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The Genetic Technology (Precision Breeding) Regulations 2025

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Schedule 5 Consequential Amendments to legislation relating to precision bred organism

Regulation 54 Part 1 Amendment of assimilated direct legislation Amendment to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed 1 (1) Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed is amended as follows. (2) In Article 2, in point 5, after the second reference to “Directive 2001/18 EC”, insert “and, in relation to England, excluding precision bred plants”. (3) At the end of Article 2, insert— 25. ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Amendment to Regulation (EC) No 1830/2003 of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms, etc. 2 (1) Regulation (EC) No 1830/2003 of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms, etc. is amended as follows. (2) After Article 2(2), insert— 3. In relation to England, this Regulation does not apply to— (a) products consisting of, or containing, precision bred plants placed on the market in accordance with Part 2 of the Genetic Technology (Precision Breeding) Act 2023 and regulations made under it; (b) food and feed produced from precision bred plants placed on the market in accordance with Part 3 of the Genetic Technology (Precision Breeding) Act 2023 and regulations made under it. . (3) In Article 3— (a) in point 1, after the second reference to “Directive 2001/18/EC”, insert “and, in relation to England, excluding precision bred plants”; (b) after point 15, insert— 16. ‘Precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Amendment to Regulation (EC) No 1946/2003 of the European Parliament and of the Council on transboundary movements of genetically modified organisms 3 (1) Regulation (EC) No 1946/2003 of the European Parliament and of the Council on transboundary movements of genetically modified organisms is amended as follows. (2) After Article 2(2), insert— 3. In relation to England, precision bred plants are excluded from the scope of this Regulation. . (3) At the end of Article 3, insert— 25. ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Amendment to Regulation (EC) 1332/2008 of the European Parliament and of the Council on food enzymes, etc. 4 (1) Regulation (EC) 1332/2008 of the European Parliament and of the Council on food enzymes, etc. is amended as follows. (2) In the heading to Article 8, at the end, insert “or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023”. (3) After Article 8(2), insert— 3. In relation to England, a food enzyme falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act. 4. In relation to England, when a food enzyme that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under Part 3 of that Act and the food enzyme complies with the specifications established under this Regulation. . Amendment to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives 5 (1) Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives is amended as follows. (2) In the heading of Article 13, at the end, insert “or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023”. (3) After Article 13(2), insert— 3. In relation to England, a food additive falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act. 4. In relation to England, when a food additive that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under Part 3 of that Act and the food additive complies with the specifications established under this Regulation. . Amendment to Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc. 6 (1) Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc. is amended as follows. (2) In the heading of Article 12, at the end, insert “or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023”. (3) After Article 12(2), insert— 3. In relation to England, a flavouring or source material falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act. 4. In relation to England, when a flavouring that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under that Act and the flavouring complies with the specifications established under this Regulation. . Amendment to Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, etc. 7 (1) Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, etc. is amended as follows. (2) In Article 2(2)— (a) in point (g), omit “and”; (b) after point (h), insert— (i) in relation to England, the Genetic Technology (Precision Breeding) Act 2023 and regulations made under it. . Amendment to Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, etc. 8 (1) Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, etc. is amended as follows. (2) In Article 3— (a) at the end of paragraph 16, insert “but, in relation to England, does not include precision bred plants”; (b) after paragraph 34, insert— 35. ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Amendment to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (recast) 9 (1) Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (recast) is amended as follows. (2) After Article 2(2)(g), insert— (ga) in relation to England, precision bred plants. ; (3) After Article 3(26), insert— 27. ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Amendment to Commission Regulation (EU) No 68/2013 on the Catalogue of feed materials 10 (1) Commission Regulation (EU) No 68/2013 on the Catalogue of feed materials is amended as follows. (2) In the Annex— (a) in Part A, in point (2), at the end of the first sentence, insert “and, in relation to England, to the Genetic Technology (Precision Breeding) Act 2023 for feed materials that are or are produced from precision bred plants or result from a fermentation process involving precision bred plants. In this Annex, “precision bred plants” has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023”; (b) in Part C, in chapter 12, after the first sentence, insert “In relation to England, feed materials listed in this chapter that are or are produced from precision bred plants, or result from a fermentation process involving precision bred plants, must be compliant with the Genetic Technology (Precision Breeding) Act 2023.”. Amendment to Regulation (EU) No 1143/2014 of the European Parliament and of the Council on the prevention and management of the introduction and spread of invasive alien species 11 (1) Regulation (EU) No 1143/2014 of the European Parliament and of the Council on the prevention and management of the introduction and spread of invasive alien species is amended as follows. (2) After Article 2(2)(b), insert— (ba) in relation to England, precision bred plants within the meaning of section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023; . Amendment to Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, etc 12 (1) Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, etc. is amended as follows. (2) After Article 2(2)(a), insert— (aa) within England, food produced from precision bred plants within the meaning of section 1, as read with section 2(1), and section 30(2), of the Genetic Technology (Precision Breeding) Act 2023; . Part 2 Amendment of subordinate legislation that applies in Great Britain Amendment to the Genetically Modified Organisms (Contained Use) Regulations 2014 13 (1) The Genetically Modified Organisms (Contained Use) Regulations 2014 are amended as follows. (2) After regulation 3(2)(c), insert— (d) in relation to England, a precision bred plant is released or marketed in cases or circumstances in which the notification or authorisation of the Secretary of State is required under the following provisions of the Genetic Technology (Precision Breeding) Act 2023— (i) section 4 (release of precision bred organism), (ii) section 5 (marketing of precision bred organism), (iii) section 26 (regulation of food or feed produced from precision bred organisms). . (3) After regulation 3(6), insert— (7) In paragraph (2)(d), “precision bred plants” means precision bred plants as defined in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Part 3 Amendment of subordinate legislation that applies in England Amendment to the Environmental Damage (Prevention and Remediation) (England) Regulations 2015 14 (1) The Environmental Damage (Prevention and Remediation) (England) Regulations 2015 are amended as follows. (2) At the end of paragraph 9(2) of Schedule 2, insert “excluding precision bred plants within the meaning of section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.”.

