Notice of Release of Food Supplements on the Market

A highly competitive and innovative market where mistakes can be costly

Before releasing supplements such as sports supplements, probiotics, multivitamins, iron or calcium supplements, etc. on the market, manufacturers must ensure that they meet the requirements for approval by the competent authorities. Some marketers of food supplements see this as a mere communication procedure. However, simply notifying your intent to market a product does not imply approval by the administration: although the operator can start marketing these products, they can be liable for any irregularity inherent in the product or for deficiencies in its labeling, which can even imply provisional withdrawal from the market for rectification, something that will give an advantage to competitors and may have economic and image consequences.

Puesta mercado complementos alimenticios

We are your most solvent partner when releasing food supplements on the market

At Aconsa we start from the premise that a laboratory that carries out composition analysis of products has extensive knowledge of the regulations in the matter and has extensive experience in accompanying companies in placing their food products on the market, including food supplements, is the one who can provide the best advice in a procedure that depends largely on correct information about a product.

What does the process consist of?

1

We analyze the product:

Spanish legislation places stricter limits on the components with nutritional and physiological effects that can be included in a dietary supplement than other countries, making it necessary to check if the composition complies with the requirements, both in the presence or absence of components and their amounts. For this, analysis such as high-resolution liquid chromatography (HPLC), mass spectroscopy (MS) and infrared spectroscopy (IR) may be necessary, among others.
2

We review the label:

The regulations stipulate that the food supplement labels must have very specific characteristics regarding content, such as the specification of the category of nutrients or substances that characterize the product and their quantities with specific values, indicators and expressions, the recommended dose, the expiration date, specific legal claims about the consumption of food supplements, etc., and regarding the format, such as the location of the information within the label, font size, etc.
3

We file the notice of release on the market:

We file the notice of release of the product on the market in Spain following the fastest and most economical route for the client, including the lowest amount possible in terms of fees. Sometimes it may be necessary to look for alternatives to filing the notice in Spain, due to the limitations on the composition that the supplement can incorporate, such as releasing the product in another EU country in order to apply the Principle of Mutual Recognition.
4

Correction of errors

In cases where customers have started the notice filing process for market entry through other means and are faced with requirements from the administration in matters they had not anticipated, we help them rectify the mistakes, issuing replies in time and form, etc.

Advisory services associated with filing a notice of release of food supplements on the market

General orientation on necessary procedures and competent administration in each case
Regulatory assessment of the formula for compliance with regulations
Evaluation and translation of legal texts for labeling
Notifications of market launches in different EU countries
Request for Spanish National Code for Pharmacy specializing in the sale of over-the-counter medications and health and beauty products.

What is the purpose of this service?

A notice of the release of food supplements and other related procedures must be filed by laboratories, manufacturers, importers, and distributors of food supplements, as well as any other applicable pharmacy items like cosmetics and personal care products, baby food and nursery items, special medical use foods, etc.

European companies without a registered address in Spain that wish to sell their products in Spain who are accountable to the Spanish Agency for Food Safety and Nutrition (AESAN).

Companies based in Spain that want to sell imported products in Spain who are accountable to AESAN.

Spanish companies wanting to export products manufactured in Spain within the EU, who are accountable to the autonomous community where they have their registered office.

A highly competitive and innovative market where mistakes can be costly

We are your most solvent partner when releasing food supplements on the market

What does the process consist of?

We analyze the product:

We review the label:

We file the notice of release on the market:

Correction of errors

Advisory services associated with filing a notice of release of food supplements on the market

What is the purpose of this service?

Do you need support with marketing food supplements?