Originating Department: Service public fédéral Santé publique, Sécurité de la Chaîne alimentaire et Environnement
Responsible Department: SPF Economie, PME, Classes moyennes et Energie
Received: 2017-05-10 00:00:00
Country: Belgium
Category: AGRICULTURE, FISHING AND FOODSTUFFS
Ministerial decree amending the Ministerial Decree of 19 February 2009 regarding the manufacture and marketing of food supplements that contain substances other than nutrients and plants or plant preparations
Notification No.: 2017-0182-B
1. ------IND- 2017 0182 B-- EN- ------ 20170517 --- --- PROJET
1. ------IND- 2017 0182 B-- EN- ------ 20190508 --- --- FINAL
The Kingdom of Belgium _________ FEDERAL PUBLIC SERVICE FOR HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT ________________________ Ministerial decree amending the Ministerial Decree of 19 February 2009 regarding the manufacture and marketing of food supplements that contain substances other than nutrients and plants or plant preparations The Public Health Minister, Having regard to Article 2 of the Law of 24 January 1977 on the protection of consumer health in regard to foodstuffs and other products; Having regard to Article 3 of the Royal Decree of 12 February 2009 on the manufacture and commerce of food supplements that contain substances other than nutrients and plants or plant preparations; Having regard to the opinions of the Superior Health Council, given on 2 December 2009, 11 January 2012 and 3 February 2016; Having regard to the opinion of the Advisory council on food policy and the utilisation of other consumer goods, given on 18 April 2017; Having regard to the opinion of the Finance Inspector, given on 22 March 2017; Having regard to opinion XXXXX of the Council of State, given on XXXXX pursuant to Article 84, § 1(2), of the consolidated laws on the Council of State of 12 January 1973; Having regard to the communication to the European Commission, of XXXXX, pursuant to Article 5(1) of Directive 2015/1535/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services; Considering the Minister’s guideline based on the opinion of the Joint Commission concerning products containing red yeast rice, issued on 7 December 2016; HEREBY DECREES: Article 1. Article 2 of the Ministerial Decree of 19 February 2009 regarding the manufacture and marketing of food supplements that contain substances other than nutrients and plants or plant preparations shall be supplemented by a paragraph worded as follows: ‘Products, other than those containing red yeast rice, placed on the market or labelled before [publication date + 10 days] and which do not meet the provisions of the latter may continue to be marketed until stocks have been exhausted or, at the very latest, by [date of signature + 1 year].’. Article 2. In the annex to the same decree, the following entries shall be added to the list of other substances whose use in food supplements is subject to conditions, as follows:
The Kingdom of Belgium _________ FEDERAL PUBLIC SERVICE FOR HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT ______________________ Ministerial decree amending the Ministerial Decree of 19 February 2009 regarding the manufacture and marketing of food supplements that contain substances other than nutrients and plants or plant preparations The Minister for Public Health, Having regard to Article 2 of the Law of 24 January 1977 on the protection of consumer health in regard to foodstuffs and other products; Having regard to Article 3 of the Royal Decree of 12 February 2009 on the manufacture and marketing of food supplements that contain substances other than nutrients and plants or plant preparations; Having regard to Ministerial Decree of 19 February 2009 regarding the manufacture and marketing of food supplements that contain substances other than nutrients and plants or plant preparations; Having regard to the opinions of the Superior Health Council, given on 2 December 2009, 11 January 2012 and 3 February 2016; Having regard to the opinion of the Advisory council on food policy and the utilisation of other consumer goods, given on 18 April 2017; Having regard to the opinion of the Finance Inspector, given on 22 March 2017; Having regard to the communication to the European Commission on 10 May 2017 pursuant to Article 5(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services; Having regard to the request for an opinion No 63.826/3 within 30 days and lawfully extended by 15 days, pursuant to Article 84(1)(1)(2) of the laws on the Council of State, consolidated on 12 January 1973, sent to the Council of State on 27 June 2018 and listed on 2 July 2018; Considering the lack of communication of the opinion within this period; Having regard to Article 84(4)(2) of the laws on the Council of State, consolidated on 12 January 1973; Considering the Minister’s guideline based on the opinion of the Joint Commission concerning products containing red yeast rice, issued on 7 December 2016; HEREBY DECREES: Article 1. Article 2 of the Ministerial Decree of 19 February 2009 regarding the manufacture and marketing of food supplements that contain substances other than nutrients and plants or plant preparations shall be supplemented by a paragraph worded as follows: ‘Products, other than those containing Monascus purpureus (red yeast rice) or any other source of monacolin K, placed on the market or labelled before [publication date + 10 days] and which do not meet the provisions of the latter may continue to be marketed until stocks have been exhausted or, at the very latest, by 26 October 2019.’