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Schedule 5 Consequential Amendments to legislation relating to precision bred organism

Regulation 54 Part 1 Amendment of assimilated direct legislation Amendment to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed 1 (1) Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed is amended as follows. (2) In Article 2, in point 5, after the second reference to “Directive 2001/18 EC”, insert “and, in relation to England, excluding precision bred plants”. (3) At the end of Article 2, insert— 25. ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Amendment to Regulation (EC) No 1830/2003 of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms, etc. 2 (1) Regulation (EC) No 1830/2003 of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms, etc. is amended as follows. (2) After Article 2(2), insert— 3. In relation to England, this Regulation does not apply to— (a) products consisting of, or containing, precision bred plants placed on the market in accordance with Part 2 of the Genetic Technology (Precision Breeding) Act 2023 and regulations made under it; (b) food and feed produced from precision bred plants placed on the market in accordance with Part 3 of the Genetic Technology (Precision Breeding) Act 2023 and regulations made under it. . (3) In Article 3— (a) in point 1, after the second reference to “Directive 2001/18/EC”, insert “and, in relation to England, excluding precision bred plants”; (b) after point 15, insert— 16. ‘Precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Amendment to Regulation (EC) No 1946/2003 of the European Parliament and of the Council on transboundary movements of genetically modified organisms 3 (1) Regulation (EC) No 1946/2003 of the European Parliament and of the Council on transboundary movements of genetically modified organisms is amended as follows. (2) After Article 2(2), insert— 3. In relation to England, precision bred plants are excluded from the scope of this Regulation. . (3) At the end of Article 3, insert— 25. ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Amendment to Regulation (EC) 1332/2008 of the European Parliament and of the Council on food enzymes, etc. 4 (1) Regulation (EC) 1332/2008 of the European Parliament and of the Council on food enzymes, etc. is amended as follows. (2) In the heading to Article 8, at the end, insert “or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023”. (3) After Article 8(2), insert— 3. In relation to England, a food enzyme falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act. 4. In relation to England, when a food enzyme that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under Part 3 of that Act and the food enzyme complies with the specifications established under this Regulation. . Amendment to Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives 5 (1) Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives is amended as follows. (2) In the heading of Article 13, at the end, insert “or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023”. (3) After Article 13(2), insert— 3. In relation to England, a food additive falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act. 4. In relation to England, when a food additive that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under Part 3 of that Act and the food additive complies with the specifications established under this Regulation. . Amendment to Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc. 6 (1) Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc. is amended as follows. (2) In the heading of Article 12, at the end, insert “or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023”. (3) After Article 12(2), insert— 3. In relation to England, a flavouring or source material falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act. 4. In relation to England, when a flavouring that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under that Act and the flavouring complies with the specifications established under this Regulation. . Amendment to Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, etc. 7 (1) Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, etc. is amended as follows. (2) In Article 2(2)— (a) in point (g), omit “and”; (b) after point (h), insert— (i) in relation to England, the Genetic Technology (Precision Breeding) Act 2023 and regulations made under it. . Amendment to Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, etc. 8 (1) Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, etc. is amended as follows. (2) In Article 3— (a) at the end of paragraph 16, insert “but, in relation to England, does not include precision bred plants”; (b) after paragraph 34, insert— 35. ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Amendment to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (recast) 9 (1) Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (recast) is amended as follows. (2) After Article 2(2)(g), insert— (ga) in relation to England, precision bred plants. ; (3) After Article 3(26), insert— 27. ‘precision bred plant’ has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Amendment to Commission Regulation (EU) No 68/2013 on the Catalogue of feed materials 10 (1) Commission Regulation (EU) No 68/2013 on the Catalogue of feed materials is amended as follows. (2) In the Annex— (a) in Part A, in point (2), at the end of the first sentence, insert “and, in relation to England, to the Genetic Technology (Precision Breeding) Act 2023 for feed materials that are or are produced from precision bred plants or result from a fermentation process involving precision bred plants. In this Annex, “precision bred plants” has the same meaning as in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023”; (b) in Part C, in chapter 12, after the first sentence, insert “In relation to England, feed materials listed in this chapter that are or are produced from precision bred plants, or result from a fermentation process involving precision bred plants, must be compliant with the Genetic Technology (Precision Breeding) Act 2023.”. Amendment to Regulation (EU) No 1143/2014 of the European Parliament and of the Council on the prevention and management of the introduction and spread of invasive alien species 11 (1) Regulation (EU) No 1143/2014 of the European Parliament and of the Council on the prevention and management of the introduction and spread of invasive alien species is amended as follows. (2) After Article 2(2)(b), insert— (ba) in relation to England, precision bred plants within the meaning of section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023; . Amendment to Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, etc 12 (1) Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, etc. is amended as follows. (2) After Article 2(2)(a), insert— (aa) within England, food produced from precision bred plants within the meaning of section 1, as read with section 2(1), and section 30(2), of the Genetic Technology (Precision Breeding) Act 2023; . Part 2 Amendment of subordinate legislation that applies in Great Britain Amendment to the Genetically Modified Organisms (Contained Use) Regulations 2014 13 (1) The Genetically Modified Organisms (Contained Use) Regulations 2014 are amended as follows. (2) After regulation 3(2)(c), insert— (d) in relation to England, a precision bred plant is released or marketed in cases or circumstances in which the notification or authorisation of the Secretary of State is required under the following provisions of the Genetic Technology (Precision Breeding) Act 2023— (i) section 4 (release of precision bred organism), (ii) section 5 (marketing of precision bred organism), (iii) section 26 (regulation of food or feed produced from precision bred organisms). . (3) After regulation 3(6), insert— (7) In paragraph (2)(d), “precision bred plants” means precision bred plants as defined in section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023. . Part 3 Amendment of subordinate legislation that applies in England Amendment to the Environmental Damage (Prevention and Remediation) (England) Regulations 2015 14 (1) The Environmental Damage (Prevention and Remediation) (England) Regulations 2015 are amended as follows. (2) At the end of paragraph 9(2) of Schedule 2, insert “excluding precision bred plants within the meaning of section 1, as read with section 2(1), of the Genetic Technology (Precision Breeding) Act 2023.”.

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