Recent Developments in EU Food Regulation

As part of a new series in EAS-E-News on services provided through EAS partnerships, Italy-based food technology and consulting firm Almater shares the following insights on regulatory developments in the EU in the area of foods, including so-called novel foods.

The European Union has significantly revised its legal and regulatory framework for novel foods in recent years, as well as its requirements for labeling, presentation and advertising of food.

The EU updated its 1997 regulation on novel foods with the adoption of a new novel food regulation (No 2283/2015) on November 25, 2015. The regulation, a centralized authorization procedure for novel foods at EU level, offered new provisions on nano-ingredients and on “insect-food,” and a simplified authorization procedure for “traditional products” from third countries. It also clarified requirements for food produced from cloned animals.

Under EU law, a “novel food” means any food that was not used for human consumption to a significant degree within the Union before May 15, 1997. Genetically modified foods fall within a different regulatory framework, as do food additives, enzymes, flavorings and extraction solvents. Some food categories may fall within the scope of the novel food regulation, requiring a prior-authorization to access the EU market. These include: food with a new or intentionally modified molecular structure (for instances a patented synthetic polymer); food from microorganisms, fungi or algae (such as extracts obtained from a mycelium cultivated in a submerged fermentation), food from plants or their parts, or from animals or their parts (for instances lipid extract from a specie of krill), food from cell culture or tissue culture (upcoming cultured meat, for example).

The novel food regulation also includes food consisting of engineered nanomaterials, food consisting of, isolated from or produced from material of mineral origin and food resulting from a new production process.

From January 1, 2018, the EU marketing authorization procedure will be centralized at the European Commission, which will evaluate novel food applications taking into account the European Food Safety Authority’s risk assessment and “other legitimate factors.” The current individual licensing authorizations will be replaced by generic permissions.

The novel food regulation allows applicants protection – for a limited time – for new scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the EU list. The regulation also includes a simplified authorization procedure for traditional foods from third countries that have historically proved safe for food use.

The novel food regulation includes a better definition and ad hoc provisions on nano-ingredients. As the term “engineered nanomaterials” is currently defined in Regulation (EU) No 1169/2011, nano-ingredients are considered novel foods under EU law. The Commission is called upon to reformulate this definition to reflect scientific and technological change and internationally agreed definitions. EFSA and EU Member State risk assessors are working to enforce scientific and regulatory framework on nanoscience and nanotechnologies in the food and feed chain. The novel foods regulation provides a clear opening for the use of whole insects and their parts in foods, if they pass an EFSA risk assessment.

Regulation (EU) No 2283/2015 entered into effect on January 11, 2016 and will become fully applicable from January 1, 2018, except for certain provisions.

EU regulatory framework on food information

The EU’s regulation on the provision of food information to consumers (No 1169/2011), which went into effect in December 2014, will be fully applicable from December 2016 for nutrition declarations on prepacked food.

A cornerstone of food labeling in the EU market, this regulation requires new mandatory information on allergens and nutrition. In addition, it includes new requirements for specific products such as nano-ingredients, refined oils/fats of vegetable or animal, de-frozen foods or formed fish/meat etc.

The regulation also broadens the role of the European Commission.

Third-Party Certification Will be Critical for Import Safety

The Food and Drug Administration released an amended final rule last month establishing user fees so the agency can administer the FSMA program for accreditation of third-party certification bodies to conduct food safety audits.

The fees apply to accreditation bodies seeking FDA recognition as well as to third-party certification bodies that seek direct accreditation from FDA. In addition to application fees, the agency will also seek annual user fees and renewal fees.

Third-party certification is an important component of FSMA’s preventive approach. The landmark food safety legislation gave FDA the authority to require risk-based import certification of food. And importers can use facility certifications to qualify for other programs such as the Voluntary Qualified Importer Program (VQIP), which offers expedited review of import entries of food.

In a separate December 14 notice, FDA issued a fee schedule for fiscal year 2017, effective from January 13 through September 30, 2017. The hourly fee for review work by FDA staff will be $204 excluding travel costs — or $285 per hour if travel is involved, the agency says.

The estimated application fee, including travel, for an accreditation body seeking direct accreditation from FDA in FY 2017 will be $35,100. The agency estimates it will take 60 “person-hours” to review an accreditation body’s application, 48 person-hours for an onsite performance evaluation of the applicant, and 45 person-hours to prepare a written report documenting the onsite assessment.

In its justification of the fees, the agency offered some insights into its typical costs for overseas travel. In fiscal year 2015, for example, FDA’s Office of Regulatory Affairs spent more than $2.5 million on 269 foreign inspection trips for programs related to the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The average cost was $9,373 per foreign inspection trip and the trips averaged 3 weeks or 120 paid hours.

Because this user fee program is just getting under way, renewals and annual fees will not be collected in 2017, but the agency has set the following estimated fees for planning purposes:

  • Annual fee for a recognized accreditation body — $1,579.
  • Annual fee for an accredited certification body — $1,974.
  • Annual fee for a certification body directly-accredited by FDA — $20,208.
  • Renewal application fee for a recognized accreditation body — $18,855.
  • Renewal application fee for a certification body directly-accredited by FDA — $26,460.

FDA says there will be no exemptions or reduced fees for participation in the program by small businesses or entities or for public-sector entities. It notes that the cost to the agency for performing the application review and monitoring “will not vary greatly regardless of the entity’s size or public versus private status.”

I believe the third-party certification program provides FDA a way to extend its reach and leverage its resources to improve the safety of food imported into the United States. And although fee-based programs are unpopular among the regulated community, they do allow the agency to reliably fund programs that are scalable and sustainable.