. ’. Article 2. In the annex to the same decree, the following entries shall be added to the list of other substances whose use in food supplements is subject to conditions, as follows:
Other substance: Food supplements containing other substances may not be placed on the market unless the following conditions have been met: the quantity of the other substance ingested during absorption of the daily portion recommended in the labelling, presentation or advertising, must comply with the following maximum or minimum levels: without prejudice to the general and specific provisions concerning the labelling, presentation and advertising of foodstuffs, food supplement labelling must include a warning, the content of which is as follows: other conditions: Caffeine Maximum: 80 mg/day (total) To be mentioned on the external packaging: ‘Unsuitable for children or pregnant or lactating women.’ The warning must appear in the same visual field as the name of the foodstuff, followed, in brackets, by a reference to the caffeine level expressed in mg per recommended daily portion The caffeine level refers to the total amount of caffeine, including from plants and other sources. Lutein Minimum: 2 mg/day Maximum: 10 mg/day Lycopene Minimum: 2.5 mg/day Maximum: 15 mg/day Only products complying with Regulation (EC) No 258/97 and (EU) 2015/2283 on novel food ingredients shall be permitted. Monascus purpureus (red yeast rice) or any other source of monacolin K Maximum: 10 mg/day monacolin K To be mentioned on the external packaging: ‘This product is unsuitable for pregnant or lactating women, children and adolescents, those over 70 years of age, those with liver, kidney or muscular problems, or taking medicinal products liable to interact (e.g. cholesterol-lowering drugs) or those intolerant to statins. If in doubt, please seek advice from your doctor or pharmacist.’ Only products complying with Regulations (EC) No 258/97 and (EU) 2015/2283 on novel food ingredients shall be permitted. The maximum level of citrinin must meet the requirements of Regulation (EU) No 212/2014. The monacolin K dosage must be standardised (maximum divergence 10 %) The level of monacolin K must be mentioned in the notification file.
Other substance: Food supplements containing other substances may not be placed on the market unless the following conditions have been met: the quantity of the other substance ingested during absorption of the daily portion recommended in the labelling, presentation or advertising, must comply with the following maximum or minimum levels: without prejudice to the general and specific provisions concerning the labelling, presentation and advertising of foodstuffs, food supplement labelling must include a warning, the content of which is as follows: other conditions: Caffeine Maximum: 80 mg/day (total) Labelling shall comply with Annex III(4.2) of Regulation (EU) No 1169/2011 on the provision of food information to consumers. In accordance with these provisions, the caffeine level refers to the total amount of caffeine, including from plants and other sources. Lutein Minimum: 2 mg/day Maximum: 20 mg/day Lycopene Minimum: 2.5 mg/day Maximum: 15 mg/day Only products complying with Regulation (EU) 2015/2283 on novel foods shall be permitted. Monascus purpureus (red yeast rice) or any other source of monacolin K Maximum: 10 mg/day monacolin K To be mentioned on the external packaging: ‘This product is unsuitable for pregnant or lactating women, children and adolescents, those over 70 years of age, those with liver, kidney or muscular problems, or taking medicinal products liable to interact (e.g. cholesterol-lowering drugs) or those intolerant to statins. If in doubt, please seek advice from your doctor or pharmacist.’ Only products complying with Regulation (EU) 2015/2283 on novel foods shall be permitted. The maximum level of citrinin must meet the requirements of Regulation (EU) No 212/2014. The monacolin K dosage must be standardised (maximum divergence 10 %). The level of monacolin K must be mentioned in the notification file.
Brussels, (date) Maggie DE BLOCK
Brussels, 26 October 2018 Maggie DE BLOCK
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