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EU Moves to Harmonise Authorisation Procedure For Novel Foods

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EU Moves to Harmonise Authorisation Procedure For Novel Foods

EU Moves to Harmonise Authorisation Procedure For Novel Foods
June 26
10:47 2015

Draft plans to encourage food innovation via a new, simplified authorisation procedure for novel foods, already informally agreed with the Council of Ministers, have been endorsed by the Environment Committee of the European Parliament. 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 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,” says lead MEP James Nicholson (ECR, UK).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.”

He continues: “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.”

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.

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