Recent Developments in Regulation of Nutrition and Health Claims

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1 Recent Developments in Regulation of Nutrition and Health Claims Craig Simpson, Lawyer June 19, 2012

2 Outline NHCR v. practical implementation Claims geography and interpretation issues Life post Regulation 432/2012 (permitted claims list)? 2

3 Disparity between NHCR v. practice Departure from NHCR requirements, or justifiable interpretation? Worrying precedent not only example in EU legislation Text of Regulation gospel or approximate indication? Consistency with general principles of EU law? legal certainty, legitimate expectation "those who act in good faith on the basis of law as it is or seems to be should not be frustrated in their expectations". legal challenge? Water Claim precedent (T-17/12) 3

4 NHCR v. practice: understood by average consumer Law Article 5(2): claims permitted only if the average consumer can be expected to understand the beneficial effects Article 13(1) function health claims may be made without undergoing the procedures laid down in Articles 15 to 19, if they are well understood by the average consumer Reality Pantothenic acid contributes to normal synthesis and metabolism of steroid hormones, vitamin D and some neurotransmitters (Regulation 432/2012) Wording flexibility, but same meaning Purpose of claim to educate consumer? Inconsistent presumption of sophistication of average consumer 4

5 NHCR v. practice: risk factor statement Law Reality Article 2(6): reduction of disease risk claim means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease Commission Regulation 1170/2011, Recital (6): as a risk factor in the development of a disease is not shown to be reduced, the claim does not comply with the requirements of Regulation 1924/2006 and it should not be authorised Commission examples not mentioning risk factor calcium helps reduce the risk of osteoporosis 5

6 NHCR v. practice: scientific substantiation Law Reality Recital (26): Health claims, based on generally accepted scientific evidence, should undergo a different type of assessment and authorisation. Recital (23): health claims should only be authorised for use after a scientific assessment of the highest possible standard. Article 13(1) function claims may be made without undergoing the procedures laid down in Articles 15 to 19, if they are based on generally accepted scientific evidence. The classification [between Article 13 and 14 claims] has no impact on the level of substantiation needed for the authorisation (Guidance, SCFCAH Conclusions 2007). EU Ombudsman Case: 1951/2011/DK Commission adoption of permitted claims list = incorrect application of substantive rules of NHCR (ECGAB Article 4 breach)? Proportionality? 6

7 NHCR v. practice: nutrient profiles Law Reality Article 4(1): Commission to establish nutrient profiles by 19 January and a half years later? (plus 2 year transitional period) European Commission NHC Working Group, March 2012: Commission to restart discussions after adoption of permitted list (now) Still scientifically credible? [Nutrient profiles may] also take account of non-scientific elements, such as the capacity of the food industry to innovate (6 September 2010, Commissioner Dalli Answer to EP Questions E-5939/10) 7

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9 Article 13 options post permitted list: checklist Regulation 432/2012 list of 222 Article 13 permitted function health claims adopted 16 May 2012 applicable from 14 December 2012 Your claim is on Regulation 432/2012 Annex list? may use in accordance with specific conditions post 14 December 2012 Your claim has same meaning for consumers as that of permitted health claim (Recital (9) Regulation 432/2012)? may use in accordance with specific conditions post 14 December 2012 within discretion of national authorities = single market? to accommodate linguistic, cultural factors but not misleading (Commission Q&A on Regulation 432/2012) 9

10 Article 13 options post permitted list: checklist list of claims whose evaluation by EFSA or consideration by Commission not yet completed (botanicals, microorganisms, etc.)? may continue to be used according to transitional periods Commission NHC Working Group, 21 May: SCFCAH discussion of on holds, except botanicals, end 2012 None of the above/ EU Register rejected list ( use prohibited from 14 December 2012 relabelling programme now! 10

