APPLICATIONS DESK UNIT – Last updated: JUL 2018

European Food Safety Authority • Via Carlo Magno 1A • 43126 Parma • ITALY

Tel. +39 0521036111 • Fax +39 05210360110 • http://www.efsa.europa.eu/en/applicationshelpdesk.htm

Relevant regulatory framework, administrative and scientific guidance documents per regulated product area

SCIENTIFIC AREA REGULATORY FRAMEWORK AND GUIDANCE DOCUMENTS

WHERE TO SUBMIT AN APPLICATION

Animal by-products treatments Regulatory framework and Guidance European Commission (EC)

Decontamination substances Regulatory framework and Guidance European Commission (EC)

Feed additives Regulatory framework and Guidance Request for authorisation to (EC) Technical dossier to EFSA

Flavourings Regulatory framework and Guidance European Commission (EC)

Flavourings - Smoke flavourings Regulatory framework and Guidance European Commission (EC)

Food additives Regulatory framework and Guidance European Commission (EC)

Food Contact Materials (FCM) Regulatory framework and Guidance Member State Competent Authorities

Food enzymes Regulatory framework and Guidance European Commission (EC)

GMOs Regulatory framework and Guidance Member State Competent Authorities

Health claims Art. 13.5 & 14.1 Regulatory framework and Guidance Member State Competent Authorities

Novel foods Regulatory framework and Guidance European Commission (EC)

Nutrient sources Regulatory framework and Guidance European Commission (EC)

Pesticides active substances Regulatory framework and Guidance Member State Competent Authorities

Pesticide MRLs Regulatory framework and Guidance Member State Competent Authorities

TSE testing Regulatory framework and Guidance European Commission (EC)

2

Area Regulatory framework Administrative Guidance Scientific Guidance

Animal by-product treatments

Commission Regulation EU 142/2011 of 25 February 2011 implementing Regulation EC Regulation EC 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive

Commission Regulation EU 142/2011 of 25 February 2011 implementing Regulation EC 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive

Format for applications: EFSA Statement on technical assistance on the format for applications for new alternative methods for animal by-products (July 2010) (EFSA-Q-2010-00072)

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3

Area Regulatory framework Administrative Guidance Scientific Guidance

Decontamination substances

Regulation EC 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin Commission Regulation EU 101/2013 of 4 February 2013 concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcasses

Revision of the joint AFC/BIOHAZ guidance document on the submission of data for the evaluation of the safety and efficacy of substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption (April 2010) EFSA Journal 2010; 8(4):1544 [32 pp.]. doi:10.2903/j.efsa.2010.1544 (EFSA-Q-2009-00196)

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4

Area Regulatory framework Administrative Guidance Scientific Guidance

Feed additives Classified into:

Technological additives (e.g. preservatives, antioxidants, emulsifiers, stabilising agents, acidity regulators, silage additives)

Sensory additives (e.g. flavours, colorants)

Nutritional additives (e.g. vitamins, minerals, aminoacids, trace elements)

Zootechnical additives (e.g. digestibility enhancers, gut flora stabilizers)

Coccidiostats and histomonostats

Regulation EC 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition Commission Regulation EC 885/2009 of 25 September 2009 amending Regulation EC 378/2005 as regards reference samples, fees and the laboratories listed in Annex II Regulation EC 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation EC 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives Commission Regulation EC 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation

EFSA Administrative guidance to applicants on the preparation and presentation of applications for authorisation of additives for use in animal nutrition (revised in January 2012) Annex A – Description and conditions of use of the additive

Annex B – Completeness check

list Annex C – Trial protocol data

sheet: aquatic animals Annex C¹ – Trial protocol data

sheet: terrestrial animals Annex D – Preparation of

electronic files

Annex E – Contact details

1. EFSA Guidance on

technological additives (January 2012). EFSA Journal 2012;10(1):2528 (EFSA-Q-2010-00017, EFSA-Q-2010-00902)

