Today, the new EU Novel Foods Regulation was published in the EU’s Official Journal. The new Regulation, which will apply as of January 1, 2018, simplifies the process of authorizing a novel food for placement on the EU market. As a result, companies selling foods considered novel in the EU, including certain traditional foods from third countries, are expected to obtain faster and easier access to the EU market.
The new Regulation establishes a centralized procedure with an authorization assessment at EU level, replacing the current system of national evaluations. The new procedure introduces generic authorization of novel foods to be placed on a so-called “Union list,” replacing the previous applicant-based system in which authorization was granted to the applicant only. Moreover, the new Regulation simplifies the authorization of traditional foods with a safe history in third countries, updates data protection rules to protect innovation, and introduces new safety controls.
To ensure continuity with currently applicable rules, the new Regulation continues to generally define “novel food” as a type of food which was not consumed in the EU to a significant degree before May 1997. It also updates and clarifies the definition of novel food to include food consisting of engineered nanomaterials and food from animal clones (until specific legislation on such food enters into force). The new Regulation excludes from its scope GMOs and food intended to be used for technological purposes.
One of the key changes introduced by the new Regulation is a centralized authorization procedure, which allows food business operators to submit applications directly to the European Commission. Once authorized at EU level, the novel food will be placed on a Union list containing generic authorizations, which are available to all business operators. This replaces the current procedure whereby companies must apply to a Member State competent authority for authorization to market a novel food and where authorization is applicant-specific. The generic authorization also replaces the current “simplified procedure” whereby an applicant must prove that a novel food intended to be placed on the EU market is “substantially equivalent” to existing foods.
To ensure specific protection of the investments made by innovative companies, the new Regulation allows applicants to request that newly developed scientific evidence or scientific data related to the novel food application may not be used by another applicant for five years from the date of authorization.
New safety controls will apply to authorized novel foods after they are placed on the EU market. The Commission is now entitled to impose specific post-market monitoring requirements, which could include the identification of the relevant food business operators. In addition, companies are required to inform the Commission of any new scientific or technical information affecting the safety of an authorized novel food, or of any prohibition or restriction of the novel food in a third-country market.
The new Regulation provides welcome efficiencies and opportunities for companies in the novel foods industry. In particular, companies should reap financial benefits from the new EU-level authorization procedure and the protection of investments made to bring novel foods to the EU market. Companies should keep in mind that applications currently being assessed by Member States will be governed by the new Regulation if they are not finalized before the new rules apply.
If you have any questions regarding this Sidley Update, please contact the Sidley lawyer with whom you usually work, or
| Maurits Lugard Partner mlugard@sidley.com +32 2 504 6417 |
Maarten Meulenbelt Partner mmeulenbelt@sidley.com +32 2 504 6467 |
Josefine Sommer Associate josefine.sommer@sidley.com +32 2 504 6427 |
Sidley EU Life Sciences Practice
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