Date: 2015-07-02Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2015/1052 of 1 July 2015 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk (Text with EEA relevance)
Executive Summary:
Commission Regulation (EU) 2015/1052 of 1 July 2015, concerns the refusal to authorise certain health claims made on foods. The regulation follows evaluations by the European Food Safety Authority (EFSA) on applications for health claim authorisations and considers comments received. This regulation specifies which health claims will not be included in the Union list of permitted claims and took effect on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
Health Claim Authorisation:
* Health claims made on foods require Commission authorisation to be included in a list of permitted claims, according to Regulation (EC) No 1924/2006.
* Applications for health claim authorisations are submitted by food business operators to national competent authorities, which then forward valid applications to EFSA.
* The Commission decides on the authorisation of health claims, considering EFSA's opinion.
Refused Health Claims:
* An application from SANOFIAVENTIS FRANCE to extend the conditions of use for plant sterol esters in powder form to lower blood LDL-cholesterol was refused due to insufficient data to establish the effective dose.
* A health claim from Jemopharm AS regarding CranMax and the reduction of urinary tract infection risk by inhibiting bacteria adhesion was also refused because a cause-and-effect relationship was not established.
* The health claims listed in the Annex shall not be included in the Union list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.
Implementation:
* This Regulation is binding in its entirety and directly applicable in all Member States.
Impact Analysis:
Food Business Operators:
* Impact: Food business operators, such as SANOFIAVENTIS FRANCE and Jemopharm AS, are directly affected as their specific health claims were not authorised.
* Action Required: These operators must not use the rejected health claims on their products and need to ensure compliance with the regulation regarding health claims on food products.
European Commission:
* Impact: The Commission is responsible for making decisions on health claim authorisations, considering EFSA's opinions, and ensuring compliance with Regulation (EC) No 1924/2006.
* Action Required: The Commission must update and maintain the Union list of permitted health claims, excluding those refused by this regulation.
European Food Safety Authority (EFSA):
* Impact: EFSA is tasked with evaluating the scientific evidence supporting health claims and providing opinions to the Commission.
* Action Required: EFSA must continue to assess applications for health claims and provide scientific opinions to the Commission.
Member States:
* Impact: National competent authorities within Member States are responsible for receiving and forwarding health claim applications to EFSA.
* Action Required: Member States must enforce the regulation and ensure that food business operators within their jurisdiction comply with the permitted health claims list.
Consumers:
* Impact: Consumers are indirectly impacted as the regulation affects the information available on food products regarding health claims.
* Action Required: No direct action is required, but consumers should be aware that only authorised health claims are permitted on food products.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the day-to-day business of the EU.
Regulation EC No 1924/2006: A European Parliament and Council regulation on nutrition and health claims made on foods.
European Food Safety Authority (EFSA): An agency of the European Union that provides independent scientific advice on food-related risks.
SANOFIAVENTIS FRANCE: An applicant company that submitted an application pursuant to Article 19(1) of Regulation EC No 1924/2006 for modification of a health claim.
Commission Regulation EC No 983/2009: A Commission Regulation on the authorisation and refusal of authorisation of certain health claims made on food.
Commission Regulation EU No 384/2010: A Commission Regulation on the authorisation and refusal of authorisation of certain health claims made on foods and referring to the reduction of disease risk and to children's development and health.
Jemopharm AS: An applicant company that submitted an application pursuant to Article 14(1)(a) of Regulation EC No 1924/2006 for a health claim related to CranMax.
2.7.2015 EN Official Journal of the European Union L 171/5
COMMISSION REGULATION (EU) 2015/1052
of 1 July 2015
refusing to authorise certain health claims made on foods and referring to the reduction of disease
risk
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006
on nutrition and health claims made on foods (1), and in particular Article 17(3) thereof,
Whereas:
(1) Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are
authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.
(2) Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be
submitted by food business operators to the national competent authority of a Member State. The national
competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter
referred to as ‘the Authority’.
(3) Following receipt of an application the Authority is to inform without delay the other Member States and the
Commission thereof, and to deliver an opinion on the health claim concerned.
(4) The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by
the Authority.
(5) Following an application from SANOFI-AVENTIS FRANCE submitted pursuant to Article 19(1) of Regulation (EC)
No 1924/2006 and including a request for protection of proprietary data, the Authority was required to deliver
an opinion on the modification of the authorisation of a health claim related to plant sterol esters and lowering
blood LDL-cholesterol. That health claim has been authorised, pursuant to Article 14(1)(a) of Regulation (EC)
No 1924/2006, by Commission Regulations (EC) No 983/2009 (2) and (EU) No 384/2010 (3). The applicant
requested an extension of the conditions of use, as provided for in Regulation (EC) No 983/2009 as amended by
Regulation (EU) No 376/2010 (4) and in Regulation (EU) No 384/2010 in its original version, to powder
supplements to be diluted in water at a dose of 2 g per day, which would lower blood LDL-cholesterol concen
trations by ‘5,4-8,1 %’ after six weeks of daily consumption.