2. EFSA Guidance on zootechnical additives (January 2012). EFSA Journal 2012;10(1):2536 (EFSA-Q-2010-01159)

3. EFSA Guidance for the preparation of dossiers for sensory additives (January 2012). EFSA Journal 2012;10(1):2534 (EFSA-Q-2010-01157)

4. EFSA Guidance on nutritional additives (January 2012). EFSA Journal 2012;10(1):2535 (EFSA-Q-2010-01158)

5. EFSA Guidance for the preparation of dossiers for

5

Area Regulatory framework Administrative Guidance Scientific Guidance

Feed additives

EC 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives Annex I (EC Application form

) Regulation EC 67/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation EC 1831/2003 EC application form for the preparation and the presentation of applications and technical dossiers for authorisation for placing a feed additive on the market European Union Register of feed additives

coccidiostats and histomonostats (May 2011). EFSA Journal 2011;9(5):2174 revised on January 2012 (EFSA-Q-2010-01160)

6. Guidance on the assessment

of the safety of feed additives for the consumer EFSA Journal 2017;15(10):5022 (EFSA-Q-2016-00822) (implementation date 1 May 2018)

7. Guidance on the identity,

characterisation and conditions of use of feed additives EFSA Journal 2017;15(10):5023 (FSA-Q-2016-00823) (implementation date 1 May 2018)

8. Guidance on the assessment of the safety of feed additives for the target species EFSA Journal 2017;15(10):5021 (EFSA-Q-2016-00553) (implementation date 1 May 2018)

6

Area Regulatory framework Administrative Guidance Scientific Guidance

Feed additives

9. Guidance on the

characterisation of microorganisms used as feed additives or as production organisms EFSA Journal 2018;16(3):5206 (EFSA-Q-2016-00069; EFSA-Q-2017-00211) (implementation date 1 September 2018)

10. Guidance on the assessment

of the toxigenic potential of Bacillus species used in animal nutrition (May 2014). EFSA Journal 2014;12(5):3665 (EFSA-Q-2013-00303)

11. EFSA Guidance on the

renewal of the authorisation of feed additives (October 2013). EFSA Journal 2013;11(10):3431. (EFSA-Q-2012-00962)

12. EFSA Guidance on additives already authorised for use in food (January 2012). EFSA

7

Area Regulatory framework Administrative Guidance Scientific Guidance

Feed additives

Journal 2012;10(1):2538 (EFSA-Q-2011-01095)

13. Guidance for establishing the safety of additives for the consumer (January 2012). EFSA Journal 2012;10(1): 2537(EFSA-Q-2010-01161)

14. EFSA Guidance on user safety concerning the safety of use of the additive for users/workers (January 2012). EFSA Journal 2012;10(1):2539 (EFSA-Q-2010-01162)

15. Guidance on the safety assessment of Enterococcus faecium in animal nutrition (April 2012) EFSA Journal 2012;10(5):2682 (EFSA-Q-2011-01173)

16. EFSA Guidance on the assessment of microbial

8

Area Regulatory framework Administrative Guidance Scientific Guidance

Feed additives

biomasses for use in animal nutrition (March 2011) EFSA Journal 2011;9(3):2117 (EFSA-Q-2010-00939)

17. EFSA Technical guidance: Tolerance and efficacy studies in target animals (May 2011). EFSA Journal 2011; 9(5):2175 (EFSA-Q-2010-01163)

18. Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use (May 2011) EFSA Journal 2011;9(6):2193 (EFSA-Q-2009-00521)

19. Technical Guidance on the assessment of the toxigenic potential of Bacillus species used in animal nutrition (November 2011). EFSA Journal 2011;9(11):2445 (EFSA-Q-2009-00973)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Feed additives

20. EFSA Technical Guidance: Extrapolation of data from major species to minor species regarding the assessment of additives for use in animal nutrition (September 2008, revised November 2009) doi:10.2903/j.efsa.2008.803 (EFSA-Q-2008-409)

21. EFSA Guidance for the preparation of dossiers for the re-evaluation of certain additives already authorised under Directive 70/524/EEC (September 2008, revised November 2009) doi:10.2903/j.efsa.2008.779 (EFSA-Q-2008-410)

