PAGB FOOD SUPPLEMENTS ADVERTISING GUIDELINE March 2013 Contents 1. INTRODUCTION 4 2. THE PAGB APPROVAL SYSTEM FOR CONSUMER ADVERTISING 5 2.1. Submitting Promotional Materials for PAGB Approval 6 2.2. How to Submit Promotional Materials 6 2.3. Review Time 7 2.4. Tips on Speeding up the Process 7 2.5. Members’ Responsibilities 7 2.6. Liability 8 3. BACKGROUND TO THE CHANGING REGULATORY FRAMEWORK 10 3.1. Regulation (EC) No 1924/2006 on Nutrition and Health Claims made on Foods 10 3.2. Council Directive 2008/100 on Nutrition Labelling for Foodstuffs 12 3.3. Advertising Codes of Practice 12 4. ADVERTISING CHECKLIST 13 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 13 13 13 14 14 14 14 15 15 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 5. Does the Material need to be submitted to PAGB for Approval? Claims Must be Understood by the Average Consumer Availability of Nutrients from a Varied Diet Medicinal Claims Tonic Claims General Health and Wellbeing Claims Energy Claims Disease Risk Reduction Claims Health Professional Endorsement Recommendations from International Associations of Medical, Nutrition and Dietetic Professionals Recommendations from Health-Related Charities and Other Associations Product Recommendations of Charities and Donations to Charities and Other Associations Celebrities Comparisons Nutrition Claims Sufficient Quantity in Order to Make Claims ‘Source of Vitamins and Minerals’ or ‘Contains Vitamins and Minerals’ ‘High In’ Claims ‘Complete’ Claims Health Claims - Flexibility of Wording 16 16 16 17 17 17 17 18 18 18 19 EVIDENCE CHECKLIST 21 21. Has the claim been authorised by the European Commission or received a favourable opinion from EFSA? 22. Have you already submitted evidence to PAGB for this claim? 21 21 2 23. If this is a new claim, please submit evidence. 24. Regulatory/ Medical Department Sign-Off 21 22 Approval Flowchart - Health Claims 23 Approval Flowchart – Nutrition Claims 23 Appendix 1: Important Links 25 Appendix 2: Recommended Daily Allowances 28 Appendix 3: Transitional Arrangements for Health Claims 29 Appendix 4: Children’s Claims - Article 13 or Article 14? 31 Appendix 5: Permitted Nutrition Claims 32 Appendix 6: Quick Assessment Chart - Claims 36 Appendix 7: Organisations Involved in the Self-Regulation of Food Supplements Advertising in the UK 36 3 1. Introduction This guideline is intended to assist members in preparing food supplement promotional materials for PAGB approval. The way in which food supplement advertising is regulated has changed enormously over the last few years. The Regulation (EC) No 1924/2006 on Nutrition and Health Claims made on Foods (NHCR) came into force on 1 July 2007 and includes several complex transition periods. The guideline includes an introduction to the Nutrition and Health Claims Regulation, explains the PAGB approval process for consumer advertising and includes an Advertising Checklist to assist members in preparing promotional materials which comply with the regulatory and self-regulatory requirements. The Advertising Checklist explains which materials require PAGB approval, provides a list of the standards which PAGB applies when reviewing such materials and outlines the legal and/or the self-regulatory basis for those standards. The Checklist is intended as a useful reminder as to the main requirements which apply to food supplement promotional materials within the UK. It includes those issues which commonly arise when PAGB reviews promotional materials for its member companies. The list does not include every food supplement-specific requirement and does not include the general advertising requirements which apply to all consumer goods. When reviewing promotional materials, PAGB may request amendments which are not included in this Checklist. We are always happy to explain the basis for our comments. A number of appendices have also been included in this guideline: Appendix 1 contains links to relevant codes, guidelines, regulations and other important information Appendix 2 provides the Recommended Daily Allowances (RDAs) Appendices 3 and 4 provide more detailed information on the Nutrition and Health Claims Regulation, in particular the transition periods and claims relating to children Appendix 5 contains the list of permitted Nutrition Claims Appendices 6 and 7 provide ‘Quick Assessment Charts’ for food supplement promotional materials, which you may find useful when reviewing your own promotional materials Appendix 8 contains information on organisations involved in the self-regulation of food supplements advertising in the UK, including the Committee of Advertising Practice, the Advertising Standards Authority, the Radio Advertising Clearance Centre, Clearcast and the Cinema Advertising Association. 4 2. The PAGB Approval System for Consumer Advertising Specialist staff at PAGB carry out the pre-publication approval of advertising materials. PAGB has access to independent medical and legal expertise to advise on evidence and matters of evidence or interpretation. The system of pre-publication approval is as follows: The member company, or agents working on behalf of the member company, produces the draft advertisement or pack1 and submits it to PAGB for approval. PAGB checks the advertisement against the relevant regulations and codes of practice. Any claim-substantiation or legal queries are referred to PAGB’s medical and/or legal advisers. PAGB notifies the member company, or agents working on behalf of the member company, of any changes required or evidence needed before the advertisement can be approved. Once PAGB is satisfied that the advertisement is acceptable, it is approved, subject to ‘PAGB’s Terms of Approval for Advertising’ and the company is notified. The advertisement can now be published/broadcast. (Depending on the intended advertising media, the advertisement may also need to be approved by organisations such as Clearcast (for television advertising), the Radio Advertising Clearance Centre (RACC) or the Cinema Advertising Association (CAA). PAGB’s Approval System for Consumer Advertising Company produced draft advertisement PAGB Medical, legal and nutrition advisers Current regulatory and selfregulatory requirements Company asked to amend the advertising and resubmit to PAGB PAGB approval Advertisement ready to be used 1 This refers to the promotional text and graphics only. Members may also request that PAGB carry out an optional labelling check. 5 2.1. Submitting Promotional Materials for PAGB Approval It is a condition of membership that all food supplement promotional materials aimed at consumers must be approved by PAGB prior to their release into the public domain. PAGB offers informal advice on promotional concepts in order to help avoid major changes being required later in the review process. Please note that once the final draft is ready for submission, it should undergo internal compliance checks before it is submitted for PAGB approval. PAGB is unable to provide approvals post-publication. The section below explains the procedures that member companies and associate members should follow when submitting advertising to PAGB for approval. Food supplement packaging must be submitted for PAGB to approve the promotional text and graphics. Members may also request that PAGB carry out an optional labelling check. PAGB recommends that members also submit the text to PAGB before the artwork is produced. Where a company has more than one pack size, and where the text and graphics are identical on each pack with the only exception being the number of capsules or similar, then only one pack size should be submitted to PAGB for approval. For posters and point-of-sale advertising the final artwork must be submitted for approval. PAGB recommends that members also submit the text to PAGB before the artwork is produced. For press advertisements consisting of text with the addition of a photograph or pack shot, members may submit the text and photograph without needing to resubmit the final layout. If there are any changes to the text during layout stage, the item must be resubmitted for approval. For television commercials and other videos, the script must be submitted to PAGB for approval. PAGB also strongly recommends that the storyboard is submitted before the commercial is produced. The final film must also be submitted for approval, preferably in Mpeg format. Radio scripts must be submitted for approval. Should there be any concerns about how the script is finally executed, PAGB may also request that an audio file is supplied for approval. For Internet materials, PAGB requires a file that can be viewed offline. This enables PAGB to add comments and to keep an accurate record of what has been reviewed and subsequently approved. PAGB prefers to receive offline versions as PDF or Word documents. Where the offline version does not include the final visuals, members are asked to supply a link to the development site. This also applies to animated advertisements, such as banner ads, e.g. animated gif or flash files. For all other items, if in doubt as to what should to be submitted, please contact PAGB for advice. 