Models of Control projects on Nutrition and health claims What makes a control project successful? How to enforce the outcomes in regular controls? Petra Bergkvist, Government Inspector, National Food Agency, Sweden Sari Sippola, Senior Officer Finnish Food Safety Authority Evira, Finland Nordic Supervisory Conference, 25-27 of January, 2016
Headlines Introduction to Reg (EC) No 1924/2006 on Nutrition and Health Claims
Comparing the Swedish and the Finnish control projects on claims • Aims and structures • Education and communication • Scope of the inspections • Inspection methods • Outcome of the controls • Compliance of the rules and coercive measures of non-conformity • Experiences of the inspections, sucsees factors • Enforcement on the outcomes of the projects
Introduction to Reg (EC) No 1924/2006 on Nutrition and Health Claims
Nutrition claim A claim, made by text, brand name, graphs, symbols or pictures implying that a specific food has beneficial nutritional properties due to its
• content or increased content of for example a specific vitamin, protein, a specific mineral, non- saturated fatty acids or
• reduced content or lack of of energy, fat, sugars, fatty acids
Health claim A commercial claim, made by text, brand name, graphs, symbols or pictures implying a relationship on foods or constituents of a food and health
”Tasty and healthy”
Conditions of use of the nutrition and health claims • A minimum or maximum level of the nutrient in the food or information on a minimum intake each day • Compulsory nutrition information declaration and amount of substance of which the claim is made of (art. 7) • Statement on the importance of varied and balanced diet and a healthy lifestyle (art. 10(2)a)
• Information on the quantity of food to be consumed to obtain the health effect (art. 10(2)b)
• When appropriate; statements on persons who should avoid the product and a warning to consume excessive amounts of products likely to present a health risk, if they are consumed in excess (art. 10(2)c and d). • In a disease risk reductation claim, a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect. (art. 14(2)).
Project period The Swedish project: August 2013 - June 2015 Inspection period: Jan- June 2014
The Finnish project: August 2013 - May 2014 Inspection period: Oct 2013 - April 2014
Aims of the projects Sweden •
Skilling the control authorities in the regulation on nutrition and health claims
•
Yield an overview of the compliance with the rules of the operators
•
demonstrate how offenses are handled by the enforcement authorities
•
increased knowledge of the rules on nutrition and health claims among the operators
Finland •
Educate the Municipal Food Control Authorities (MCFA) to control the health claims – Facilitate the control – Harmonize the control of health claims in Finland
•
Bring the demands of the Claims Regulation for the use of health claims to the knowledge of FBO’s – Educate the FBO’s to carry out in-house control
Structure of the projects Sweden • Targeting oFBOs responsible for labelling • Control of labelling • Voluntary participation of CA, voluntary number of products controlled. • Ordinary foods (no food supplements) • Education prior to the control • Local control authorities in ordinary control • Electronic reports • Electronic questionary on estimation of competence of the authority prior and post inspection period
Finland •
•
MCFA’s together with RSAA’s (Regional State Administrative Agency) chose the FBO’s for health claim inspections Recommended criterias for the selection of FBOs: – Significant manufactures or importers – Both normal foodstuffs and food supplements – FBO’s that have had problems with marketing – MCFA’s own choices – Inspections should be diveded in balanced way to different coltrol units so that as many inspectors as possible could get education on the control of health claims
Education and communication Sweden • Guidance to the Regulation published i spring 2014. • PP education on legislation and examples of interpretation of labelling available on our digital community Livstecknet before and during the inspection period • Discussions and questions between NFA and CA by the digital community
Finland •
Before inspection day – All the inspection materials were send by email to MCFAs (inspection form, inspection guide, guidebook on claims) – Evira had earlier years arranged several seminars on claims
•
Inspection day – Meeting in the office of the MCFA – Discussion of the FBO and their products and marketing – Short education on basis of Claims regulation and how to use the inspection form – Education at inspection side for both FBO and MCFA inspectors
Scope of the inspections Sweden •
Nutrition claims, general (article 13.1) health claims and non specific claims (article 10.3)
•
Labelling, except pictures, brand names. Shelf edges included
•
Ordinary pre-packed foods, as bread, fish and dairy products, energy drinks and non-prepacked bread
•
Conformity of claims, content of the adressed nutrient
•
Presence of medical claims
•
Presence of a nutrition declaration in the labelling
•
Mandatory information on diet, lifestyle, quantity to consume and, where appropriate, a warning
•
Reporting how non conformity was judged
Finland •
Assesment of the status of used claims in the labelling and/or marketing material (including internet) – Accepted (Commissions register, Efsa’s question register, transition period) – Denied (medicinal, article 3 or article 12) – General non-spesific claims – Pictures, symbols, product names, brand names, graphics etc.
