
Article 1 
This Regulation provides a framework for the traceability of products consisting of or containing genetically modified organisms (GMOs), and food and feed produced from GMOs, with the objectives of facilitating accurate labelling, monitoring the effects on the environment and, where appropriate, on health, and the implementation of the appropriate risk management measures including, if necessary, withdrawal of products.
Article 2 

1. This Regulation shall apply, at all stages of the placing on the market, to:
(a) products consisting of, or containing, GMOs, placed on the market in accordance with   assimilated  law;
(b) food produced from GMOs, placed on the market in accordance with   assimilated  law;
(c) feed produced from GMOs, placed on the market in accordance with   assimilated  law.
2. This Regulation shall not apply to medicinal products  authorised under the Human Medicines Regulations 2012 or the Veterinary Medicines Regulations 2013.
Article 3 
For the purpose of this Regulation:

1.. ‘Genetically modified organism’ or ‘GMO’ means genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex IB to Directive 2001/18/EC;
2.. ‘Produced from GMOs’ means derived, in whole or in part, from GMOs, but not containing or consisting of GMOs;
3.. ‘Traceability’ means the ability to trace GMOs and products produced from GMOs at all stages of their placing on the market through the production and distribution chains;
4.. ‘Unique identifier’ means a simple numeric or alphanumeric code which serves to identify a GMO on the basis of the authorised transformation event from which it was developed and providing the means to retrieve specific information pertinent to that GMO;
5.. ‘Operator’ means a natural or legal person who places a product on the market or who receives a product that has been placed on the market in  Great Britain  at any stage of the production and distribution chain, but does not include the final consumer;
6.. ‘Final consumer’ means the ultimate consumer who will not use the product as part of any business operation or activity;
7.. ‘Food’ means food as defined in Article 2 of Regulation (EC) No 178/2002;
8.. ‘Ingredient’ means ingredient as referred to in  Article 2(2)(f) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council;
9.. ‘Feed’ means feed as defined in Article 3(4) of Regulation (EC) No 178/2002;
10.. “Placing on the market” means placing on the market as defined in the specific legislation under which the relevant product is authorised; in other cases, it means “marketed” within the meaning given in section 107(11) of the Environmental Protection Act 1990.
11.. ‘The first stage of the placing on the market of a product’ means the initial transaction in the production and distribution chains, where a product is made available to a third party;
12.. ‘Pre-packaged product’ means any single item offered for sale consisting of a product and the packaging into which it was put before being offered for sale, whether such packaging encloses the product completely or only partially, provided that the contents cannot be altered without opening or changing the packaging.
13.. “Competent authority” means—
(a) in England, the Secretary of State;
(b) in Wales, the Welsh Ministers;
(c) in Scotland, the Scottish Ministers;
14.. ‘Appropriate authority’ means—
(a) in relation to England, the Secretary of State;
(b) in relation to Wales, the Welsh Ministers;
(c) in relation to Scotland, the Scottish Ministers;but the appropriate authority is the Secretary of State if consent is given by—
(a) in relation to Wales, the Welsh Ministers;
(b) in relation to Scotland, the Scottish Ministers;
15.. ‘Relevant food standards authority’ means—
(a) in relation to England  and Wales, the Food Standards Agency;
(b) in relation to Scotland, Food Standards Scotland.
Article 4 
A. 
1. At the first stage of the placing on the market of a product consisting of or containing GMOs, including bulk quantities, operators shall ensure that the following information is transmitted in writing to the operator receiving the product:
(a) that it contains or consists of GMOs;
(b) the unique identifier(s) assigned to those GMOs ....
2. At all subsequent stages of the placing on the market of products referred to in paragraph 1, operators shall ensure that the information received in accordance with paragraph 1 is transmitted in writing to the operators receiving the products.
3. In the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed or for processing, the information referred to in paragraph 1(b) may be replaced by a declaration of use by the operator, accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the mixture.
4. Without prejudice to Article 6, operators shall have in place systems and standardised procedures to allow the holding of information specified in paragraphs (1), (2) and (3) and the identification, for a period of five years from each transaction, of the operator by whom and the operator to whom the products referred to in paragraph 1 have been made available.
5. Paragraphs 1 to 4 shall be without prejudice to other specific requirements in   assimilated law.
B. 
6. For products consisting of or containing GMOs, operators shall ensure that:
(a) for pre-packaged products consisting of, or containing GMOs, the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified [name of organism(s)]’ appear on a label;
(b) for non-pre-packaged products offered to the final consumer the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified [name of organism(s)]’ shall appear on, or in connection with, the display of the product.This paragraph shall be without prejudice to other specific requirements in   assimilated  law.
C. 
7. Paragraphs 1 to 6 shall not apply to traces of GMOs in products in a proportion no higher than the thresholds  referred to in, or, where relevant, the thresholds established or amended under, Article 4A of this Regulation, provided that these traces of GMOs are adventitious or technically unavoidable.
8. Paragraphs 1 to 6 shall not apply to traces of GMOs in products intended for direct use as food, feed or for processing in a proportion no higher than the thresholds established for those GMOs in accordance with Articles 12 or 24  of Regulation (EC) No 1829/2003, provided that these traces of GMOs are adventitious or technically unavoidable.
Article 4A 

