Date: 2016-10-20Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Directive (EU) 2016/1855 of 19 October 2016 amending Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (Text with EEA relevance)
**Executive Summary:**
Commission Directive (EU) 2016/1855 amends Directive 2009/32/EC regarding extraction solvents in food production. It specifically addresses the use of dimethyl ether (DME) by modifying the maximum residual limits (MRLs) for DME in collagen, collagen derivatives, and gelatine. Member States must implement the necessary laws, regulations, and administrative provisions within two years of the directive's entry into force, and communicate these to the Commission. The Directive came into force on 9 November 2016.
**Key Points / Main Content:**
* **Amendment of Annex I to Directive 2009/32/EC:**
* The row for Dimethyl ether in Part II of Annex I to Directive 2009/32/EC is replaced as specified in the Annex to this Directive.
* **Dimethyl Ether (DME) Usage and MRLs:**
* DME is authorized for use in the preparation of defatted animal protein.
* MRL for DME in defatted animal protein products, including gelatine: 0.009 mg/kg.
* MRL for DME in collagen and collagen derivatives (excluding gelatine): 3 mg/kg.
* **Definitions:**
* Gelatine is defined as natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals, in accordance with Regulation EC No 853/2004.
* Collagen is defined as the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with Regulation EC No 853/2004.
* **Implementation by Member States:**
* Member States must enact the laws, regulations, and administrative provisions to comply with this Directive within two years of its entry into force.
* Member States shall communicate these provisions to the Commission.
* Member States shall communicate the main provisions of national law adopted in the covered field to the Commission.
* **Entry into Force:**
* The Directive entered into force on the twentieth day following its publication in the Official Journal of the European Union (9 November 2016).
**Impact Analysis:**
* **Member States:**
* *Impact:* Required to transpose the Directive into national law and enforce the updated regulations regarding the use of dimethyl ether as an extraction solvent.
* *Action Required:* Enact and communicate the necessary legal and administrative provisions to the Commission within two years of the Directive's entry into force.
* **Food Producers/Manufacturers:**
* *Impact:* Those using dimethyl ether as an extraction solvent in the production of foodstuffs and food ingredients, particularly collagen, collagen derivatives, and gelatine, must comply with the new MRLs.
* *Action Required:* Ensure production processes adhere to the updated MRLs for dimethyl ether and maintain appropriate documentation to demonstrate compliance.
* **European Commission:**
* *Impact:* Responsible for overseeing the implementation of the Directive by Member States and ensuring compliance with the updated regulations.
* *Action Required:* Monitor and assess the measures taken by Member States to comply with the Directive.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Parliament: One of the legislative bodies of the European Union.
Council of the European Union: A legislative body of the European Union, comprising ministers from member states.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
Directive 2009/32/EC: A directive of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients.
Akzo Nobel Industrial Chemicals BV: A company that submitted an application regarding the use of dimethyl ether as an extraction solvent.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communication on risks associated with the food chain.
Brussels: The de facto capital city of the European Union, located in Belgium; the location where the directive was adopted.
20.10.2016 EN Official Journal of the European Union L 284/19
DIRECTIVES
COMMISSION DIRECTIVE (EU) 2016/1855
of 19 October 2016
amending Directive 2009/32/EC of the European Parliament and of the Council on the
approximation of the laws of the Member States on extraction solvents used in the production of
foodstuffs and food ingredients
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approx
imation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food
ingredients (1), and in particular point (a) of the first subparagraph of Article 4 thereof,
Whereas:
(1) Directive 2009/32/EC applies to extraction solvents used or intended for use in the production of foodstuffs or
food ingredients. That Directive does not apply to extraction solvents used in the production of food additives,
vitamins and other nutritional additives, unless such food additives, vitamins or nutritional additives are listed in
its Annex I.
(2) On 19 August 2014, an application was submitted by Akzo Nobel Industrial Chemicals BV requesting a change
in the maximum residual limit (MRL) for dimethyl ether (DME) as an extraction solvent in defatted animal protein
products, in particular collagen and collagen derivatives, from 0,009 mg/kg to 3 mg/kg, and a new use for the
extraction of protein products to yield gelatine with a MRL of 0,009 mg/kg. That application was subsequently
made available to the Member States.
(3) The European Food Safety Authority (‘the Authority’) re-evaluated the safety of DME as an extraction solvent for
the preparation of defatted animal protein products — collagen and gelatine — and issued its opinion on 14 July
2015 (2). The Authority concluded that the use of DME as an extraction solvent, under the intended conditions
of use and with the proposed MRLs of 3 mg/kg in collagen and collagen derivatives and 0,009 mg/kg in gelatine,
is of no safety concern.
(4) Therefore, it is appropriate to authorise the use of dimethyl ether as an extraction solvent to remove fat from
animal protein raw materials under the condition of maximum residual limits of dimethyl ether of 3 mg/kg in
collagen and collagen derivatives and of 0,009 mg/kg in gelatine.
(5) Directive 2009/32/EC should therefore be amended accordingly.
(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex I to Directive 2009/32/EC is amended in accordance with the Annex to this Directive.
(1) OJ L 141, 6.6.2009, p. 3.
(2) EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2015. Scientific Opinion on the
safety of use of dimethyl ether as an extraction solvent under the intended conditions of use and the proposed maximum residual limits.
EFSA Journal 2015;13(7):4174, 13 pp.L 284/20 EN Official Journal of the European Union 20.10.2016
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with
this Directive not later than two years after the date of entry into force of this Directive. They shall forthwith
communicate to the Commission the text of those provisions.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such
a reference on the occasion of their official publication. Member States shall determine how such reference is to be
made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they
adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 19 October 2016.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX
In Part II of Annex I to Directive 2009/32/EC, the row for ‘Dimethyl ether’ is replaced by the following:
‘Dimethyl ether Preparation of defatted animal protein 0,009 mg/kg in the defatted animal protein
products including gelatine(*) products including gelatine
Preparation of collagen(**) and collagen 3 mg/kg in the collagen and collagen deriva
derivatives, except gelatine tives, except gelatine
(*) ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones,
hides and skins, tendons and sinews of animals, in accordance with the relevant requirements of Regulation (EC) No 853/2004.
(**) ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with
the relevant requirements of Regulation (EC) No 853/2004.’