Sellers of food supplements should ensure your notification
Although food supplements must be notified to the sanitary authorities by manufacturers, importers or distributors (since they are the ones who put the product on the market for the first time), sellers of food supplements to the final consumer (either in physical store or online ), must ensure that they are notified.
The sellers of final food supplements are responsible for the fact that a food supplement is sold in Spain under conditions not allowed by the applicable regulations as it is not previously notified by the responsible person.
The commercialization without notification of the product of the case constitutes an infraction in the matter of food security and is sanctioned with fines of up to 5,000.- € in accordance with the legislation that are detailed below:
“1. To facilitate the effective control of food supplements, the person in charge of marketing the product in Spain must notify the competent authorities of its placing on the national market, sending them a copy of the product label prior or simultaneous to the first time in the market. Said mandatory notification must be made by the manufacturer or the person responsible for the first placing on the market or the importer (in the case of third countries). For the purposes of the provisions of the preceding section: a) The notification of the placing on the national market of food supplements, of national manufacture or from other countries belonging to the European Union, shall be submitted to the competent autonomous community bodies by reason of the registered office of the manufacturer or the person responsible for the first placing on the market. The autonomous communities will communicate to the Spanish Agency of Food Safety and Nutrition for their knowledge the notifications they receive.”
- Article 11.2 of the aforementioned Royal Decree 1487/2009 states:
“In particular, failure to comply with the provisions of paragraphs b), e) and d) of article 4.1, as well as paragraph a) of the same article 4.1 is considered serious when it entails a risk to public health, of the Royal Decree 1334/1999, of July 31, which approves the General Standard for labeling, presentation and advertising of food products, pursuant to the provisions of article 35.B) .l. Of Law 14/1986 , of April 25, General of Health. Likewise, by virtue of the same legal provision, the breach of the provisions of sections 3, 4 and 5 of article 5, and the omission of the notification provided in article 9 of this royal decree is considered a serious offense ”.
“1. They are infractions in the matter of alimentary hygiene: (…) e) The breach of the requirements, conditions, obligations or prohibitions established in the specific norm in matter of hygiene or alimentary hygiene. “ Based on this article 50, the health authorities are sanctioning the sellers of final food supplements by considering that they do not comply with the requirements of the regulations for not ensuring or confirming that the food supplement that is being marketed is notified before the health authorities. Article 51 of this Law establishes as sanctions: “The infractions are classified as minor, serious and very serious, according to the criteria of health risk, position in the infringing market, amount of the possible benefit obtained, degree of intentionality, severity of the health alteration, generalization of the infraction and recidivism. They will be minor infractions: (…) -The elaboration, manufacture, transformation, packaging, storage, import, export, distribution, transport or commercialization of food and feed, under conditions not allowed by current regulations, or whose use has been expressly prohibited or restricted, provided that such breach is not classified as a serious or very serious infringement.”
The amount of the sanction to be imposed will be established by article 52 of the Law: “1. Violations in matters of food safety and nutrition provided for in this standard will be sanctioned by the competent public administrations with fines according to the following graduation: minor offenses: up to 5,000 euros” Therefore, it is important that sellers of food supplements to the consumer In the end, make sure that the accessories they sell are notified.
For this, at LegaleGo Food Safety Consulting we are specialized in notifications of food supplements having made more than 1,000 notifications by several countries in Europe in the last 6 years.