22. EFSA Technical Guidance for assessing the safety of feed additives for the environment (October 2008, revised November 2009) doi:10.2903/j.efsa.2008.842 (EFSA-Q-2008-408)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Feed additives

23. EFSA Technical guidance - Update of the criteria used in the assessment of bacterial resistance to antibiotics of human or veterinary importance (July 2008,updated November 2009)doi:10.2903/j.efsa.2008.732 (EFSA-Q-2008-004)

24. EFSA Technical guidance - Compatibility of zootechnical microbial additives with other additives showing antimicrobial activity (March 2008) doi:10.2903/j. efsa.2008.658 (EFSA-Q-2007-174)

25. EFSA Technical Guidance: Microbial Studies (October 2008)doi:10.2903/j.efsa.2008.836 (EFSA-Q-2008-461)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Flavourings

Common authorisation procedure: Regulation EC 1331/2008 of 16 December 2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings Commission Regulation EU 234/2011 of 10 March 2011 implementing Regulation 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings Regulation EC 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on

EC practical guidance for

applicants on the submission of applications on food additives, food enzymes and food flavourings (September 2011- updated 7 March 2018)

EFSA Guidance on the data required for the risk assessment of flavourings to be used in or on foods (June 2010). EFSA Journal 2010; 8(6):1623 [53 pp.]. doi:10.2903/j.efsa.2010.1623 (EFSA-Q-2009-00004) EFSA Proposed template to be used in drafting scientific opinion on flavouring substances (explanatory notes for guidance included) (November 2011) (EFSA-Q-2011-01133)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Flavourings

foods and amending Council Regulation (EEC) 1601/91, Regulations EC 2232/96 and EC 110/2008 and Directive 2000/13/EC Commission Implementing Regulation EU 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation EC 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation EC 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation EC 1565/2000 and Commission Decision 1999/217/EC Commission Regulation EU

873/2012 of 1 October 2012 on

transitional measures

concerning the Union list of

flavourings and source

materials set out in Annex I to

Regulation EC 1334/2008 of the

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Area Regulatory framework Administrative Guidance Scientific Guidance

Flavourings

European Parliament and of the

Council

Commission Regulation EU 246/2014 of 13 March 2014 amending Annex I to Regulation EC 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances

Flavourings

Group evaluation: Regulation EC 2232/96 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs; sets out the basic rules for the use of flavouring substances in or on foodstuffs in the EU EU Register of food flavourings

EFSA Guidance on the data required for the risk assessment of flavourings to be used in or on foods (June 2010). EFSA Journal 2010; 8(6):1623 [53 pp.]. doi:10.2903/j.efsa.2010.1623 (EFSA-Q-2009-00004) EFSA Proposed template to be used in drafting scientific opinion on flavouring substances (explanatory notes for guidance included) (November 2011) (EFSA-Q-2011-01133)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Flavourings -Smoke flavourings

Regulation EC 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods Commission Regulation EC 627/2006 of 21 April 2006 implementing Regulation EC 2065/2003 of the European Parliament and of the Council as regards quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products Regulation EC 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory

EFSA Guidance on submission of a dossier on a Smoke Flavouring Primary Product for evaluation by EFSA (April 2005). doi:10.2903/j.efsa.2005.492 (EFSA-Q-2003-00240) EFSA Statement on the Safety Evaluation of Smoke Flavourings Primary Products: Interpretation of the Margin of Safety (January 2010). EFSA Journal 2010; 8(1):1325 [7 pp.] (EFSA-Q-2009-00764) EFSA Guidance on Dietary exposure assessment methods for smoke flavouring Primary Products (April 2009). doi:10.2903/j.efsa.2009.248r (EFSA-Q-2008-402)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Flavourings -Smoke flavourings

procedure with scrutiny — Part Four Commission Implementing Regulation EU 1321/2013 of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings

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Area Regulatory framework Administrative guidance Scientific guidance

Food additives

Common authorisation procedure: Regulation EC 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings Commission Regulation EU

EC practical guidance for

applicants on the submission of applications on food additives, food enzymes and food flavourings (September 2011- updated 7 March 2018)