2.2. How to Submit Promotional Materials In general, a faster response can be achieved if advertising is submitted by email. This enables PAGB to respond electronically and it avoids the problems of legibility associated with faxing. Please send advertising copy to: 6 Email: copyclearance@pagb.co.uk Fax: 020 7405 7719 Post/courier: Advertising Department PAGB Vernon House Sicilian Avenue London WC1A 2QS Please make sure you include your contact details, including phone number. PAGB may wish to contact you to discuss your advertisement before making comments or giving approval. Please remember that it is only members and associate members who can access PAGB’s copy clearance service. If member companies are working with PR, advertising or marketing agencies that are not associate members of PAGB, then all materials must be submitted to PAGB by the member company. 2.3. Review Time Please allow plenty of time for your advertising copy to be assessed. PAGB processes copy in the order in which it is received. Although we aim to review advertising copy within one working day of receipt, we do not promise or guarantee to do so. PAGB are unable to offer feedback in less than one working day. Advertisers should note that large or complicated pieces of copy, or claims requiring detailed consideration of supporting evidence, take longer to assess. PAGB aims to review packaging and websites within five working days. The same timescales apply to each subsequent occasion on which the advertisement is sent back to PAGB with revisions. Member companies are reminded to allow for extra time in which PAGB can obtain an expert medical or legal opinion. This is particularly important for new products or where new claims are being submitted. In such cases, please allow five working days for PAGB to obtain an opinion on the proposed claims. 2.4. Tips on Speeding up the Process Please submit the evidence with the advertisement. If you are re-submitting advertising to PAGB, please highlight the changes and attach the previous version. This makes it much quicker for PAGB to respond to your enquiry. Highlighting changes is essential when submitting website alterations and updates. When planning advertising for new products, companies may find it useful to submit a list of proposed claims, together with supporting evidence. Agreeing the claims in advance will make it quicker for PAGB to review subsequent advertising copy. Please note that the acceptability of individual claims will depend on the context in which they are used. 2.5. Members’ Responsibilities Member companies remain obliged to ensure that their advertising complies in all respects with all applicable legal, regulatory and self-regulatory requirements and that they hold appropriate evidence to support claims made in their promotional materials. PAGB approval is only one element of member companies’ necessary due diligence. 7 PAGB approval is given on the basis of PAGB’s understanding and knowledge of relevant requirements and practice and on the information available to PAGB at the time of approval. This includes any evidence provided to PAGB by the relevant member company or on its behalf. Relevant requirements (and their interpretation) may change from time to time and their application and interpretation are a matter for the appropriate regulatory authorities and/or the courts. It is member companies’ responsibility to respond to, or seek fresh approvals as a result of changes in relevant requirements (and/or their interpretation by the appropriate regulatory authorities or the courts) and/or in available evidence. Member companies must not continue to use advertising materials that are no longer appropriate, for example: Any claim that a product is 'new' or ‘now available’ is only acceptable for one year from the date when the product is first available for consumers to purchase Where a complaint has been upheld against PAGB-approved copy by a regulatory body such as the ASA. If a complaint is upheld, the advertising must be amended or discontinued in line with the ruling of the regulatory body Where new information becomes available, such as a change in the law, a change in an applicable code of practice, new guidelines issued by one of the regulatory bodies or new evidence relevant to the product, or any other products with which a comparison has been made. The advertising must be reviewed in the light of the new information and, if necessary, changed and resubmitted to PAGB for approval, or discontinued. 2.6. Liability Neither PAGB nor any of its officers, employees, agents or advisers shall have any liability (whether in contract, tort or otherwise) for any loss, damage, liability, cost, claim and/or expense suffered or incurred by any person, firm or company as a result of: Any approval (or refusal or failure to give, or delay in giving, approval) by or on behalf of PAGB Any advice, direction, guidance, recommendation or instruction given (whether with or without negligence) by or on behalf of PAGB in connection with any advertising submitted to PAGB for its approval and all such losses (including but not limited to indirect, special, consequential or economic loss and loss of profit) are expressly excluded to the fullest extent permitted by law, but this shall not limit or exclude any liability for fraud, nor for death or personal injury caused by negligence. Each member company shall indemnify and keep indemnified PAGB and each of its officers, employees, agents and advisers against all and any losses, damages, liabilities, costs (including legal costs on an indemnity basis), claims and/or expenses suffered or incurred by or on behalf of any of them in connection with any advertising (or proposed advertising) by or on behalf of that member company, except where the relevant loss, damage, liability, cost, claim and/or expense is incurred wholly and directly as a result of fraud, wilful default and/or negligence of PAGB, its officers, employees, agents and/or advisers. The enforcement and interpretation of legislation is a matter for the applicable regulatory body and/or the courts, not PAGB. While PAGB may be willing to provide advice to members on the law, that advice reflects only the opinion of PAGB and PAGB accepts no responsibility for that advice. The legal responsibility for advertising remains with the advertiser. 8 9 3. Background to the Changing Regulatory Framework Food supplement advertising is currently in a period of enormous transition. The Regulation (EC) No 1924/2006 on Nutrition and Health Claims made on Foods (NHCR) came into force on 1 July 2007. This regulation brought about major changes to the way in which nutrition and health claims are regulated, the extent of which will only become clear through use and in time. 3.1. Regulation (EC) No 1924/2006 on Nutrition and Health Claims made on Foods The Nutrition and Health Claims Regulation applies to claims made in commercial communications aimed at the final consumer (Article 1). It does not control claims made in materials aimed at health professionals or trade. The picture as to whether the Regulation applies to claims made in the press is more complex. Recital 4 of the Regulation states ‘It should not apply to claims which are made in non-commercial communications, such as dietary guidelines or advice issued by public health authorities and bodies, or noncommercial communications and information in the press and in scientific publications.’ Advice received from Department of Health indicates that where a press release is intended to make people aware of food ingredients/ products in order to encourage sales, this is likely to be viewed as a commercial communication and the Regulation will apply. Where the information is presented for scientific or informative purposes, this is not a commercial communication and the regulation will not apply. The Regulation defines nutrition and health claims as follows: Nutrition claims: 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 nutrient or other substance. Nutrition claims are only permitted if they are included in the Annex to the Regulation. Health claims: any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. The different types of health claim are described in Article 10, Article 13 and Article 14 of the Nutrition and Health Claims Regulation. Article 10 Health Claims Article 10 claims are general non-specific benefits, for example “good for you” or “support your health”. These types of claims must be accompanied by specific authorised Article 13 or Article 14 claims. Recently issued guidance from the EU Commission on the use of Article 10 health claims defines “accompanied by” as “next to” or “directly following on from”. Article 13 Health Claims Article 13 refers to three categories of health claims: 1a. the role of a nutrient or other substance in the growth, development and the functions of the body (e.g. ‘calcium and vitamin D are needed for the maintenance of normal bone’) 1b. psychological and behavioural functions (e.g. ‘helps with concentration’) 10 1c. slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or a reduction in the available energy from the diet (e.g. ‘helps you to feel full for longer’) Article 14 Health Claims Article 14 refers