Nutraveris

Category 'REGULATORY'

Tuesday, February 12, 2019
Category : NEWS, INGREDIENTS, REGULATORY | Author : experts | Comment : No Comments
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NOL, Nutraveris Online, the most efficient data solution to create, keep up-to-date and launch your products in the 28 EU member states, used for 10 years by more than 500 industry leaders informs you:

The Novel food Catalogue entries for Cannabis sativa L. and Cannabidiol / Cannabinoids have been updated in January 2019 and now indicate that :

  • “Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore, are not novel. Other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States.” Only ingredients derived from hemp seed are now cited as having a history of consumption in the EU.
  • “Extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.”

This modification clarifies that the European Authorities consider that it is forbidden to market food or food supplements containing cannabidiol in all the European Union (considered as novel according to Regulation (EU) 2015/2283). For information a novel food application for trans-cannabidiol (for a use in food supplements) is under assessment by EFSA and the opinion is expected to be published in March 2019.

 

Cannabis sativa

 

For example in UK where some cannabidiol products were already marketed because of an unclear legal context, it is now indicated on the website of the FSA: There has been a recent change to the EU Novel Food Catalogue which affects some cannabidiol (CBD) products. Food businesses have not been able to show there was a significant history of consumption of these products in food and food supplements prior to May 1997 in the EU. The FSA are considering the way forward in light of this clarification at EU level (meeting with relevant industry representative bodies, local authorities and other stakeholders to clarify how to achieve compliance in the marketplace in a proportionate manner).

 

This information has been sourced by NOL, a collaborative and complete tool which contains all Regulatory, Scientific and Marketing data

  • It solves all regulatory issues since it contains the required information on all ingredients authorized in the 28 European member states…on regulatory status, health claims, authority opinions
  • It protects your investments since it is updated in real time with reliable quality information analyzed and reviewed by our experts, available hotline.
  • It enables you to be the most responsive with monthly reports and live alerts and a personal use of the information with a report editing tool and customizable bookmarks.

With NOL let’s : 

  • Formulate new innovative products
  • Check if your already existing formulas are still compliant with the in force regulations
  • Adapt your existing formulas to the requirements of other European countries where you are willing to export them
  • Do scientific & regulatory & marketing monitoring which enable to anticipate the withdrawal of products, the safety issues, new interesting scientific studies, the arrival of new players on the market…

 

More information on www.nutraveris.com

Contact our Scientific & Regulatory experts at NUTRAVERIS

contact@nutraveris.com, +33 2 96 76 54 87

Tuesday, February 5, 2019
Category : NEWS, REGULATORY | Author : experts | Comment : No Comments
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NOL, Nutraveris Online, the most efficient data solution to create, keep up-to-date and launch your products in the 28 EU member states, used for 10years by more than 500 industry leaders informs you:

 

In 2019, the European elections will take place between 23 and 26 May 2019 to elect the MEPs representing the Member States of the European Union, and the European Commission will change at the end of 2019.

European changes in 2019

Concerning the Brexit (departure of the United Kingdom from the European Union) the discussions at European level on a draft Withdrawal Agreement are still ongoing. Two main scenarios are still possible:

  • the Withdrawal Agreement is ratified before 30 March 2019: in this case, European Union law would continue to apply in the United Kingdom until 31 December 2020 (transition period).
  • or the Withdrawal Agreement is not ratified by 30 March 2019: this is the “no deal” scenario, implying that EU law will no longer apply in the UK from 30 March 2019.
    We invite you to follow further discussions on this topic by 30 March 2019.

According to information from the UK authorities, the main safety principles of European food law will be converted into UK law. However adaptations will be needed, particularly:

  • The UK would no longer fall within the scope of the mutual recognition principle.
  • Concerning the mandatory labelling of food, changes will be necessary for the address:

For pre-packed products sold in the UK, the label would need to include the name and a UK address of the responsible food business operator. The food business operator is the business under whose name the food is marketed in the UK or, if that operator is not established in the UK, the importer of the product into the UK. An EU address alone would no longer be valid for the UK market.

Similarly, a UK address alone would no longer be valid for the EU market and an address within the remaining EU member states will be required following EU exit.

A UK address together with an EU address on the label would mean that the label is valid for both the UK and EU markets.

 

This information has been sourced by NOL, a collaborative and complete tool which contains all Regulatory, Scientific and Marketing data

  • It solves all regulatory issues since it contains the required information on all ingredients authorized in the 28 European member states…on regulatory status, health claims, authority opinions
  • It protects your investments since it is updated in real time with reliable quality information analyzed and reviewed by our experts, available hotline.
  • It enables you to be the most responsive with monthly reports and live alerts and a personal use of the information with a report editing tool and customizable bookmarks.

With NOL let’s : 

  • Formulate new innovative products
  • Check if your already existing formulas are still compliant with the in force regulations
  • Adapt your existing formulas to the requirements of other European countries where you are willing to export them
  • Do scientific & regulatory & marketing monitoring which enable to anticipate the withdrawal of products, the safety issues, new interesting scientific studies, the arrival of new players on the market…

 

More information on www.nutraveris.com

Contact our Scientific & Regulatory experts at NUTRAVERIS

contact@nutraveris.com, +33 2 96 76 54 87