Guidance on nutrition and health claims made on foods

This guidance covers Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, which applies directly in all EU Member States. In each of the UK countries a domestic Regulation or Statutory Instrument is in place, which designates “competent authorities” who will enforce the requirements of the legislation as well as establishing enforcement provisions and penalties. The domestic legislation is:

The Nutrition and Health Claims Regulations (England) 2007 (SI 2007 No. 2080) amended by The Nutrition and Health Claims (England) (Amendment) Regulations 2010 (SI 2010 No. 1768).

The Nutrition and Health Claims Regulations (Scotland) 2007 (SSI 2007 No. 383) amended by The Nutrition and Health Claims (Scotland) Amendment Regulations 2010 (SSI 2010 No. 307).

SECTION 1 – INTRODUCTION AND SUMMARY

1.1 INTRODUCTION

1. When making a voluntary nutrition or health claim you must comply with the requirements of European Regulation (EC) No 1924/2006 on nutrition and health claims made on food. This section provides background information about Regulation 1924/2006 and a brief summary of the key controls it introduces.

2. This is the first piece of specific legislation to deal with nutrition and health claims and seeks to protect consumers from misleading or false claims. It harmonises legislation across the European Community making it easier to trade and aids food business operators in complying with the law. The Regulation will also make it easier for you to identify nutrition and health claims that can justifiably be used on a specific product.

3. If you make, or plan to make, a nutrition or health claim, as well as using the rest of these guidance notes you are advised to consult your Primary Authority/Home Authority (see Section 8.2) where you have one to ensure you meet with the requirements of the Regulation. You should start by reading Sections 2 and 3 of the guidance, which outline the scope of the Regulation and give general information about making claims. By answering the questions at the end of Section 3 you can identify the additional sections of this guidance that are relevant to you. In addition, you may find it helpful to read Section 9, which includes the answers to specific questions about the Regulation.

1.2 BACKGROUND

4. On 30 December 2006 a Regulation of the European Parliament and of the Council of the European Union on nutrition and health claims made on foods was published as Regulation (EC) 1924/2006. A corrigendum with the legal text of the Regulation was published on 18 January 2007. This amends the text that was originally published and reflects the agreed Regulation. In January 2008 two amendments to the Regulation were agreed. Regulation (EC) 107/2008 amends the comitology procedures 2* laid down by the Regulation and Regulation (EC) 109/2008 introduces a transition period for claims referring to children's development and health. A consolidated version of the Regulation, which takes into account these amendments was published on 4 March 2008. A copy of this Regulation can be found on the website of the European Commission .

2* The committee system in the European Union by which legislative decisions are made.

1.3 WHAT IS A NUTRITION CLAIM AND WHAT IS A HEALTH CLAIM?

5. Article 2 defines a nutrition claim as any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to the presence, absence, increased or reduced levels of energy or of a particular nutrient or other substance, and includes claims such as “source of calcium”, “low fat”, “high fibre” and “reduced salt”.

6. Article 2 defines a health claim as any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. This would include claims such as “calcium helps maintain normal bones”. More general claims such as “good for you” may also be health claims, and the Regulation takes these into account.

7. Further advice about what is and is not a nutrition or health claim and what does and does not have to comply with the Regulation can be found in Section 2.

1.4 KEY REQUIREMENTS OF THE REGULATION

8. Although the key requirements of the Regulation are outlined below, there may be more specific requirements not mentioned here. You are therefore recommended to consult the rest of the guidance to ensure you comply with the Regulation.

• Claims must comply with the general requirements of the Regulation as specified in Article 3, which include not being false, ambiguous or misleading, not encouraging or condoning excess consumption of a food and not implying that a balanced diet cannot provide necessary nutrients.

• If a claim is made Article 7 makes it obligatory to provide nutrition labelling in most cases. See sections 4.2 and 5.1 for more information about providing nutrition labelling.

• Article 8 means that only nutrition claims listed in the Annex to the Regulation can be made on food and only if the product meets with the specific conditions of use for that claim. For example, “low fat” can only be made on products containing no more than 3g of fat per 100g for solids.

• Claims must not be made on alcoholic beverages containing more than 1.2% by volume of alcohol, with limited exceptions for reduced energy or reduced alcohol and low alcohol content claims (Article 4).

• Health claims which suggest that health could be affected by not consuming the food cannot be made on food (Article 12).

• Health claims which make reference to the rate or amount of weight loss cannot be made on food (Article 12).

• Health claims which make reference to recommendations of individual doctors or health professionals cannot be made on food (Article 12).

• As specified by Article 10, health claims must be authorised and included in the list of authorised health claims in the EU Register to be used on food. the EU Register will be built up gradually as claims are authorised. Products will also have to meet the specific conditions of use stated.

9. Article 4 of the Regulation puts in place provisions that may restrict the use of claims on certain foods or categories of foods based on their nutritional composition (nutrient profile). Nutrient profiles should have been adopted by 19 January 2009 but this deadline has not been met. According to Article 28 of the Regulation, food business operators will have two years to comply with these controls once the profiles are adopted in Europe.

1.5 EUROPEAN UNION REGISTER OF HEALTH CLAIMS

10. The Regulation puts in place three ways to get claims authorised and added to the EU Register:

i. Before 31st January 2008, Member States submitted lists of claims based on generally accepted scientific evidence to the European Commission which, taking into account opinions of the European Food Safety Authority (EFSA), must decide if claims can be included in the list of authorised health claims in the EU Register. The claims submitted before 31/01/2008 had to be accompanied by references to the relevant scientific justification and conditions of use applying to them (Article 13). The Food Standards Agency submitted the UK's list of candidate health claims on 30 January 2008.
ii. A claim based on new or emerging science and/or proprietary data needs to be accompanied by a dossier of information in support of the claim (Article 18). EFSA will assess this evidence and the Commission will take EFSA's opinion into account when deciding whether the claim should be authorised.
iii. A health claim referring to a reduction in the risk of a disease or to children's development and health also needs to be submitted with a dossier of information in support of the claim for assessment by EFSA (Article 14). The Commission will take EFSA's opinion into account when considering whether the claim should be authorised.

11. Further information about the authorisation of health claims can be found in Section 5. It is, however, important that you also read Section 2, to find out whether the Regulation applies to you, and Section 3, which details the general requirements of the Regulation that apply to all claims.

1.6 KEY DATES (ARTICLE 28)

12. Although the Regulation applied from 1 July 2007, Article 28 puts in place transitional measures that mean you may have until January 2022 to comply with different specific aspects of the Regulation. For full details of the transitional periods, please see Section 7. In some instances, the Regulation does not provide exact end dates for transition periods but instead allows for periods following certain decisions. For example, there is a two-year transitional period for products to comply with the controls relating to nutrient profiles, following their adoption (Article 28).

1.7 HOW TO MAKE A CLAIM

13. Please see Appendix IV for a flow diagram, which will tell you what to do if you want to make a nutrition or health claim.

Additional information of interest
Section 6 gives details of the future control of nutrition and health claims.

Section 8 gives details about enforcement of the Regulation in the UK.

Section 9 gives answers to frequently asked questions.

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