ANVISA publishes Technical Regulation lactose labeling
On February 9th 2017, ANVISA, the Brazilian Health Regulatory Agency, concluded the technical regulation process of lactose labeling on food products. This resulted in two resolutions: RDC 135/2017 and RDC 136/2017. The complete text of these ordinances (in Portuguese) can be downloaded below.
RDC 135/2017 modifies Ordinance SVS/MS 29/1998 that regulates foodstuff products for special needs and diets, while RDC 136/2017 establishes the requirements for the mandatory declaration of the presence of lactose in food labels for products containing over 100 milligrams of lactose per 100 grams/milliliters of product.
RDC 135/2017 creates the following two categories:
- Lactose-free products. Foodstuff products (including drinks, ingredients, food additives and technology adjutants) containing less than 100 milligrams per 100 grams/milliliters of product. These products must insert one of the following text options: "isento de lactose", "zero lactose", "0% lactose", "sem lactose" or "não contém lactose". This text must be placed close to the commercial name of the product.
- Products with reduced lactose content. Foodstuff products (including drinks, ingredients, food additives and technology coadjutors) containing more than 100 milligrams per 100 grams/milliliters of product and less than 1 gram per 100 grams/milliliters of product. These products must insert one of the following text options: "baixo teor de lactose" or "baixo em lactose" close to the commercial name of the product.
RDC 136/2017 establishes the requirements for the mandatory declaration of the presence of lactose in food labels for products containing over 100 milligrams of lactose per 100 grams/milliliters of product. For products reaching those levels producers must insert the words "Contém lactose" right after or under the list of ingredients with the format requirements established in its art. 4.
Regulation RDC 135/2017 will be enforced as of 9 February 2019, whereas RDC 136/2017 will be mandatory for industrial products or food service/catering industry (not directly intended for final consumers) as of 9 February 2018 and for consumer products as of 9 February 2019. Products manufactured before the date of enforcement of these provisions will be allowed on the market until the end of their expiration dates.
Stickers can be used to comply with the requirements of these provisions as long as they obey the format and pattern requirements set by the related regulation. However, as several languages can be used to display the required information, multi-language packaging, including the reference to lactose content in several languages, might be a solution for producers to avoid the use of stickers or dedicated packaging (see picture).
Anvisa is expected to publish a guide of Q&A with additional information on the subject in the coming days.
Should you have specific questions regarding the interpretation, implementation or any other aspect of these texts please contact the agriculture team LAN in Brasilia (BRA-LNV@minbuza.nl).