to two categories of health claims: 1. Reduction of disease risk (e.g. ‘plant sterols have been shown to reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’) 2. Claims referring to children’s development and health (e.g. ‘calcium and vitamin D are needed for normal growth and development of bone in children’). These health claims refer solely referring to the development and health of children aged up to 18 years, and where the scientific substantiation only relates to children. It also includes health claims used on products intended exclusively to children, including follow on formulae and cereal-based baby foods, as defined by Directive 2006/141/EC and Directive 2006/125/EC. Current Arrangements The current arrangements are as follows: Article 13 (1a) claims may only be used if they have been authorised and have been placed on the Community Register of Nutrition and Health Claims made on food. Regulation 432/2012 authorised just over 200 claims which are now on this register; those claims which did not receive favourable opinions and were not authorised have also been placed on the Register as “non-authorised” and these cannot be used. There are a number of claims outstanding which have not yet been assessed, largely for so called “botanicals”. The European Commission is currently evolving methodology for assessing and authorising (or rejecting) such claims. These claims can continue to be used until they are either passed into law or rejected by an amending Regulation. Article 13 (1b and 1c) may only be used if the claim was in use before 19 January 2007 and an application for authorisation has been submitted. Article 14 children’s claims may continue to be used if the claim was in use before 19 January 2007 and an application for authorisation has been submitted. All new children’s claims must be authorised by the European Commission prior to use. Article 14 disease risk reduction claims must be authorised by the European Commission prior to use. Authorisation of Health Claims The authorisation of health claims is a two stage process. Firstly, EFSA provides an opinion on the scientific data. The European Commission, in discussion with Member States, then decides whether or not the claim will be authorised. The details of the process differ depending on the type of health claim. Please refer to the Regulation for details. The Community Register of Health Claims has been published and the transition period has expired, advertisers are only able to make the health claims included in that Register. Some 11 flexibility of wording is permitted, but recently issued guidance advises that Regulators prefer the approved wording and where flexibility is applied this must not exaggerate claims beyond the original meaning of the published, authorised claim. Advertisers are therefore advised to treat flexibility of wording with caution. Advertisers must comply with any conditions for the use of published claims, some of which are complex. PAGB is happy to discuss and explain conditions of use if this is required. Trademarks The Nutrition and Health Claims Regulation also applies to trademarks and other brand names which may be construed as nutrition or health claims. Trademarks and brand names that imply nutrition or health claims do not have to be authorised but must be accompanied by a related claim which is authorised. Trademarks and brand names in use before January 2005 do not have to comply with the Regulation until 2022. Please refer to Article 1 (3) and Article 28 (2) of the Nutrition and Health Claims Regulation for details. 3.2. Council Directive 2008/100 on Nutrition Labelling for Foodstuffs Regulation 2008/100 was published on 28 October 2008, and came into force on 31 October 2012. This Directive amended the RDAs and hence impacts on the claims permitted in advertising. See points 15-18 of the Checklist, together with Appendix (2) for details. 3.3. Advertising Codes of Practice The UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (the CAP Code) and the UK Code of Broadcast Advertising (the BCAP Code, which covers both TV and radio advertising) can be downloaded from www.cap.org.uk and should be considered alongside PAGB’s guidance. 12 4. ADVERTISING CHECKLIST 1. Does the Material need to be submitted to PAGB for Approval? 1a. Does the item mention a product name or an umbrella brand? 1b. Is it aimed at consumers? 1c. Do you have editorial control? If the answer to all three of these is ‘yes’, the item must be submitted to PAGB for approval. NB. Food supplement packaging must be submitted for PAGB to approve the promotional text and graphics. Members may also request that PAGB carry out an optional labelling check. All materials placed on product-branded websites must be submitted to PAGB for approval, whether or not the piece in question mentions a product brand. PAGB does not approve materials aimed at professionals/trade; PR materials which are likely to be changed by an editor; or materials that provide information on ingredients but which do not mention any product brands. These materials must nonetheless comply with all relevant regulatory and self-regulatory requirements and the point they leave the company’s editorial control. 2. Claims Must be Understood by the Average Consumer Remember that claims need to be understood by the average consumer. (This effectively prohibits the use of nutrition and health claims in materials aimed at children.) (Why? NHCR Preamble (16) and Article 13 (1cii).) 3. Availability of Nutrients from a Varied Diet Advertising must not suggest that it is difficult to obtain adequate quantities of nutrients from a varied diet (exception: folic acid in pregnancy and vitamin D for specified at risk groups). For example: ‘Even if you eat healthily it is difficult to get all the vitamins and minerals you need’ would not be acceptable as it implies that it is difficult to obtain an adequate vitamin and mineral intake from healthy eating alone. ‘If you are not managing to eat healthily you may benefit from a daily vitamin and mineral supplement’ would be acceptable as the person is not currently eating a balanced diet. (Why? NHCR Article 3 (d) and CAP Code 15.8, BCAP 13.7.) 13 4. Medicinal Claims Advertising must not imply that food supplements can be used to prevent or treat illness or include any reference to such a property. Claims of this type are referred to as ‘medicinal claims’. It is acceptable, however, for advertisers to state that a product helps to support or maintain good health. Please remove all medicinal claims, including all references to medical conditions and symptoms. Examples ‘Helps reduce joint stiffness’ ‘Helps maintain supple and flexible joints’ ‘Helps prevent colds’ ‘Helps maintain a healthy immune system’ The following phrases are further examples of medicinal claims: ‘treatment’, ‘deficiency’, ‘prevention’, ‘spina bifida’, ‘joint stiffness’, ‘medical research’ etc. Please refer to MHRA’s ‘Guidance Note 8: A guide to what is a medicinal product’ for further guidance on medicinal claims. A link to the guidance note can be found in Appendix (1). Please note that disease risk reduction claims which have been authorised by the European Commission are permitted. Please see point 8 of the Checklist. (Why? Directive 2000/13/EC Article 2 (1b); Food Labelling Regulations 1996 (as amended); Schedule 6, CAP Code 15.6.2; BCAP Code 13.6.2.) 5. Tonic Claims Please remove any tonic claims such as ‘restores vitality’, ‘gives you a lift/boost’. Examples ‘A great pick-me-up’ ‘Helps maintain good health and wellbeing’ (refer to ‘6’ below) (Why? Food Labelling Regulations 1996 (as amended) Schedule 6.) 6. General Health and Wellbeing Claims If you have included a ‘general health and wellbeing’ claim such as ‘helps maintain good health and wellbeing’, you also need to include a specific health claim as provided for under Articles 13 and 14 (see notes above). (Why? NHCR Article 10 (3) ; CAP Code 15.2 ; BCAP Code 13.4.3.) 7. Energy Claims Please ensure that energy claims accurately reflect the role of the particular nutrient. Several vitamins and minerals can claim to help the body release energy from food, but it is unusual for food supplements to be a source of energy (calories), or to be able to support 14 claims that the product increases energy levels. (Why? ASA complaint adjudications; general misleadingness rules) 8. Disease Risk Reduction Claims Reduction of disease risk claims must be authorised by the European Commission prior to use. The claim must refer to the effects of a food/ingredient on a disease risk factor, not on the disease itself. For example, the following is an authorised claim ‘Plant sterols have been shown to reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’. It would not be acceptable to abbreviate this to: ‘Plant sterols have been shown to reduce the risk of developing coronary heart disease’. The latter would be viewed as a medicinal claim. Advertisers are reminded that products bearing disease risk factor reduction claims must include a statement that the disease has multiple risk factors and altering one of these factors may or may not have a beneficial effect. 