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12 Article 13: existing/pending Article 13(5) claim? Benefit from generic nature of individual claims already authorised by others (Article 17(5) NHCR) wording flexibility expressly permitted under individual authorisations Claims in process register gprocessed is another party already applying? 5 year exclusivity for proprietary data? (check dedicated EU Register Annex) licence from prior applicant to refer to data in own application can use own data to authorise same claim (Recital (4), Regulation 107/2008) 12

13 Article 13: existing/pending Article 13(5) claim? Contrast with other EU data protection regimes (biocidal products, REACH): only 5 years (not 10/12), despite pharma level studies (RCTs) data sharing not mandatory (not principally animal testing) no equivalent of REACH FRAND data sharing costs requirement competition law underlying FRAND for example, all or nothing tying, discrimination in licence fees, excessive pricing Data protection not permitted for studies in the public domain? (Decision 2009/980) publication legal right to refer publication with or without prior request for protection 13

14 Article 13 options: individual authorisation Commit to apply for authorisation under Article 13(5) resources (3 clinical trials = EUR 500,000), delay justified? Consider reason for rejection (see EU Register): cause and effect not substantiated by studies claimed effect of nutrient/substance/food not sufficiently defined no health benefit found inconsistent with generally accepted nutrition and health principles (Recital (12) Regulation 432/2012) sodium is needed for the functioning of muscles not authorised despite cause and effect established by EFSA because use would convey a conflicting and confusing message to consumers by encouraging consumption of nutrients which intake should be reduced. Article 3(a) NHCR legal basis ( false, ambiguous or misleading ) convincing? 14

15 Article 13 options: less ambitious claim Can you live with a less ambitious claim compatible with product positioning? Nutrition claim listed in Annex of Regulation, or any claim likely to have the same meaning for the consumer (Annex of Regulation) Defensible argument that outside scope of nutrition or health claims assess commercial risk/enforcement exposure/prepared to defend in court feasible? Pre-2005 brand names/trade marks ( Healthy Choice ) Change product positioning so can use permitted claim or avoid scope of NHCR (PARNUTS)? 15

16 Transitional periods Article 28 of Regulation not user friendly only data protection provisions worse! Different periods depending on type of claim 2 questions: can you use claim prior to authorisation/non-authorisation decision? phase-out period post non-authorisation decision? growth development and functions of the body (Article 13(1)(a)) claims which comply with Regulation and applicable national provisions: can continue to be used until adoption of permitted list (Article 28(5)) non-authorised/non-listed claims can continue to be used until six months after entry into force of permitted list (Regulation 432/2012), i.e. until 14 December

17 Transitional periods psychological, behavioural, slimming, weight control (Article 13(1)(b) and (c)) and children s development and health claims (Article 14(1)(b): legally used under national provisions before January 2007; and subject to an application for authorisation (either through Member State or else by applicant as appropriate) before January 2008 can continue to be used until six months after Commission non-authorisation decision (Article 28(6)) disease risk reduction claims (Article 14(1)(a)): cannot be used unless and until authorised so no phase out period new psychological, behavioural, slimming, weight control (Article 13(5)) and new children s development and health claims (Article 14(1)(b)) can continue to be used until six months after Commission non-authorisation decision (specified in Decision), despite contradiction of Article 28(6) 17

18 Transitional periods Concern and confusion over status of on hold claims transitional provisions post Regulation 432/2012: may continue to be used after 14 December 2012 pursuant to Articles 28(5) and 28(6) transitional periods (Recital 11) cut-off date does not apply to on holds six month phase out will apply from any non-authorisation 18

19 Conclusion Numerous issues in which practice and NHCR diverge with significant consequences for product positioning strategy increasingly under legal microscope Many interpretation issues remain exploit as alternative to individual authorisation as part of defensive product positioning strategy? Important milestone through adoption of a (not the final) permitted list of generally accepted (Article 13(1)) claims Options for post-december 2012 if not on permitted list? scope/business case for seeking, or relying on existing or pending, individual authorisation? alternative product positioning strategy? 19