Guidance for submission for food additive evaluations (July 2012). EFSA Journal 2012;10(7):2760 (EFSA-Q-2010-00675) EFSA Data requirements for the evaluation of food additive applications (August 2009). EFSA Journal 2009;1188 (EFSA-Q-2007-188) Guidance on submission for food additive evaluations by the

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Area Regulatory framework Administrative guidance Scientific guidance

Food additives

234/2011 of 10 March 2011 implementing Regulation EC 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings Regulation EC 1333/2008 of 16 December 2008 of the European Parliament and of the Council on food additives Commission Regulation EU 1129/2011 of 11 November 2011 amending Annex II to Regulation EC 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives Commission Regulation EU 1130/2011 of 11 November 2011 amending Annex III to Regulation EC 1333/2008 of the European Parliament and of the Council on food additives by establishing a Union list of food

Scientific Committee on Food. (SCF/CS/GEN/26 Final - July

2001) Food additives intake model (FAIM) template – Version 1.1

(Updated on: 25 July 2013) FAIM template ‘Instructions for

use’ – Version 2.0 (Oct 2017)

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Area Regulatory framework Administrative guidance Scientific guidance

Food additives

additives approved for use in food additives, food enzymes, food flavourings and nutrients Commission Regulation EU 1131/2011 of 11 November 2011 amending Annex II to Regulation EC 1333/2008 of the European Parliament and of the Council with regard to steviol glycosides Commission Regulation EU 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation EC 1333/2008 of the European Parliament and of the Council Re-evaluation: Commission Regulation EU 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation EC 1333/2008 of the European Parliament and of the Council on food additives

18

Area Regulatory framework Administrative guidance Scientific guidance

Food additives

Regulation EU 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations EC 1924/2006 and EC 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation EC 608/2004

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19

Area Regulatory framework Administrative Guidance Scientific Guidance

Food Contact Materials (FCM)

Regulation EC 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC Commission Regulation EC 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food EC FCM database

FCM - Plastic materials

Commission Regulation EU 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food Commission Regulation EU 1282/2011 of 28 November 2011 amending and correcting Commission Regulation (EU)

Administrative Guidance for the preparation of applications for the safety assessment of substances to be used in plastic Food Contact Materials (April 2017) (EFSA-Q-2016-00687) Union Guidelines on Regulation EU 10/2011 on plastic materials and articles intended to come

Note for Guidance For the Preparation of an Application for the Safety Assessment of a Substance to be used in Plastic Food Contact Materials (July 2008 - Update May 2017) (EFSA-Q-2006-00327)

20

Area Regulatory framework Administrative Guidance Scientific Guidance

FCM - Plastic materials

10/2011 on plastic materials and articles intended to come into contact with food Corrigendum to Commission Regulation EU 1183/2012 of 30 November 2012 amending and correcting Regulation EU 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation EU 1183/2012 of 30 November 2012 amending and correcting Regulation EU 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation EU 202/2014 of 3 March 2014 amending Regulation EU 10/2011 on plastic materials and articles intended to come into contact with food

Commission Regulation 2015/174 of 5 February 2015

into contact with food - in support of the implementation of the general requirements of Commission Regulation EU 10/2011 on plastic food contact materials and articles

21

Area Regulatory framework Administrative Guidance Scientific Guidance

amending and correcting Regulation EU 10/2011 on plastic materials and articles intended to come into contact with food

FCM - Recycling process to produce recycled plastic

Commission Regulation EC 282/2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation EC 2023/2006 Update of the Register of valid applications for authorisation of recycling processes to produce recycled plastic materials and articles intended to come into

contact with foods submitted under Article 13 of Regulation EC 282/2008 Register of substances for which a valid application for authorisation was submitted under Regulation EC 450/2009

EC Q&A about Recycling Processes

EFSA guidelines on submission of a dossier for safety evaluation recycling process to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food (July 2008) (EFSA-Q-2004-168)

EFSA guidelines on submission of a dossier for safety evaluation recycling process to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food (July 2008) (EFSA-Q-2004-168)