(1.) In relation to the thresholds provided for in Article 21 of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC or established by virtue of any other relevant  assimilated  law, an appropriate authority may, by regulations, make provision establishing or amending, where relevant, thresholds mentioned in or established under Article 21(2) or (3) of that Directive.
(2.) Before making regulations under paragraph 1, the appropriate authority must consult the relevant food standards authority.
Article 5 

1. When placing products produced from GMOs on the market, operators shall ensure that the following information is transmitted in writing to the operator receiving the product:
(a) an indication of each of the food ingredients which is produced from GMOs;
(b) an indication of each of the feed materials or additives which is produced from GMOs;
(c) in the case of products for which no list of ingredients exists, an indication that the product is produced from GMOs.
2. Without prejudice to Article 6, operators shall have in place systems and standardised procedures to allow the holding of the information specified in paragraph 1 and the identification, for a period of five years from each transaction, of the operator by whom and to whom the products referred to in paragraph 1 have been made available.
3. Paragraphs 1 and 2 shall be without prejudice to other specific requirements in   assimilated  law.
4. Paragraphs 1, 2 and 3 shall not apply to traces of GMOs in products for food and feed produced from GMOs in a proportion no higher than the thresholds established for those GMOs in accordance with Articles 12 or 24  of Regulation (EC) No 1829/2003, provided that these traces of GMOs are adventitious or technically unavoidable.
Article 6 

1. In cases where  other  legislation provides for specific identification systems, such as lot numbering for pre-packaged products, operators shall not be obliged to hold the information specified in Articles 4(1), 4(2), 4(3) and 5(1), provided that this information and the lot number is clearly marked on the package and that information about lot numbers is held for the periods of time referred to in Articles 4(4) and 5(2).
2. Paragraph 1 shall not apply to the first stage of placing on the market of a product or to primary manufacture or re-packaging of a product.
Article 7 
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Article 8 

(1.) An appropriate authority may, by regulations, make provision for the purposes of adapting the system, as amended from time to time, and as relevant, for assigning unique identifiers to GMOs referred to in Articles 2 and 3 of Commission Regulation (EC) No 65/2004.
(2.) Before making regulations under paragraph 1, the appropriate authority—
(a) must take account of developments in international fora, and
(b) must consult the relevant food standards authority.
Article 9 

1. The competent authorities  shall ensure that inspections and other control measures including sample checks and testing (qualitative and quantitative), as appropriate, are carried out to ensure compliance with this Regulation. Inspection and control measures may also include inspection and control regarding the holding of a product.
2. An appropriate authority may—
(a) publish technical guidance on sampling and testing for the purposes of facilitating the implementation of this Regulation;
(b) make provision, by regulations, on sampling and testing for the purposes mentioned in point (a), having first consulted the relevant food standards authority.
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Article 9a 
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Article 10 

1. Regulations made by the Secretary of State or the Welsh Ministers under this Regulation are to be made by statutory instrument.
2. For regulations made by the Scottish Ministers under this Regulation, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 .
4. A statutory instrument containing regulations made by the Secretary of State under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.
5. A statutory instrument containing regulations made by the Welsh Ministers under this Regulation is subject to annulment in pursuance of a resolution of the National Assembly for Wales.
(6.) Regulations made by the Scottish Ministers under this Regulation are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010).
(8.) Such regulations may—
(a) contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);
(b) make different provision for different purposes.
Article 11 
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Article 12 
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Article 13 

1. This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
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