Document ID: 02010R0384-20140711
Language: ENG

02010R0384 — EN — 11.07.2014 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION REGULATION (EU) No 384/2010</p><p>of 5 May 2010</p><p>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&#8217;s development and health</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 113 6.5.2010, p. 6)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION REGULATION (EU) No 686/2014&#160;of 20 June 2014</a></p></td><td><p>&#160;&#160;L&#160;182</p></td><td><p>27</p></td><td><p>21.6.2014</p></td></tr></table>
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
(Text with EEA relevance)
Article 1
The health claim set out in Annex I to this Regulation may be made on foods on the European Union market in compliance with the conditions set out in that Annex.
That health claim shall be included in the Community list of permitted claims referred to in Article 14(1) of Regulation (EC) No 1924/2006.
Article 2
The health claims set out in the Annex II to this Regulation shall not be included in the Community list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.
Article 3
This Regulation shall enter into force on the 20th day following 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.
ANNEX I
Permitted health claim
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Application &#8212; Relevant provisions of Regulation (EC) No 1924/2006</p></td><td><p>Applicant &#8212; Address</p></td><td><p>Nutrient, substance, food or food category</p></td><td><p>Claim</p></td><td><p>Conditions of use of the claim</p></td><td><p>Conditions and/or restrictions of use of the food and/or additional statement or warning</p></td><td><p>EFSA opinion reference</p></td></tr><tr><td><p>Article 14(1)(a) health claim referring to a reduction of a disease risk</p></td><td><p>Danone France, 150 Bd Victor Hugo, 93589 Saint-Ouen Cedex, France</p></td><td><p>Plant sterols/Plant stanol esters</p></td><td><p>Plant sterols and plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.</p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-3 g plant sterols/stanols. Reference to the magnitude of the effect may only be made for foods within the following categories: yellow fat spreads, dairy products, mayonnaise and salad dressings. When referring to the magnitude of the effect, the range &#8216;7 % to 10 %&#8217; for foods that provide a daily intake of 1,5-2,4 g plant sterols/stanols or the range &#8216;10 % to 12,5 %&#8217; for foods that provide a daily intake of 2,5-3 g plant sterols/stanols and the duration to obtain the effect &#8216;in 2 to 3 weeks&#8217; must be communicated to the consumer.<span>&#160;&#9668;</span></p></td><td><p>&#160;</p><div/></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;<br/> Q-2008-779<br/> Q-2009-00530 and Q-2009-00718<br/> Q-2011-01241<span>&#160;&#9668;</span></p></td></tr></tbody></table>
ANNEX II
Rejected health claims
<table><col/><col/><col/><col/><tbody><tr><td><p>Application &#8212; Relevant provisions of Regulation (EC) No 1924/2006</p></td><td><p>Nutrient, substance, food or food category</p></td><td><p>Claim</p></td><td><p>EFSA opinion reference</p></td></tr><tr><td><p>Article 14(1)(a) health claim referring to a reduction of a disease risk</p></td><td><p>Lycopene-whey complex</p></td><td><p>Lycopene-whey complex prevents oxidative damage of plasma lipoproteins, which reduces the build up of arterial plaques and reduces the risk of heart disease, stroke and other clinical complications of atherosclerosis</p></td><td><p>Q-2008-703</p></td></tr><tr><td><p>Article 14(1)(a) health claim referring to a reduction of a disease risk</p></td><td><p>Bimuno<span>TM</span> (BGOS) Prebiotic</p></td><td><p>Regular consumption of Bimuno<span>TM</span> (BGOS) Prebiotic helps to protect against the bad bacteria than can cause the travellers&#8217; diarrhoea</p></td><td><p>Q-2009-00232</p></td></tr></tbody></table>
<note>
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 2 ) The EFSA Journal (2009) 1177, 1-12.
( 3 ) The EFSA Journal (2009) 1175, 1-9.
( 4 ) The EFSA Journal (2009) 1179, 1-10.
( 5 ) The EFSA Journal (2009) 1105, 1-9.
</note>