EFSA Scientific Opinion on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food (July 2011). EFSA Journal 2011;9(7):2184 [25 pp.] (EFSA-Q-2010-01501)

22

Area Regulatory framework Administrative Guidance Scientific Guidance

FCM - Active and intelligent materials and articles

Commission Regulation EC 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food

Register of substances for which a valid application for authorisation was submitted under Regulation EC 450/2009

(Article 8(3) of Commission Regulation EC 450/2009)

Guidelines on submission of a dossier for safety evaluation by the EFSA of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food (July 2009) (EFSA-Q-2005-041) EU Guidance on active and intelligent materials and articles intended to come into contact

with food - in support of the implementation of Commission Regulation EC 450/2009 of 29 May 2009

Guidelines on submission of a dossier for safety evaluation by the EFSA of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food (July 2009) (EFSA-Q-2005-041)

FCM – Ceramics

Commission Directive 2005/31/EC of 29 April 2005 amending Council Directive 84/500/EEC as regards a declaration of compliance and performance criteria of the analytical method for ceramic articles intended to come into contact with foodstuffs

23

Area Regulatory framework Administrative Guidance Scientific Guidance

Council Directive 84/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs

FCM - Regenerated cellulose film

Commission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs

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24

Area Regulatory framework Administrative Guidance Scientific Guidance

Food enzymes

Common authorisation procedure: Regulation EC 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings Commission Regulation EU 234/2011 of 10 March 2011 implementing Regulation EC 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings Regulation EC 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation EC 1493/1999, Directive

EC practical guidance for

applicants on the submission of applications on food additives, food enzymes and food flavourings (September 2011- updated 7 March 2018) Administrative Guidance to applicants on the suitability check of applications for authorisation of food enzymes submitted under Regulation EC 1332/2008

EFSA Guidance of the Scientific Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes (May 2013 - replacing earlier version published on 23 July 2009). doi:10.2903/j.efsa.2009.1305 (EFSA-Q-2007-080) Explanatory Note for the Guidance of the Scientific Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes (July 2011, last updated 14 November 2014). (EFSA-Q-2014-00750) EFSA Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use (June 2011) (EFSA-Q-2009-00521) EFSA Journal 2011;9(6):2193 [54 pp.].

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Area Regulatory framework Administrative Guidance Scientific Guidance

Food enzymes

2000/13/EC, Council Directive 2001/112/EC and Regulation EC 258/97 Commission Implementing Regulation EU 562/2012 of 27 June 2012 amending Commission Regulation EU 234/2011 with regard to specific data required for risk assessment of food enzymes Commission Regulation EU 1056/2012 of 12 November 2012 amending Regulation EC 1332/2008 of the European Parliament and of the Council on food enzymes with regard to transitional measures

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26

Area Regulatory framework Administrative Guidance Scientific Guidance

Genetically modified organisms for feed uses and cultivation

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

1. Technical Note on the quality

of DNA sequencing for the

molecular characterisation of

genetically modified plants.

EFSA Journal

2018;16(7):5345 (EFSA-Q-

2017-00706)

2. Guidance on allergenicity

assessment of genetically

modified plants. EFSA

Journal 2017;15(6):4862 [49

pp.]. (EFSA-Q-2014-00547)

3. Explanatory note on the

selection of forage material

suitable for the risk

assessment of GM feed of

plant origin (EFSA-Q-2017-

00614)

4. Explanatory note on literature

searching conducted in the

context of GMO applications

for (renewed) market

Genetically modified organisms for all uses

Regulation EC 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed

Commission Implementing Regulation EU 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation EC 1829/2003 of the European Parliament and of the Council and amending Commission Regulations EC 641/2004 and EC 1981/2006

EFSA guidance on the submission of applications for authorisation of genetically modified plants under Regulation EC 1829/2003 (December 2013). EFSA Journal 2013;11(12):3491 [133 pp.] (EFSA-Q-2009-00900)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Genetically modified organisms for all uses

The EU register of genetically modified food and feed

authorisation and annual

post-market environmental

monitoring reports on GMOs

authorised in the EU market

(EFSA-Q-2017-00248)