9. Health Professional Endorsement The Nutrition and Health Claims Regulation prohibits the use of health claims that make reference to recommendations from individual health professionals. The Department of Health has recently tightened up its guidance relating to this part of the regulation. The guidance below reflects the Department of Health’s ‘Guidance to compliance with Regulation (EC) 1924/2006 on nutrition and health claims made on foods’, version 2, November 2011. 9a.) It is acceptable for health professionals to provide healthy eating or lifestyle advice as long as that advice is neither a direct nor indirect recommendation of the product or its ingredients. For example: ‘Jo Smith, Dietitian recommends eating five portions of fruit and vegetables per day and taking regular exercise’ would be acceptable for inclusion within an advertisement for a food supplement. ‘Jo Smith, Dietitian says that vitamin A is needed for normal vision’ would not be acceptable for inclusion within an advertisement for a food supplement containing vitamin A. ‘Jo Smith, Dietitian recommends Product X because it contains vitamin A which is needed for normal vision’ would not be acceptable. 9b.) In contrast, the claim ‘Jo Smith, Dietitian recommends Product X’ would be acceptable for use in an advertisement that does not include any health claims. Please note that this includes health claims that are visible on pack, claims that form part of a product name and visual representations of claims. 9c.) It is permissible to refer to research that has been carried out by a health professional as long as the wording used does not give an impression of health professional recommendation or endorsement and as long as the statement is in line with an authorised claim. For example: ‘Research conducted by Dr Smith and colleagues shows that calcium is necessary for 15 bone health’ is likely to be acceptable. ‘As a result of their research, Dr Smith recommends calcium for healthy bones’ would not be acceptable. (Why? NHCR Article 12 (c).) 10. Recommendations from International Associations of Medical, Nutrition and Dietetic Professionals Please remove any recommendations from international associations of medical, nutrition and dietetic professionals. Recommendations from national associations of medical, nutrition or dietetic professionals are permitted. For example: ‘The British Dietetic Association recommends X’ would be acceptable (assuming the relevant permissions were granted) as the BDA is a national association. ‘The International Association of Healthcare Professionals recommends X’ would not be acceptable as the association referred to is international. (Why? NHCR Article 12 (c).) 11. Recommendations from Health-Related Charities and Other Associations Recommendations from health-related charities and other associations are only acceptable where the implied health claim is based on an authorised Article 13 or Article 14 health claim. Please bear in mind that any implied claims must not be medicinal. For example: ‘The British Heart Foundation recommends X’ is likely to be acceptable where the relevant permissions have been granted, and where there is an authorised claim linking the consumption of X with a healthy heart. Neither the name ‘British Heart Foundation’, nor the work of the BHF, which includes promoting health maintenance through a healthy lifestyle, is likely to be viewed as an implied medicinal claim. ‘Arthritis Care recommends X’ is unlikely to be acceptable as this would be an implied medicinal claim. (Why? NHCR Articles 11 and 12.) 12. Product Recommendations of Charities and Donations to Charities and Other Associations Advertisers may state that they are donating money to, or that they support a particular charity. Where the partnership is purely for fundraising purposes, this must be made clear to consumers. Please bear in mind that any implied claims must be acceptable under the applicable regulations and codes. (Please also refer to ‘Charity Promotions’ in the CAP Code). 16 (Why? NHCR Articles 11 and 12.) 13. Celebrities Whilst it is generally acceptable to use celebrities in food supplement advertising, members should bear in mind that the CAP Code prohibits the use of licensed characters or celebrities popular with children in branded activities targeted directly at primary school or pre-school children. In addition, any claims made by celebrities must comply with authorised claims. Please contact PAGB for advice on which materials fall under the CAP Code. (Why? CAP Code 15.15.) 14. Comparisons The Nutrition and Health Claims Regulation includes complex requirements for comparisons. Comparative claims may only be made between foods of the same category, must compare the food with a range of foods in that category and must specify the difference in the quantity of the nutrient (and/or energy value as appropriate). Please refer to Article 9 of the Nutrition and Health Claims Regulation for further details. Comparative nutrition claims are only permitted where a comparison is made between the food in question and a range of foods of the same category. Claims such as ‘Supplement X contains as much calcium as a glass of milk’ are not permitted as these foods are not considered to be of the same category. (Why? NHCR Article 9.) 15. Nutrition Claims Nutrition claims are only permitted if they are listed in the Annex to the Nutrition and Health Claims Regulation. The wording of the claim is flexible. Companies may use alternative wording which is likely to have the same meaning for the consumer. When using nutrition claims, please ensure that the product complies with the conditions of use for those claims. A copy of the Annex to the Nutrition and Health Claims Regulation can be found in Appendix (5). A link to the on-line version can be found in Appendix 1. Please refer to the Nutrition Claims Approval Flowchart on page 23 Please refer to points 15 to 18 of the Checklist for guidance on nutrition claims relating to vitamins and minerals. (Why? NHCR Article 8 and the Annex to the NHCR.) Additional Requirements for Vitamin and Mineral Supplement Advertising 16. Sufficient Quantity in Order to Make Claims 17 In order to say that your product is a source of a particular vitamin or mineral, or in order to make any claims about a vitamin or mineral, the product must contain a significant amount of that vitamin or mineral. In general, ‘a significant amount’ is taken to mean at least 15% of the RDA. (Please refer to Appendix (2) for a list of the RDAs.) PAGB is willing to consider evidence which seeks to demonstrate that a product contains a significant amount in cases where the 15% rule is not met. (Why? Food Labelling Regulations 1996 (as amended) Schedule 6; and NHCR Annex; Food Information for Consumers Regulation Annex XIII Part A, point 2.) 17. ‘Source of Vitamins and Minerals’ or ‘Contains Vitamins and Minerals’ Under the Nutrition and Health Claims Regulation it is no longer acceptable to simply state that a product contains vitamins or minerals or that it is a source of vitamins or minerals. Where such claims are used they must be accompanied by a list of the vitamins and minerals contained in the product. Examples ‘Contains vitamins and minerals’ ‘Contains vitamins A, C and iron’ ‘Contains vitamins including: vitamin C, vitamin A and vitamin D’ ‘Contains vitamins and minerals* *vitamin A, C and iron’ (Why? NHCR Annex.) 18. ‘High In’ Claims In order to say that your product is ‘high in’ a particular vitamin or mineral, the product must contain twice the value of ‘a source of’ (see point 15). In most cases, this will be at least 30% of the RDA of that ingredient. (Why? NHCR Annex.) 19. ‘Complete’ Claims For many years, food supplement manufacturers have used the term ‘complete’ to communicate that that product contains a significant amount of each scheduled vitamin and mineral (i.e. each vitamin and mineral that has an RDA). However, ‘complete’ has not been included in the list of permitted nutrition claims in the Annex to the Nutrition and Health Claims Regulation. PAGB advises members that there is a risk associated with the use of ‘complete’ claims. In order to say that your product is ‘complete’ it should contain a significant amount of each vitamin and mineral that has an RDA. In general, ‘a significant amount’ is taken to mean at least 15% of the RDA. To say that your product is a ‘complete multivitamin’ it should contain a significant amount of each vitamin for which an RDA is set; and in order to say that the product is a ‘complete multimineral’ the product should contain a significant amount of each mineral for which an RDA is set. A table of the RDAs with 15% and 30% calculated can be found in Appendix 2. 18 In the past, LACORS2 provided the following advice: “The term ‘complete’ without further explanation could be understood by the consumer to mean 100% rather than 15% of the RDA. To clarify the position it may be preferable to refer to these products as ‘Complete source of…’rather than just ‘Complete’’. The Better Regulation Delivery Office (BDRO), which has responsibility for the co-ordination of regulators, has not yet issued any advice to industry on labeling issues nor is it yet clear if it intends to do so. PAGB is of the opinion that the above qualifications are not necessary where the full nutrition information is provided, such as ‘complete claims’ used on pack, or on the company’s own website. Please bear in mind that since 31 October 2012 ‘complete claims’ need to comply with the revised list of RDAs. Please refer to Appendix (2) for a list of the RDAs. (Why? Industry agreed position.) 