Draft plans to encourage food innovation via a new, simplified authorisation procedure for novel foods, already informally agreed with the Council of Ministers, were endorsed by the Environment Committee on Thursday. In talks, MEPs insisted that foods from cloned animals must be clearly included in the scope of the regulation, as must the precautionary principle, measures to keep nanomaterials under scrutiny and animal testing restrictions.
“The outcome of today's vote on novel foods is great news for our agri-food industry” said lead MEP James Nicholson (ECR, UK) after the outcome of negotiations with the Latvian Presidency of the Council was approved by 36 votes to 29, with 3 abstentions. The draft rules, which still need to be approved by Parliament as a whole and the Council of Ministers, would subject novel foods to safety evaluation and authorization via a fully harmonized EU-wide procedure.
"To reject this proposal would have risked extending the shelf life of an old regulation that is no longer fit for purpose. Our agri-food sector is constantly changing, constantly adapting and constantly improving. We need a legislative framework in place to keep up with technological developments of the past twenty years, for instance with regard to nanotechnology and cell and tissue cultures”, Mr Nicholson continued.
"A new, single and centralised procedure for the authorisation of novel foods and more robust data protection will provide greater legal certainty for applicants, reduce the administrative burden for SMEs, and therefore encourage further innovation in the agri-food sector across Europe. The novel foods regulation has had a long, and arduous, history in the European Parliament. Today's vote marks an important breakthrough for those who have made, and continue to make, the European food sector a world leader in high-quality and innovative food products", he added.
Cloning, precautionary principle
As requested by MEPs in negotiations, the agreed text explicitly covers foods from cloned animals. The scope also includes food consisting of, isolated from or produced from cell or tissue cultures derived from animals, plants, micro-organisms, fungi or algae.
When deciding whether to authorise a novel food, the European Commission will have to apply the precautionary principle if its safety cannot be assessed or in the event of scientific uncertainty. The text stipulates that the European Food Safety Authority (EFSA), should carry out an assessment in every case where a food is liable to have an effect on human health.
The regulation would also reduce the time limit for the Commission to decide on whether a novel food could be placed on the market from 9 to 7 months, and allow it one month to refer the application to the EFSA. It would also make it easier to place traditional foods from third countries on the market.
The text includes a definition of nanomaterials, which may be updated, via a delegated act, to keep pace with scientific progress. Using a delegated act would ensure that the European Parliament has a say in how the definition is updated. The text also calls for a better assessment of nanotoxicokinetics and the toxicology of these materials. Micelles and liposomes are now also explicitly mentioned in the text.
Tests on animals should be replaced, reduced or refined, says the text, and duplication of animal testing should be avoided where possible. The Commission would be required to publish a summary of every application, and the list of rejected applications.
The text will be put to a vote by Parliament as a whole at a Strasbourg plenary session in September or October.
Note to editors
A draft law to ban the cloning of all farm animals, their descendants and products derived from them, including imports, in the EU was voted by the Environment and Agriculture committees on 17 June (see press release).
A “novel” food is one that was not used for human consumption within the EU to a significant degree before 15 May 1997. MEPs tightened up this definition to include, inter alia, food with a modified molecular structure, microorganisms, fungi, algae, food obtained from cellular or tissue cultures, or insects.
"Traditional" foods from third countries would be allowed on the EU market provided they have a history of safe consumption that has been demonstrated for at least 25 years.