5. Guidance on the agronomic

and phenotypic

characterisation of genetically

modified plants. EFSA

Journal 2015;13(6):4128[44

pp.] (EFSA-Q-2013-00606)

6. Explanatory note on DNA

sequence similarity searches

in the context of the

assessment of horizontal

gene transfer from plants to

microorganisms (2017)

(EFSA-Q-2017-00418)

7. Guidance for renewal

applications of genetically

modified food and feed

authorised under Regulation

EC 1829/2003. EFSA Journal

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Area Regulatory framework Administrative Guidance Scientific Guidance

Genetically modified organisms for all uses

2015;13(6):4129 [8 pp.]

(EFSA-Q-2013-00684)

8. Guidance for the risk

assessment of the presence

at low level of genetically

modified plant material in

imported food and feed under

Regulation EC 1829/2003.

DOI:10.2903/j.efsa.2017.504

8 (EFSA-Q-2015-00433)

9. EFSA Guidance on food and

feed from GM animals and on

animal health and welfare

aspects (January 2012).

EFSA Journal

2012;10(1):2501 [43 pp.]

(EFSA-Q-2007-069)

10. EFSA Guidance on Post-market environmental monitoring (PMEM) of GM plants (August 2011). EFSA Journal 2011;9(8):2316 [40 pp.] (EFSA-Q-2010-01253)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Genetically modified organisms for all uses

11. EFSA Guidance on the Risk

assessment of GM microorganisms and their products intended for food and feed use (June 2011). EFSA Journal 2011;9(6):2193 [54 pp.] (EFSA-Q-2009-00521)

12. EFSA Guidance for risk assessment of food and feed from GM plants (May 2011). EFSA Journal 2011; 9(5): 2150 [37 pp.] (EFSA-Q-2008-05020)

13. EFSA Guidance for the risk assessment of genetically modified plants and derived food and feed (May 2011). EFSA Journal 2011; 9(5):2149 [20 pp.] (EFSA-Q-2009-00550)

14. EFSA Guidance on environmental risk assessment of GM plants (November 2010). EFSA

30

Area Regulatory framework Administrative Guidance Scientific Guidance

Journal 2010;8(11):1879 [111 pp.] (EFSA-Q-2008-089 , EFSA-Q-2008-262)

15. EFSA Scientific Opinion on

potential impacts on non-

target organisms (November

2010). EFSA Journal

2010;8(11):1877 [72 pp.]

(EFSA-Q-2008-089)

16. EFSA Scientific Opinion on

the assessment of

allergenicity of GM plants and

microorganisms and derived

food and feed (July 2010).

EFSA Journal 2010;

8(7):1700 [168 pp.] (EFSA-Q-

2005-125)

17. EFSA Scientific Opinion on statistical considerations including field trials (May 2010). EFSA Journal 2010; 8(1):1250 [59 pp.] (EFSA-Q-2006-080)

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Area Regulatory framework Administrative Guidance Scientific Guidance

18. EFSA Scientific Opinion on Guidance for the risk assessment of genetically modified plants used for non-food or non-feed purposes (August 2009). EFSA Journal 2009; 7(8):1164 (EFSA-Q-2007-176)

19. Safety and Nutritional

Assessment of GM Plants

and derived food and feed:

The role of animal feeding

trials (March 2008).

doi:10.2903/j.efsa.2008.1057

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Area Regulatory framework Administrative Guidance Scientific Guidance

Health claims Chapter IV Reg. EC 1924/2006

Art 13.5 New function health

Regulation EC 1924/2006 of the European Parliament and of the council of 20 December 2006 on nutrition and health claims made on foods Commission Regulation EC

Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2) (31January 2017) EFSA Journal 2017;15(1):4680

1. General scientific guidance for stakeholders on health claim applications (January 2016) EFSA Journal 2016;14(1):4369 (EFSA-Q-2014-00353)

32

Area Regulatory framework Administrative Guidance Scientific Guidance

claims

Art. 14 Claims referring to: reduction of disease risk and to children’s development and health