20. Health Claims - Flexibility of Wording The European Commission has stated that some flexibility of wording is possible provided that its aim is to help consumer understanding and that the amended wording has the same meaning to the consumer as the original claim. Both the Commission and the Department of Health have advised that claims should remain as close to the authorised wording as possible. The Department of Health has recently issued guidance on this issue and has stressed that claims that do not stick to the authorised wording must ensure that they do not exaggerate and can show the same relationship between the food for which a claim is made, and and the claimed health effect. The table overleaf includes some examples of wording commonly used in authorised Article 13 and Article 14 claims, together with some suggestions as to alternative wording. Please note that these are PAGB’s suggestions based on the information currently available. The list is intended as a guide only. It is not exhaustive and each claim must be assessed on a case-by-case basis. The examples listed may change as a result of guidance from the Department of Health or from the Commission, together with advertising adjudications/enforcement action. 2 LACORS (Local Authorities Coordinators of Regulatory Services) was the local government central body responsible for overseeing local authority regulatory and related services. Responsiblitiy for co-ordination of regulators now rests with the Better Regulation Delivery Office (BDRO). 19 Health Claims - Flexibility of Wording Examples Commonly Used Wording in Authorised Health Claims Potential Alternative Wording ‘contributes to…’ ‘helps support…’ ‘is used in…’ ‘assists in…’ ‘helps in…’ ‘plays a role in…’ (Please note, if the authorised wording is ‘contributes to the normal...’ then the alternative wording must not imply an improvement.) ‘contributes to the maintenance of…’ ‘helps maintain…’ ‘helps support…’ ‘has a role in…’ ‘is needed for…’ ‘is required for…’ ‘is used in…’ ‘contributes to…’ ‘helps support…’ ‘is needed for…’ ‘is required for…’ ‘is used in…’ ‘contributes to…’ ‘helps support…’ 20 5. Evidence Checklist Please also refer to the Approval Flowchart for ‘On-hold’ Health Claims on page 22 The majority of health claims relating to vitamins, minerals and other nutrients submitted for assessment have been evaluated and either authorised or rejected. There remain a number of outstanding claims for “botanicals” awaiting EFSA assessment; these can continue to be used if they can provide the kind of evidence discussed below. 21. Has the claim been authorised by the European Commission or received a favourable opinion from EFSA? If the answer to either of these questions is ‘yes’, you do not need to submit evidence to PAGB. If the answer to either of these questions is “no” please consider the following: Is the claim made against a substance which has received a negative opinion from EFSA and has not been authorised for use in the European Union? o If this is the case you cannot use the claim Is the claim made against a “botanical” which are currently on hold whilst the European Commission considers how to evaluate the claims? o If yes, please see below 22. Have you already submitted evidence to PAGB for this claim? If you have already submitted evidence to PAGB in support of this claim, and have used the claim before, PAGB is unlikely to request evidence. PAGB will request further evidence if it is needed. Please bear in mind that member companies are responsible for ensuring that they have appropriate evidence for the claims they make in advertising. 23. If this is a new claim, please submit evidence. The following evidence is likely to be acceptable: studies carried out in healthy humans references to reputable nutrition text books references to the Department of Health, NHS or British Nutrition Foundation websites. The following evidence is unlikely to be acceptable: studies carried out on animals, in vitro, or in humans with existing pathology if this is the only evidence you have references to websites and nutrition books not based on generally accepted science results from poorly conducted trials. PAGB will also consider factors such as: is the dosage similar to your product? is the study design robust e.g. was there a control group, was the study ‘blind’, was the sample size sufficient, did it take account of confounding factors? were the participants from a similar target group to those who you expect to purchase your product? NB. You will also need to consider whether there are other studies whose results contradict the proposed claim. 21 How to Submit Evidence Please provide a summary document explaining why you believe that the claim is supportable. This is particularly important where there are several pieces of evidence to support a particular claim; where not all of the evidence is in humans; where the dosage used in the study is higher than that used in your product; where some of the evidence is conflicting and/or or where some of the evidence is in people with existing pathology. 24. Regulatory/ Medical Department Sign-Off Having checked the claims and evidence, please make sure that your regulatory/medical department are happy with the advertisement, before submitting to PAGB. Please bear in mind that this checklist is intended as a reminder and does not include all aspects which may require consideration 22 PAGB Advertising Approval Flowchart for ‘On-hold’ Health Claims Has a dossier for the claim been submitted and is awaiting assessment by the European Food Safety Authority? Not sure Refer to the Community Register of Health Claims and the EFSA opinions. See Appendix 1 for links. Yes Have you submitted data to PAGB? - and Has the claim recently been approved by PAGB? Yes You do not need to submit evidence to PAGB at this stage. PAGB will request further evidence if needed. No Please submit data*. (Please refer to point 20 of the Checklist for guidance.) PAGB is unable to approve the claim. The claim may be used until the claim has been evaluated by EFSA and either approved or rejected by the EU Commission and throughout any transition arrangements relating to the claim. The claim is subsequently approved by PAGB (Transition periods vary depending on the type of claim, see Appendix 3 and Article 28 of the Regulation for details.) The claim is not acceptable for use in advertising or packaging. * Please note that Article 14 Children’s claims may only be used if the claim was in use before 19 Jan 2007 and an application for authorisation has been submitted to EFSA. Article 14 Disease Risk Reduction claims cannot be used unless they have been authorised by the Commission and are included on the Register The Register of questions for Article 13.1 claims is a useful resource for checking the status of claims http://registerofquestions.efsa.europa.eu/roqFrontend/questionsListLoader?panel=NDA&foods ectorarea=26 23 Approval Flowchart – Nutrition Claims Is the nutrition claim listed in the Community Register of Nutrition and Health Claims Regulation? Yes No The claim may be used: The claim is not permitted for use in advertising or packaging. as long as the conditions for use are complied with (refer to the Community Register of Nutrition and Health Claims Regulation or see Appendix 1 for a link to the permitted nutrition claims) the wording is flexible as long as the claim is likely to have the same meaning for the consumer. 