•
Assessment of conditions of use – Adequate amount of substance
•
Labelling reguirements – Nutrition declaration/Characteristic substances – Additional statements required by article 10(2)a-d or art. 14(2)
Inspection methods Sweden • Inspections in the ordinary control of FBO´s by the CA (not assisted)
• Tools – Digital inspection form – Education Guide – Nutrition and Health Claim Guide for food supervisors and food business operators – Commission´s and Efsa´s register
Finland •
Guided and assisted inspections – The inspections were carried out by Evira’s project person who also wrote the healht claim inspection form – Both municipalities supervisor and the FBO were educated at the same time
•
Tools – Inspection Form for Health claims – Inspection Guide on Nutrition and Health Claims – Nutrition and Health Claim Guide for food supervisors and food business operators – Commission’s and EFSAs registers
Outcome of the controls Some statistics… Sweden •
•
35 control authorities participating, 31 reporting full information 82 FBOs controlled
• 124 products included in the evaluation • Ordinary food; bread, brakfast cereals juice, •
•
seeds, nuts, dairy , fishery products, Energy drinks, margarines
76 products bearing nutrition claim
• 72 products bearing health claim • High share non prepacked bread
Finland • • •
33/66 MFCA attended to the project from all of the 6 RSAA inspection was conducted in 45 FBO The use of health claims was checked in 152 products: – – – – – – – –
99 food supplements 10 milk and milk products 9 berry products 9 sport products 8 soft drinks 5 herbal tea products 4 bee products 2 cereal products, 2 honey, 1 vegetable oil, 1 birch sap, 1 bean product, 1 linseed product
Compliance of the rules on health claims, Sweden Violations in the use of health claims
•
Vast majority of health claims are non specific
•
A very minor part of the non specific claims were accomplished of permitted health claims
•
Wording of the ”authorised” claim crucial to control
•
Mandatory information according to art 10.2 ( healthy life-style, quantity of food to be consumed in order to get the health effect etc not in the label
•
In the majority of the pre-packed products a nutrition declaration was available
N= 72 92 % of products with some non conformity
3% 5%
3 % of the products labelleld with medical claims 92%
5 % labelled in conformity to the controlled rules
Compliance of the rules on nutrition claims, Sweden Violations in use of nutrition claims
50%
50%
50 % of the products labelled in conformity to the controlled rules 50% of the products with some non conformity
•
A larger share of products fullfilled the controlled part of the rules on nutrition claims
•
A high share of claims concerned ”vitamins” and ”minerals” and LCHF
•
Claims on content of fatty acids and omega-3 fatty acids is complex and needs careful scrutinizing
•
Nutrition declaration available in the majority of products
Compliance of the rules, Finland D 26%
57 % of inspected products contained Nonaccepted health claims (C)
A 11% B 6%
26 % of inspected products contained medicinal claims (D) 6 % of inspected products contained accepted claims, but had minor mistakes (B)
C 57%
11 % of inspected products contained health claims that were all accepted and the product fulfilled requirements for conditions of use (A)
Compliance of the rules, Finland Amount of FBOs having guidelines for the use of claims in owncheck plan No 16 %
Yes 53 % Partly 31 %
Coercive measures of non-conformity Sweden •
No significant result on the coercive measures, high level of ”other measures” reported, shadowing over the other alternatives • Medical claims on two products, - one product follow up next planned control - one product Removal in a short period of time
•
Finland Medicinal claim – Internet Immediate removal (few days) – Labelling Stopping the delivery of stocks, if it can be covered with stickers, than release – Other marketing material Immediate stopping of delivery, withdrawal from the shops
•
Non-accepted health claim • •
•
Internet Removal in a short period of time (1-2 weeks) Labelling Correction to the next packages, if the storage rotation time is less than half year, if longer the hole storage cannot be sold, covering with sticker if possible Other marketing material Stopping of delivery
Experiences of the inspections Sweden •
This regulation is very complicated to control!
Finland •
Feedback from the MFCA of ”Guided control projects” has always been very positive and they are found to be a good way to educate complicated control areas
•
The self-estimated control competence by CA of the claims regulation increased from 2.6 to 3.5 (scale 1-5) n = 33
•
The support to the CA from the project leader was valued to 4.0 (by 5) n = 33
•
•
Disappointment by many CA of the lack of operators meeting the criteria for the control project, and thus the CA were excluded from participating
The health claim control project got a grade 4,6 (scale 1-5) from inspectors (n=24)
•
BUT…We don’t see that the amount of claims inspections has increased after the project…
•
In some cases the CA have made assessments other than NFA in controlled products.
•
High falling off of CA due to staff shortage
Success factors on the control projects Sweden •
Finland
Project group with local CA + NFA elaborating the extent of the questionary
•
Education
•
Clear instructions
•
Education and guidance
•
Involve the participants in very early state
•
Project had high priority at the NFA •
On-line help/back up (health claims reguire a lot of interpretation)
•
Almost immediate backup and support to the CA during their inspections
Enforcement of the outcomes of the projects Sweden
Finland
•
Inspection checklist for claims
•
Start to do the job, otherwise the edge of controling will be more difficult
- Minor violations, probably less misleading
•
• Including health claims control in control of traceability
Specialization of control personel in the control area
•
Continue to do the control in project manner? (check all the FBOs using health claims at the same period)
• Check list based upon severity of violation: - most misleading/medical claims:
• Build up of a competence group of local CA+ Central Control authority lining out interpretation of the rules and coercive measures facilitates equivalent valuation of violations
Workshop Your experiences and ideas: 1) What makes a control project successful? 2) How to enforce the outcomes of the project in to regular controls?
3) Make a short summary in each group
Thank you for your attention! Questions?