Health claims Chapter IV Reg. EC 1924/2006

353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation EC 1924/2006 of the European Parliament and of the Council Commission Regulation EC 1169/2009 of 30 November 2009 amending Regulation EC 353/2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation EC 1924/2006 of the European Parliament and of the Council 2013/63/EU: Commission Implementing Decision of 24 January 2013 adopting guidelines for the implementation of specific conditions for health claims laid down in Article 10 of Regulation EC 1924/2006 of the European Parliament and of the Council

Appendix A: Application form

(mandatory) Appendix B: Summary of the

application (mandatory)

Appendix: Parts 1-6

EC Guidance on the implementation of Regulation EC N° 1924/2006 on Nutrition and Health Claims made on food approved by the Standing Committee on the Food Chain and Animal Health on 14 December 2007

2. EFSA Guidance on the scientific requirements for health claims related to functions of the nervous system, including psychological functions (July 2012). EFSA Journal 2012;10(7):2816 (EFSA-Q-2010-01185)

3. EFSA Guidance on the scientific requirements for health claims related to physical performance (July 2012). EFSA Journal 2012;10(7):2817 (EFSA-Q-2010-01186)

4. EFSA Guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health (May 2012) EFSA Journal 2012;10(5):2702 (EFSA-Q-2010-01184)

5. EFSA Guidance on the scientific requirements for health claims related to

33

Area Regulatory framework Administrative Guidance Scientific Guidance

Commission Regulation EU 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health EU Register of Nutrition and health claims made on food

appetite ratings, weight management, and blood glucose concentrations (March 2012) EFSA Journal 2012;10(3):2604 (EFSA-Q-2010-01183)

6. EFSA Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health (December 2011) EFSA Journal 2011;9(12);2474 (EFSA-Q-2010-01182)

7. Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms (January 2016) EFSA Journal 2016;14(1):4369 (EFSA-Q-2014-00353)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Nutrition claims Chapter III Regulation Reg. EC 1924/2006

Regulation EC 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods Commission Regulation EU 1047/2012 of 8 November 2012 amending Regulation EC 1924/2006 with regard to the list of nutrition claims EU Register of Nutrition and health claims made on food

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Area Regulatory framework Administrative Guidance Scientific Guidance

Novel foods

Commission Implementing Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. Commission Implementing Regulation (EU) 2017/2468 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. Commission Implementing Regulation (EU) 2017/2470 on establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods (see

Administrative guidance on the submission of applications for authorisation of a novel food pursuant to Article 10 of Regulation (EU) 2015/2283 (EFSA-Q-2017-00291) 97/618/EC: Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation EC 258/97 of the European Parliament and of the Council

Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation EU 2015/2283 (September 2016) EFSA Journal 2016;14(11):4594 (EFSA-Q-2014-00216) Guidance on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation EU 2015/2283 (September 2016) EFSA Journal 2016;14(11):4590 (EFSA-Q-2015-00108)

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Area Regulatory framework Administrative Guidance Scientific Guidance

also chapter 3.3) Regulation EC 258/1997 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients Regulation EU 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods Novel Food Catalogue of authorised Novel Foods and Novel Food Ingredients Commission Regulation EC 1852/2001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation EC 258/97

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37

Area Regulatory framework Administrative Guidance Scientific Guidance

Infant formulae

Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC

EC Report of the Scientific Committee on Food on the Revision of Essential Requirements of Infant Formulae

and Follow-on Formulae (Adopted on 4 April 2003)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Food allergies

Directive 2003/89/EC of the European Parliament and of the Council of 10 November 2003 amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs

Guidance on the preparation and presentation of applications pursuant to Article 6 Paragraph 11 of Directive 2000/13/EC, as amended (October 2013) EFSA Journal 2013;11(10):3417 (EFSA-Q-2013-00221) Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Scientific and technical guidance for the preparation and

38

Area Regulatory framework Administrative Guidance Scientific Guidance

Food allergies

presentation of applications pursuant to Article 6 Paragraph 11 of Directive 2000/13/EC, as amended (October 2013) EFSA-Q-2013-00430

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Area Regulatory framework Administrative Guidance Scientific Guidance