24 Appendix 1: Important Links Member companies and their agents are responsible for ensuring they are fully acquainted with, and conform to, the legal and self-regulatory requirements in force at any time. Since such requirements are continually evolving, it is not possible to provide a definitive list of the relevant statutory instruments and accompanying guidance. However, the principal legal requirements are given below. Community Register of Nutrition and Health Claims Made on Foods Permitted nutrition claims as listed in the Community Register of Nutrition and Health Claims Regulation http://ec.europa.eu/food/food/labellingnutrition/claims/ community_register/nutrition_claims_en.htm Authorised and Rejected Health Claims http://ec.europa.eu/nuhclaims EFSA’s Opinions on Health Claims To access opinions select: Panel/Unit: ‘NDA’ Scientific Output :’Opinion of the Panel/Scientific Committee’ Sub Category: ‘Article 13, 13.5 or 14’ http://www.efsa.europa.eu/en/scdocs.htm Guidance Documents Nutrition and health claims: Guidance to compliance with Regulation (EC) 1924/2006 on nutrition and health claims made on foods https://www.gov.uk/government/uploads/system/uplo ads/attachment_data/file/151864/dh_131531.pdf.pdf MHRA Guidance Note 8: A guide to what is a medicinal product http://www.mhra.gov.uk/home/groups/islic/documents/publication/con007544.pdf EU Commission guidelines for the implementation of specific conditions for health claims laid down in Article 10 of Regulation (EC) No 1924/2006 http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2 013:022:0025:0028:EN:PDF General Principles on flexibility of wording for health claims https://www.gov.uk/government/uploads/system/uplo ads/attachment_data/file/156287/health-claimsflexibility-of-wording-principles-UK-19-Dec2012.pdf.pdf Codes of Practice The UK Code of Non-Broadcast Advertising, Sales Promotion and Direct Marketing (the CAP Code) http://www.cap.org.uk/AdvertisingCodes/~/media/Files/CAP/Codes%20CAP%20pdf/C AP%20Code%200712.ashx The UK Code of Broadcast Advertising (the BCAP Code) http://www.cap.org.uk/The-Codes/BCAP-Code.aspx Ofcom Broadcasting Code http://www.ofcom.org.uk/tv/ifi/codes/bcode 25 26 Legislation Regulation (EC) No 1924/2006 of the European Parliament and of the Council of the European Union on nutrition and health claims made on food (as amended) http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri =CONSLEG:2006R1924:20080304:EN:PDF Regulation (EC) No 353/2008 of the European Parliament and of the Council of the European Union establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 (as amended) http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri =OJ:L:2008:109:0011:0016:EN:PDF COMMISSION REGULATION (EU) No 432/2012 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 http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2 012:136:0001:0040:EN:PDF SI No. 1387, The Food Supplements (England) Regulations 2003 http://www.legislation.gov.uk/uksi/2003/1387/content s/made Directive 2000/13/EC on the presentation and advertising of foodstuffs http://eur-lex.europa.eu/pri/en/oj/dat/2000/ l_109/l_10920000506en00290042.pdf SI No. 2824, Food Labelling Regulations (Amendment) (England) (No.2) Regulations 2004 http://www.legislation.gov.uk/uksi/2004/2824/made SI No. 1499 The Food Labelling Regulations 1996 http://www.legislation.gov.uk/uksi/1996/1499/content s/made Directive 2008/100/EC on nutrition labelling for foodstuffs as regards Recommended daily allowances, energy conversion factors and definitions http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2 008:285:0009:0012:EN:PDF Consumer Protection from Unfair Trading Regulations 2008 http://www.legislation.gov.uk/uksi/2008/1277/content s/made Regulation (EC) No 608/2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters http://eur-lex.europa.eu/LexUriServ/site/en/oj/2004/ l_097/l_09720040401en00440045.pdf Regulation (EC) No1170/2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 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 http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2 009:314:0036:0042:EN:PDF The Food Supplements (England) and Addition of Vitamins, Minerals and Other Substances (England) (Amendment) Regulations 2009 27 http://www.legislation.gov.uk/uksi/2009/3251/content s/made Appendix 2: Recommended Daily Allowances Recommended Daily Allowances (RDAs) The RDAs as listed in the Food Labelling Regulations, 1996 were updated in 2008. The list below is taken from Commission Directive 2008/100/EC. All materials must comply with the revised RDAs as of 31 October 2012. 15% RDA ‘Significant Amount’ 30% RDA ‘High’ Nutrient RDA Vitamin A (μg) 800 120 240 Vitamin D (μg) 5 0.75 1.5 Vitamin E (mg) 12 1.8 3.6 Vitamin K (μg) 75 11.25 22.5 Vitamin C (mg) 80 12 24 Thiamin (mg) 1.1 0.165 0.33 Riboflavin (mg) 1.4 0.21 0.42 Niacin (mg) 16 2.4 4.8 Vitamin B6 (mg) 1.4 0.21 0.42 Folic acid (μg) 200 30 60 Vitamin B12 (μg) 2.5 0.375 0.75 Biotin (μg) 50 7.5 15 Pantothenic acid (mg) 6 0.9 1.8 Potassium (mg) Chloride (mg) 2000 800 300 600 120 240 Calcium (mg) 800 120 240 Phosphorus (mg) 700 105 210 Magnesium (mg) 375 56.25 112.5 Iron (mg) 14 2.1 4.2 Zinc (mg) 10 1.5 3 Copper (mg) 1 0.15 0.3 Manganese (mg) 2 0.3 0.6 Fluoride (mg) 3.5 0.525 1.05 Selenium (μg) 55 8.25 16.5 Chromium (μg) 40 6 12 Molybdenum (μg) 50 7.5 15 Iodine (μg) 150 22.5 45 28 Appendix 3: Transitional Arrangements for Health Claims The Nutrition and Health Claims Regulation defines health claims 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’. The Community Register of Health Claims has been published; advertisers may make the health claims included in that Register which are listed as “Authorised” (although the exact wording will be flexible). There are some additional claims for botanicals which can continue to be used under extended transitional arrangements. The different types of health claim are described in Articles 13 and 14 of the Regulation. Article 13 Health Claims Article 13 refers to three categories of health claims: 1a. the role of a nutrient or other substance in the growth, development and the functions of the body (e.g. ‘calcium and vitamin D are needed for the maintenance of normal bone’) 1b. psychological and behavioural functions (e.g. ‘helps with concentration’) 1c. slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or a reduction in the available energy from the diet (e.g. ‘helps you to feel full for longer’) Article 14 Health Claims Article 14 refers to two categories of health claims: 1. reduction of disease risk (e.g. ‘plant sterols have been shown to reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’). Advertisers are reminded that products bearing such claims must include a statement that the disease has multiple risk factors and altering one of these factors may or may not have a beneficial effect 2. claims referring to children’s development and health (e.g. ‘calcium and vitamin D are needed for normal growth and development of bone in children’). Transition Arrangements At the time of writing, the authorisation of claims is work in progress. Article 28 of the Nutrition and Health Claims Regulation sets out the transitional arrangements for the different types of claims. The Commission will adopt Article 13.1 claims in two stages. Stage 1 includes vitamins, minerals and other substances (excluding botanicals). Stage 2 will be botanicals. EFSA has now completed the assessment of the Stage 1 claims and these were adopted in May 2012 under Regulation 432/2012. The statutory requirements of Regulation 1924/2006 mean that transition time for claims that were not authorised under Regulation 432/2012 expired on 14 December 2012 and can therefore no longer be used. Companies are advised to liaise with their home authorities on this point as they are the enforcement bodies for this provision. The next page summarises the relevant transitional arrangements as set out in Article 28. 29 Summary of Transition Periods Type of Claim Current Situation Transition Period for Claims not included on the Community Register Article 13 1a. the role of a nutrient or other substance in the growth. development and the functions of the body e.g. ‘vitamin C contributes to the normal function of the immune system’ 1b. psychological and behavioural functions e.g. ‘helps with concentration’ 1c. slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or a reduction in the available energy from the diet e.g. ‘helps you to feel full for longer’ Most claims for vitamins and minerals have been evaluated and either authorised or rejected; rejected claims cannot be used. All authorised and non-authorised claims are now held on the Community Register of Nutrition and Health Claims. N/A N/A ‘Botanical claims “on hold” awaiting a determination by the Commission may continue to be used. If they are rejected and are not authorised there will be a six month transition period during N/A which these claims will need to be phased out. Article 14 1. reduction of disease risk e.g. ‘plant sterols have been shown to reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’ Claims must be authorised by the European Commission prior to use. N/A (these are new claims which have not previously been on the market) 2. claims referring to children’s development and health e.g. ‘essential fats are needed for the normal growth and development of children’ Claims may only be used if the claim was in use before 19/01/07 and an application for authorisation has been submitted. Six months from the date of adoption 30 Appendix 4: Children’s Claims - Article 13 or Article 14? On reading the Regulation it is apparent that there is an overlap between the Article 13 (1a) claims which describe or refer to ‘the role of a nutrient or other substance in growth, development and the functions of the body’ and Article 14 claims which refer to children’s development and health. In October 2007 the standing Committee on the Food Chain and Animal Health published guidance on the implementation of the Nutrition and Health Claims Regulation. The guidance stated ‘…only health claims solely referring to the development and health of children and where the scientific substation is only valid for children should be considered as Article 14 claims.’ It follows that all claims for which the substantiation applies to both adults and children are considered to be Article 13 regardless of whether the product is primarily aimed at adults or children. The table below is designed to be a helpful reminder as to when a claim is likely to be viewed as ‘Article 13’ or ‘Article 14’. Type of Claim Article 13 or 14? Substantiation applies equally to adults and children e.g. ‘calcium and vitamin D are needed for the maintenance of normal bone’. Article 13 Health claims solely referring to the development and health of children and where the scientific substantiation is only valid for children e.g. ‘calcium and vitamin D are needed for the normal growth and development of bone in children’. Article 14 Claims referring to an unborn baby Article 14 The product is primarily aimed at children such as a ‘Multivitamin for Children’. Claims may fall under Article 13 or 14. Each claim must be looked at individually The product is solely intended for children such as follow on formula and baby foods. Article 14 31 Appendix 5: Permitted Nutrition Claims Nutrition Claims and the Conditions Applying to Them as listed on the Community Register of Nutrition and Health Claims Low Energy A claim that a food is low in energy and any claim likely to have the same meaning for the consumer may only be made where the product does not contain more than 40 kcal (170 kJ)/100 g for solids or more than 20 kcal (80 kJ)/100 ml for liquids. For table-top sweeteners the limit of 4 kcal (17 kJ)/portion with equivalent sweetening properties to 6 g of sucrose (approximately 1 teaspoon of sucrose) applies. Energy-Reduced A claim that a food is energy-reduced and any claim likely to have the same meaning for the consumer may only be made where the energy value is reduced by at least 30% with an indication of the characteristic(s) which make(s) the food reduced in its total energy value. Energy-Free A claim that a food is energy-free and any claim likely to have the same meaning for the consumer may only be made where the product does not contain more than 4 kcal (17 kJ)/100 ml. For table-top sweeteners the limit of 0.4 kcal (1.7kJ)/portion with equivalent sweetening properties to 6 g of sucrose (approximately 1 teaspoon of sucrose) applies. Low Fat A claim that a food is low in fat and any claim likely to have the same meaning for the consumer may only be made where the product contains no more than 3 g of fat per 100 g for solids or 1.5 g of fat per 100 ml for liquids (1.8 g of fat per 100 ml for semi-skimmed milk). Fat-Free A claim that a food is fat-free and any claim likely to have the same meaning for the consumer may only be made where the product contains no more than 0.5 g of fat per 100 g or 100 ml. However claims expressed as ‘X% fat-free’ shall be prohibited. Low Saturated Fat A claim that a food is low in saturated fat and any claim likely to have the same meaning for the consumer may only be made if the sum of saturated fatty acids and trans-fatty acids in the product does not exceed 1.5 g per 100 g for solids or 0.75 g/100 ml for liquids and in either case the sum of saturated fatty acids and trans-fatty acids must not provide more than 10% of energy. Saturated Fat-Free A claim that a food does not contain saturated fat and any claim likely to have the same meaning for the consumer may only be made where the sum of saturated fat and trans-fatty acids does not exceed 0.1 g of saturated fat per 100 g or 100 ml. 32 Low Sugars A claim that a food is low in sugars and any claim likely to have the same meaning for the consumer may only be made where the product contains no more than 5 g of sugars per 100 g for solids or 2.5 g of sugars per 100 ml for liquids. Sugars-Free A claim that a food is sugars-free and any claim likely to have the same meaning for the consumer may only be made where the product contains no more than 0.5 g of sugars per 100 g or 100 ml. With No Added Sugars A claim stating that sugars have not been added to a food and any claim likely to have the same meaning for the consumer may only be made where the product does not contain any added mono- or disaccharides or any other food used for its sweetening properties. If sugars are naturally present in the food the following indication should also appear on the label: ‘CONTAINS NATURALLY OCCURRING SUGARS’. Low Sodium/Salt A claim that a food is low in sodium/salt and any claim likely to have the same meaning for the consumer may only be made where the product contains no more than 0.12 g of sodium or the equivalent value for salt per 100 g or per 100 ml. For waters other than natural mineral waters falling within the scope of Directive 80/777/EEC this value should not exceed 2 mg of sodium per 100 ml. Very Low Sodium/Salt A claim that a food is very low in sodium/salt and any claim likely to have the same meaning for the consumer may only be made where the product contains no more than 0.04 g of sodium or the equivalent value for salt per 100 g or per 100 ml. This claim shall not be used for natural mineral waters and other waters. Sodium-Free or Salt-Free A claim that a food is sodium-free or salt-free and any claim likely to have the same meaning for the consumer may only be made where the product contains no more than 0.005 g of sodium or the equivalent value for salt per 100 g. Source of Fibre A claim that a food is a source of fibre and any claim likely to have the same meaning for the consumer may only be made where the product contains at least 3 g of fibre per 100 g or at least 1.5 g of fibre per 100 kcal. High Fibre A claim that a food is high in fibre and any claim likely to have the same meaning for the consumer may only be made where the product contains at least 6 g of fibre per 100 g or at least 3 g of fibre per 100 (kcal. 33 Source of Protein A claim that a food is a source of protein and any claim likely to have the same meaning for the consumer may only be made where at least 12% of the energy value of the food is provided by protein. High Protein A claim that a food is high in protein and any claim likely to have the same meaning for the consumer may only be made where at least 20% of the energy value of the food is provided by protein. Source of [Name of Vitamin/s] and/or [Name of Mineral/s] A claim that a food is a source of vitamins and/or minerals and any claim likely to have the same meaning for the consumer may only be made where the product contains at least a significant amount as defined in the Annex to Directive 90/496/EEC or an amount provided for by derogations granted according to Article 6 of Regulation (EC) No 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. High [Name of Vitamin/s] and/or [Name of Mineral/s] A claim that a food is high in vitamins and/or minerals and any claim likely to have the same meaning for the consumer may only be made where the product contains at least twice the value of ‘source of [NAME OF VITAMIN/S] and/or [NAME OF MINERAL/S]’. Contains [Name of the Nutrient or Other Substance] A claim that a food contains a nutrient or another substance for which specific conditions are not laid down in this Regulation or any claim likely to have the same meaning for the consumer may only be made where the product complies with all the applicable provisions of this Regulation and in particular Article 5. For vitamins and minerals the conditions of the claim ‘source of’ shall apply. Increased [Name of the Nutrient] A claim stating that the content in one or more nutrients other than vitamins and minerals has been increased and any claim likely to have the same meaning for the consumer may only be made where the product meets the conditions for the claim ‘source of’ and the increase in content is at least 30% compared to a similar product. Reduced [Name of the Nutrient] A claim stating that the content in one or more nutrients has been reduced. and any claim likely to have the same meaning for the consumer may only be made where the reduction in content is at least 30% compared to a similar product except for micronutrients where a 10% difference in the reference values as set in Directive 90/496/EEC shall be acceptable and for sodium or the equivalent value for salt where a 25% difference shall be acceptable. 34 Light/Lite A claim stating that a product is ‘light’ or ‘lite’ and any claim likely to have the same meaning for the consumer. shall follow the same conditions as those set for the term ‘reduced’; the claim shall also be accompanied by an indication of the characteristic(s) which make(s) the food ‘light’ or ‘lite’. Naturally/Natural Where a food naturally meets the condition(s) laid down in this Annex for the use of a nutritional claim the term ‘naturally/ natural’ may be used as a prefix to the claim. Source of Omega-3 Fatty Acids A claim that a food is a source of omega-3 fatty acids and any claim likely to have the same meaning for the consumer may only be made where the product contains at least 0.3 g alphalinolenic acid per 100 g and per 100 kcal or at least 40 mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100 g and per 100 kcal. High Omega-3 Fatty Acids A claim that a food is high in omega-3 fatty acids and any claim likely to have the same meaning for the consumer may only be made where the product contains at least 0.6 g alphalinolenic acid per 100 g and per 100 kcal or at least 80 mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100 g and per 100 kcal. High Monounsaturated Fat A claim that a food is high in monounsaturated fat and any claim likely to have the same meaning for the consumer may only be made where at least 45% of the fatty acids present in the product derive from monounsaturated fat under the condition that monounsaturated fat provides more than 20% of energy of the product. High Polyunsaturated Fat A claim that a food is high in polyunsaturated fat and any claim likely to have the same meaning for the consumer may only be made where at least 45% of the fatty acids present in the product derive from polyunsaturated fat under the condition that polyunsaturated fat provides more than 20% of energy of the product. High Unsaturated Fat A claim that a food is high in unsaturated fat and any claim likely to have the same meaning for the consumer may only be made where at least 70% of the fatty acids present in the product derive from unsaturated fat under the condition that unsaturated fat provides more than 20% of energy of the product.’ 