Excessive requirements and novelty foods

Subject: Excessive requirements and novelty foods

A high level of protection of human health, consumers’ interests and the effective functioning of the internal market needs to be ensured in the pursuit of EU food policies.

The procedure for authorising the placing on the market within the Union of a novel food, based on Regulation (EU) 2015/2283 and Commission Implementing Regulation (EU) 2017/2469, requires applicants to submit various data necessary for the assessment. However, in many instances there are excessive requirements that are not technically possible to be fulfilled by small and medium-sized companies seeking to gain authorisation for their products. Such technical and scientific data requirements are often costly to fulfil, since the prices for analyses can amount to tens of thousands of euros. This constitutes a significant barrier for such companies in placing their products on the market. In this regard:

1. To what extent is the Commission aware of issuing excessive requirements and how does it address this issue?

2. What measures can small and medium-sized companies use to mitigate the costs incurred by the Commission’s excessive requirements?

3. Why does the Commission issue excessive requirements when assessing CBD-related products vis-à-vis other applications?

Answer given by Ms Kyriakides on behalf of the European Commission

(28 February 2022)

In order to meet the EU citizens’ expectations for a high level of health protection, the co-legislators have put in place a legislation on novel foods (1) that requires, for all of them, a comprehensive range of safety data, to be assessed by the European Food Safety Authority (EFSA), which acts in full independence and up to the highest scientific standards.

Recognising the need to enable and support European small economic operators and facilitate the placing on the market of safe and innovative products, the Commission has adopted a number of measures aimed at creating a business friendly environment (2), facilitating access to finance (3), improving access to markets (4), fostering competitiveness (5), and innovation (6) for small and medium enterprises.

In addition, Horizon Europe (7), the EU programme for research and innovation, will continue to provide funding opportunities.

The basic requirements for authorising the placing on the market within the Union of a novel food are laid down in the novel food regulation and the relevant implementing regulation (8).

There is no distinction made in that legislation between cannabidiol (CBD)-derived products and other novel foods in terms of requirements.

However, EFSA may require additional information during the assessment of any novel food, if deemed necessary to establish its safety, before it may be authorised.

⋅1∙ Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the

European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001. OJ L 327, 11.12.2015, p. 1.

⋅2∙ Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions

entrepreneurship 2020 action plan reigniting the entrepreneurial spirit in Europe, COM/2012/0795 final. ⋅3∙ https://europa.eu/youreurope/business/finance-funding/getting-funding/access-finance/index_en.htm ⋅4∙ https://ec.europa.eu/growth/access-finance-smes/cosme-financial-instruments_en ⋅5∙ https://ec.europa.eu/growth/industry_en#competitiveness

⋅6∙ https://ec.europa.eu/growth/industry/policy/innovation_en

⋅7∙ https://ec.europa.eu/info/research-and-innovation/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe_en

⋅8∙ Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in

Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. OJ L 351 30.12.2017, p. 64.