Nutrient sources

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements Regulation EC 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods Commission Directive 2006/37/EC of 30 March 2006 amending Annex II to Directive

EC Administrative guidance on submissions for safety evaluations of substances added for specific nutritional purposes in the manufacture of foods (February 2004 – Revised

April 2012)

EC Guidance on submissions for safety evaluations of sources of nutrients or of other ingredients proposed for use in the manufacture of foods (July 2001)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Nutrient sources

2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances Commission Regulation EC 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation EC 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements Commission Regulation EU 1161/2011 of 14 November 2011 amending Directive 2002/46/EC of the European Parliament and of the Council, Regulation EC 1925/2006 of the European Parliament and of the Council and Commission Regulation EC 953/2009 as regards the lists of mineral substances that can be added

40

Area Regulatory framework Administrative Guidance Scientific Guidance

Nutrient sources

to foods Commission Regulation EU 119/2014 of 7 February 2014 amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation EC 1925/2006 of the European Parliament and of the Council as regards chromium enriched yeast used for the manufacture of food supplements and chromium(III) lactate tri-hydrate added to foods Regulation EU 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council

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Area Regulatory framework Administrative Guidance Scientific Guidance

Nutrient sources

and Commission Regulations EC 41/2009 and EC 953/2009 Commission Regulation EC 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses Commission Implementing Regulation EU 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation EC 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods EC list of authorised nutrient sources

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42

Area Regulatory framework Administrative Guidance Scientific Guidance

Pesticides active substances

Regulation EC 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC Commission Implementing Regulation EU 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation EC 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Commission Regulation EU 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation EC 1107/2009 of the European

Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation EU 844/2012 (12 December 2014)

EC guidance documents on Active substances (European Commission’s Standing Committee on Plants, Animals, Food and Feed – phytopharmaceuticals) Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation EC 1107/2009 (February 2011) (EFSA-Q-2009-00827) Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment (March 2013) (EFSA-Q-2012-00760) Guidance on the assessment of exposure of operators, workers,

43

Area Regulatory framework Administrative Guidance Scientific Guidance

Pesticides active substances

Parliament and of the Council concerning the placing of plant protection products on the market Commission Regulation EU 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation EC 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market

residents and bystanders in risk assessment for plant protection products (October 2014) (EFSA-Q-2011-01062) Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees) (July 2013) (EFSA-Q-2011-00418) Guidance on the Use of Probabilistic Methodology for Modelling Dietary Exposure to Pesticide Residues (October 2012) EFSA-Q-2008-754 Opinion on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil - Scientific Opinion of the Panel on Plant Protection Products and their Residues (PPR Panel) (January 2008) (EFSA-Q-2007-048)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Pesticides active substances

EC working document on the procedure for application of basic substances to be approved in compliance with Article 23 of Regulation EC 1107/2009 (Application template

available from Annex I)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Pesticides MRLs

Regulation EC 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC

EC guidance documents on MRLs (European Commission’s Standing Committee on Plants, Animals, Food and Feed – phytopharmaceuticals) Reporting data on pesticide residues in food and feed according to Regulation EC 396/2005 (2014 data collection) (July 2015) (EFSA-Q-2015-00369)

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Area Regulatory framework Administrative Guidance Scientific Guidance

Pesticides MRLs

Guidance on the Use of Probabilistic Methodology for Modelling Dietary Exposure to Pesticide Residues (October 2012) (EFSA-Q-2008-754)

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Area Regulatory framework Administrative Guidance Scientific Guidance

TSE testing

Opinion of the Scientific Panel on biological hazards (BIOHAZ): Protocol for the evaluation of new rapid BSE post mortem tests (June 2007) (EFSA-Q-2007-053) Opinion of the Scientific Panel on biological hazards (BIOHAZ) - Protocol for the evaluation of rapid post mortem tests to detect TSE in small ruminants (June 2007) (EFSA-Q-2007-055) Scientific Opinion of the Panel on Biological Hazards: Protocol for a preliminary evaluation of ante-mortem TSE tests for ruminants (October 2007) (EFSA-Q-2007-054)

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