(6) On 21 February 2014, the Commission and the Member States received a scientific opinion from the Authority
(Question No EFSA-Q-2013-00595) (5) which concluded that while plant sterols added to foods such as
margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts, including low-fat
yoghurts, and cheese have been shown consistently to lower blood LDL-cholesterol concentrations in a large
number of studies, the effective dose of plant sterols (as powder diluted in water) needed to achieve a given
magnitude of effect in a given timeframe, as requested by the applicant, cannot be established with the data
provided.
(7) In accordance with the second paragraph of Article 16(6) of Regulation (EC) No 1924/2006, the applicant or
members of the public may make comments to the Commission on opinions published by the Authority
pursuant to the first paragraph of Article 16(6) of that Regulation. On 14 April 2014, the Commission requested
the Authority to respond to the scientific comments received from the applicant according to Article 16(6) of
(1) OJ L 404, 30.12.2006, p. 9.
(2) Commission Regulation (EC) No 983/2009 of 21 October 2009 on the authorisation and refusal of authorisation of certain health
claims made on food and referring to the reduction of disease risk and to children's development and health (OJ L 277, 22.10.2009,
p. 3).
(3) Commission Regulation (EU) No 384/2010 of 5 May 2010 on the authorisation and refusal of authorisation of certain health claims
made on foods and referring to the reduction of disease risk and to children's development and health (OJ L 113, 6.5.2010, p. 6).
(4) Commission Regulation (EU) No 376/2010 of 3 May 2010 amending Regulation (EC) No 983/2009 on the authorisation and refusal of
authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and
health (OJ L 111, 4.5.2010, p. 3).
(5) EFSA Journal 2014;12(2):3577.L 171/6 EN Official Journal of the European Union 2.7.2015
Regulation (EC) No 1924/2006. The comments were related to the scientific evaluation of the Authority on the
extension of the conditions of use to plant sterol esters in powder, in particular to the intervention study on
which the conclusion of the adopted scientific opinion was based and to a new published meta-analysis which
was submitted with the comments.
(8) On 21 May 2014, the Commission received the Authority's response to the comments on the scientific opinion
(Question No EFSA-Q-2014-00310) (1) in which the Authority reiterated the conclusion of its scientific opinion
(Question No EFSA-Q-2013-00595) with respect to the intervention study. The Authority added that the new
published meta-analysis does not provide additional information for the scientific substantiation of the extension
of the conditions of use to plant sterol esters in powder. Accordingly, as under the requested conditions of use
the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
(9) Following an application from Jemo-pharm A/S submitted pursuant to Article 14(1)(a) of Regulation (EC)
No 1924/2006 and including a request for protection of proprietary data, the Authority was required to deliver
an opinion on a health claim related to the effect of CranMax® and reduction of the risk of urinary tract infection
by inhibiting the adhesion of certain bacteria in the urinary tract (Question No EFSA-Q-2013-00649) (2). The
claim proposed by the applicant was worded as follows: ‘Prevent adhesion of E. coli to the uroepithelial cells in
women which is a risk factor for developing urinary tract infections’.
(10) On 5 May 2014, the Commission and the Member States received the scientific opinion from the Authority,
which concluded that on the basis of the data presented, a cause and effect relationship has not been established
between the consumption of CranMax® and reduction of the risk of urinary tract infection by inhibiting the
adhesion of certain bacteria in the urinary tract. Accordingly, as the claim does not comply with the requirements
of Regulation (EC) No 1924/2006, it should not be authorised.
(11) The comments received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have
been considered when setting the measures provided for in this Regulation.
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as
provided for in Article 14(1) of Regulation (EC) No 1924/2006.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 July 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) EFSA supporting publication 2014:EN-596.
(2) EFSA Journal 2014;12(5):3657.ANNEX
Rejected health claims
Application — Relevant provisions of Regulation (EC) Nutrient, substance, food or
Claim EFSA opinion reference
No 1924/2006 food category
Modification, pursuant to Article 19, of an Article 14(1)(a) Plant sterol esters Plant sterol esters presented as food supplement in powder Q-2013-00595
health claim referring to a reduction of a disease risk. sachet have been shown to lower/reduce blood cholesterol.
High cholesterol is a risk factor in the development of coron
ary heart disease.
Article 14(1)(a) health claim referring to a reduction of a dis CranMax® Prevent adhesion of E. coli to the uroepithelial cells in Q-2013-00649
ease risk. women which is a risk factor for developing urinary tract
infections.
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