, de-oiled lecithins: not less than
60,0 % of substances insoluble in acetone;
— hydrolysed lecithins and de-oiled hydro
lysed lecithins: not less than 56,0 % sub
stances insoluble in acetone.
Loss on drying: not more than 2 % (105 °C,
1 hour)
Toluene-insoluble matter: not more than
0,3 %
L
317/14
EN
Official
Journal
of
the
European
Union
14.12.2018Minimum Maximum
Identifica content content
Name of the Species or End of period
tion Composition, chemical formula, description, Maximum
holder of Additive category of Other provisions of authori
number of analytical method age mg of lecithins/kg of
authorisation animal sation
the additive complete feedingstuff with
a moisture content of 12 %
Acid value:
— Lecithins, de-oiled lecithins not more than
35 mg of potassium hydroxide per gram;
— hydrolysed lecithins and de-oiled hydro
lysed lecithins: not more than 45 mg of
potassium hydroxide per gram
Peroxide value: equal to or less than 10
Analytical method(1)
For the characterisation of feed additive:
Commission Regulation (EU) No 231/2012(2)
and the corresponding tests in the FAO JECFA
monograph ‘Lecithin’(3)(4)
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
(2) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of
the Council (OJ L 83, 22.3.2012, p. 1).
(3) FAO JECFA Combined Compendium of Food Additive Specifications, ‘Lecithin’, Monograph No 4 (2007), http://www.fao.org/fileadmin/user_upload/jecfa_additives/docs/monograph4/additive-250-m4.pdf
(4) FAO JECFA Combined Compendium for Food Additive Specifications — Analytical methods, test procedures and laboratory solutions used by and referenced in the food additive specifications, Vol. 4,
http://www.fao.org/docrep/009/a0691e/a0691e00.htm’
14.12.2018
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317/15