35 Appendix 6: Quick Assessment Chart - Claims Does the material include medicinal claims? Does the material include tonic claims? Does the material suggest that it is difficult to get what you need from a varied diet? Does the material include any health claims which make reference to recommendations from individual health professionals including celebrity health professionals? Does the material include any recommendations from international associations of medical, nutrition or dietetic professionals? Does the material include nutrition claims? They must comply with the Annex to the NHCR. If the material includes a general health and wellbeing claim it must also include a specific claim. Claims should be understood by the average consumer. Energy claims must accurately reflect the role of the nutrient(s). Does the material include recommendations from health-related charities? Implied claims must be acceptable and not imply a medicinal benefit. Use of celebrities is permitted unless targeted directly at young children. Ask PAGB for advice. Does the material include any comparisons or as much as claims? These are only permitted for foods in the same category. To claim ‘source of’ a vitamin or mineral or to make any claim about a vitamin or mineral, the product must contain a significant amount which is generally taken to mean at least 15% of the RDA. To claim ‘high in’ a vitamin or mineral the product must contain at least twice the amount of ‘source of’ which is generally taken to be 30% RDA. To claim ‘complete’, the product must contain ‘a source of’ (generally taken to mean at least 15% of the RDA) each vitamin and mineral. CLAIMS NOTES Claims Not Permitted Conditional Claims 36 Appendix 7: Organisations Involved in the Self-Regulation of Food Supplements Advertising in the UK The roles of the self-regulatory organisations involved in the control of food supplements advertising are described below. The Advertising Standards Authority (ASA) is a complaints body and therefore the sanctions used by ASA have also been listed. The Committee of Advertising Practice (CAP) and the Advertising Standards Authority (ASA) The Committee of Advertising Practice is the industry body responsible for the UK’s advertising codes. Its non-broadcast Committee, CAP, writes and enforces the UK Code of Non- broadcast Advertising, Sales Promotion and Direct Marketing (the CAP Code) which applies to nonbroadcast advertising. The Committee comprises representatives of advertisers, agencies, media owners and other industry groups (including PAGB), all of which are committed to upholding the highest standards in advertising. CAP offers a free, pre-publication copy-advice service. The CAP Code does not apply to health claims in materials aimed at health professionals. Since 1 March, 2011, the CAP Code has also applied to: ‘Advertisements and other marketing communications by or from companies on their own websites, or in other non-paid-for space online under their control, that are directly connected with the supply or transfer of goods, services, opportunities and gifts, or which consist of direct solicitations of donations as part of their own fund-raising activities.’ This includes material on companies’ own websites and activities on social networking sites, such as Facebook and Twitter, where those activities are intended to promote products or brands. For further information please refer to www.cap.org.uk or contact advice@cap.org.uk. CAP’s Broadcast Committee is contracted by the broadcast regulator, Ofcom, to write and enforce the code of practice that governs television and radio advertising, the UK Code of Broadcast Advertising (the BCAP Code) and the Advertising Standards Code for Text Services. The Broadcast Committee of Advertising Practice, BCAP, comprises representatives of broadcasters licensed by Ofcom, advertisers, agencies and direct marketers. The ASA is the independent body that is responsible for ensuring that the system operates in the public interest. Each year the ASA receives approximately 25,000 complaints about UK advertisements. Complaints are assessed against the CAP Code, the UK Code of Broadcast Advertising, or the Advertising Standards Code for Text Services, as applicable. ASA Sanctions If a complaint is upheld, ASA asks the advertiser to withdraw or amend the advertising. Broadcasters are obliged, by a condition of their Ofcom licences, to enforce ASA rulings and not to run advertisements that have been found to breach the codes. Similarly, if non-broadcast advertisers do not comply with adjudications, CAP can issue an ‘Ad Alert’. Ad Alerts ask those responsible for accepting ads for publication to consult CAP’s Copy Advice team before accepting any ads from the advertiser named in the alert. If advertisers do not co-operate with the self-regulatory system, ASA can refer the advertiser to the Office of Fair Trading. New sanctions will be introduced to strengthen CAP’s ability to secure compliance on websites and other non-paid-for space online under the advertiser’s control. Please refer to www.cap.org.uk for details. 37 ASA publishes adjudications on investigated complaints each week on its website (www.asa.org.uk). This generates a high volume of adverse publicity for advertisers who breach the codes. Advertisements that break the codes are disqualified from industry awards, denying them and the agencies that created the ads the opportunity to showcase their work. Advertisers and agencies that persistently breach the Code jeopardise their membership of trade organisations. In exceptional circumstances, an advertiser may apply to have an ASA adjudication reviewed if new evidence can be provided in defence of claims or if the advertiser can demonstrate a significant flaw in the adjudication or in the decision process. Ofcom Ofcom is a statutory body set up under the Communications Act 2003. Amongst a broad range of roles as communications regulator, Ofcom must ensure that the content of programmes and advertising on television and radio meets appropriate standards. Ofcom has contracted out the regulation of broadcast advertising to ASA and BCAP. Ofcom has retained responsibility for sponsorship on television and radio. The sponsorship rules can be found in the Ofcom Broadcasting Code. Clearcast Clearcast is the company responsible for the pre-transmission examination and pre-clearance of television advertisements. As part of their licensing agreements with Ofcom, broadcasters are required to ensure that the advertising they broadcast is not misleading or harmful to viewers. Broadcasters choose to do this by pre-clearing advertising before it is broadcast. Clearcast is owned and funded by six broadcasters all of whom are represented on Clearcast’s Board and all of whom use Clearcast for clearing advertising. Other broadcasters using Clearcast for clearance pay individually for the service. Advertising is cleared in accordance with the UK Code of Broadcast Advertising. PAGB member companies are required to submit television advertising material to both Clearcast and PAGB. Clearcast has access to independent medical and nutrition advisers. Radio Advertising Clearance Centre (RACC) RACC is the self-regulatory body responsible for pre-vetting certain categories of radio advertising. It answers to the ASA as the broadcast media regulator. It translates practically the requirements of the UK Code of Broadcast Advertising and is administered by commercial radio’s trade body, RadioCentre, whose members fund its services. (Delete Radio advertising must be cleared by RACC before transmission). PAGB member companies are required to submit radio advertising materials to both RACC and PAGB. RACC has access to independent medical and nutrition advisers. Cinema Advertising Association (CAA) The primary function of CAA is to promote, monitor and maintain standards of cinema advertising. This includes pre-vetting all cinema commercials to ensure conformity with the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (the CAP Code). CAA Copy Panel clears commercials for exhibition in cinemas in the UK and the Republic of Ireland. No commercial may be exhibited in a cinema unless it has been cleared by CAA. 38