CBD Group

Procedure for determination of novel food status

  1. Food business operators shall verify whether the food which they intend to place on the market within the Union falls within the scope of this Regulation.
  2. Where they are unsure whether a food which they intend to place on the market within the Union falls within the scope of this Regulation, food business operators shall consult the Member State where they first intend to place the novel food. Food business operators shall provide the necessary information to the Member State to enable it to determine whether a food falls within the scope of this Regulation.
  3. In order to determine whether a food falls within the scope of this Regulation, Member States may consult the other Member States and the Commission.
  4. The Commission shall, by means of implementing acts, specify the procedural steps of the consultation process provided for in paragraphs 2 and 3 of this Article, including deadlines and the means to make the status publicly available. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3).

‘’Over the past twelve months we have seen a significant increase in CBD-infused products being sold throughout Europe. As a result of this rise, considerable thought should be taken in regulating this market and ensuring that consumers are being protected whilst also providing guidance, clarity and confidence to an ever-growing industry. This was the opportunity for The Novel Food Catalogue of the European Commission to provide complete clarification on the nature of CBD products that are being marketed and sold in European markets. Unfortunately, the re-classification of CBD and Cannabinoids as novel foods, has effectively rendered all CBD products used in food or as a food supplement across Europe as unlawful, denying consumers the right to access these products, from established retailers. This general prohibition comes at a time when CBD has come to the forefront of the media due to the significant research, which has shown it to have many therapeutic benefits.

In contrary to the overzealous re-classification, detailed research shows that cannabis and CBD was already used as a foodstuff in the territory of the present European Union long before 1997

It would have been desirable to clarify the legal situation and provide guidance to all parties involved in the CBD business, but this has not been achieved and instead, confusion prevails.’’ – Housam Nasr, London CBD Group

So, what can you do to ensure the products you sell comply with the legislation for novel foods?

There is a procedure for challenging such determinations. The next full committee meeting in Brussels on 12th March 2019 to address this issue and this presents an opportunity to make submissions to the committee and attend in person to make representations on behalf of the UK CBD industry.

Or you can apply for authorisation to sell products containing cannabinoids. Per Food Standards Agency’s website, there are two authorisation routes under the EU Novel Food Regulation no. 2015/2283 In both cases you must provide a dossier of information and submit it to the European Commission through an electronic portal. 

For all other novel foods, a full set of information is required to be submitted to the Commission which will ask the advice of EFSA where appropriate. EFSA has published guidance on the scientific requirements of an application.

 

It can take up to nine months for a risk assessment to be completed when further information is not required. If there is a positive EFSA opinion, the Commission has a further seven months to authorise the food and add it to the Union List of novel foods.

Enforcement

Local authorities, including Trading Standards and Environmental Health Officers, are responsible for the enforcement of novel foods legislation. If you have a concern about products being marketed which may be illegal or dangerous to health contact the relevant local authority.

Further reading:

Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 – https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2016.4594

Novel Foods https://www.food.gov.uk/business-guidance/novel-foods

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 (Text with EEA relevance) – https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2015_327_R_0001

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 (Text with EEA relevance.) – https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2017.351.01.0064.01.ENG&toc=OJ:L:2017:351:TOC