Nutraveris

Category 'REGULATORY'

Tuesday, July 16, 2019
Category : NEWS, INGREDIENTS, REGULATORY | Author : experts | Comment : No Comments
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Our Artificial Intelligence solutions, developed by our experts, NOL Datasolution to Create & NOL Compliance to Launch your products, inform you :  

 

In Italy, the Istituto Superiore di Sanità reported 21 cases of acute, non-infectious and non-contagious cholestatic hepatitis following the consumption of products containing turmeric. The Italian Authorities are carrying out checks to identify the cause of these cases of hepatitis. Pending the analysis, consumers are requested, as a precaution, to suspend the consumption of numerous products.

 

Alerts on food supplements containing turmeric

The Belgian Authorities have also issued a warning about a company which decided to withdraw a product containing turmeric and black pepper from sale.

The French Authorities are awaiting the return of the investigations of the Italian Authorities.

To date the exact cause of the adverse effects is not yet clearly established.

 

NUTRAVERIS is the Leading European consultancy on Regulatory & Scientific affairs in Nutrition and Health, founded 13 years ago, to help you formulate, ensure the compliance and substantiation of your products in the 28 EU Member States. 

Thanks to our strong know-how and experience of regulatory compliance, notifications, novel foods, health claims, medical writing,…We, as experts, created Artificial Intelligence solutions, that we use in our everyday missions:
-NOL Datasolution to CREATE new products thanks to Regulatory, Scientific & Marketing data.
-NOL Compliance to LAUNCH products into the different EU member states thanks to automated Compliance analysis, Labeling generation and Monitoring & updating at anytime.

More information on www.nutraveris.com

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Tuesday, July 9, 2019
Category : NEWS, REGULATORY | Author : experts | Comment : No Comments
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Our Artificial Intelligence solutions, developed by our experts, NOL Datasolution to Create & NOL Compliance to Launch your products, inform you :  

 

Following the approval by the European Parliament on 17 April 2019, the Council has formally adopted on 13 June 2019 a new Regulation on the transparency and sustainability of the EU risk assessment in the food chain. This new Regulation mainly amends the General Food Law Regulation (178/2002). It aims at increasing the transparency of the EU risk assessment in the food chain, on strengthening the reliability, objectivity and independence of the studies used by European Food Safety Authority (EFSA), and revisiting the governance of EFSA.

 

The Regulation stipulates that all studies and information supporting a request for a scientific output by EFSA are to be made public. This will be done at the very early stage of the risk assessment process, in an easily accessible electronic format with the possibility to search, download and print the studies. Confidential information will be protected in duly justified circumstances. Confidentiality claims will be assessed by EFSA.

Other measures which will also ensure a more robust, independent and transparent risk assessment process are particularly:

  • A notification obligation for applicants and laboratories when studies are commissioned and creation of a database of commissioned studies: This will provide a mechanism by which EFSA will be able to double-check whether all studies commissioned by an applicant in the context of its application for an authorisation, have been submitted;
  • Consultation of stakeholders and of the general public on submitted studies to ensure EFSA’s comprehensive access to existing evidence underpinning its risk assessment;
  • Pre-submission advice on the applicable rules and the required content of an application dossier, to be provided by EFSA upon request to potential applicants;
  • Fact-finding missions by the Commission to ensure the compliance of laboratories/studies with standards;
  • Possibility for the Commission to ask EFSA to commission studies in exceptional circumstances to verify evidence used in its risk assessment process.

 

The new Regulation is expected to be published in the Official Journal in September 2019 and will become applicable 18 months later.

 

NUTRAVERIS is the Leading European consultancy on Regulatory & Scientific affairs in Nutrition and Health, founded 13 years ago, to help you formulate, ensure the compliance and substantiation of your products in the 28 EU Member States. 

Thanks to our strong know-how and experience of regulatory compliance, notifications, novel foods, health claims, medical writing,…We, as experts, created Artificial Intelligence solutions, that we use in our everyday missions:
-NOL Datasolution to CREATE new products thanks to Regulatory, Scientific & Marketing data.
-NOL Compliance to LAUNCH products into the different EU member states thanks to automated Compliance analysis, Labeling generation and Monitoring & updating at anytime.

More information on www.nutraveris.com

Contact our Scientific & Regulatory experts at NUTRAVERIS

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

 

Tuesday, July 2, 2019
Category : NEWS, REGULATORY | Author : experts | Comment : No Comments
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Our Artificial Intelligence solutions, developed by our experts, NOL Datasolution to Create & NOL Compliance to Launch your products, inform you :  

 

EFSA published on 15 May 2019 a technical report on Risk evaluation of chemical contaminants in food in the context of RASFF notifications.

EFSA technical report on Risk evaluation of chemical contaminants in food in the context of RASFF notifications

 

An evaluation on the level of risk is necessary to decide if a RASFF notification should be issued. EFSA was requested to propose a risk evaluation methodology that would allow a rapid and consistent risk‐based classification of RASFF notifications.

The methodology aims to provide a transparent set of criteria that can support the decision whether to notify in RASFF and increase transparency and harmonization. The methodology was developed for evaluation of contaminants (arising from food contact materials, pharmacologically active substances and other food contaminants) in food.

The risk evaluation is based on the assessment of toxicological properties and dietary exposure. The result, expressed as the comparison of exposure to a relevant toxicological reference point, can be classified as no risk; low probability of adverse health effects or low concern for public health; potential risk; or risk.

 

NUTRAVERIS is the Leading European consultancy on Regulatory & Scientific affairs in Nutrition and Health, founded 13 years ago, to help you formulate, ensure the compliance and substantiation of your products in the 28 EU Member States. 

Thanks to our strong know-how and experience of regulatory compliance, notifications, novel foods, health claims, medical writing,…We, as experts, created Artificial Intelligence solutions, that we use in our everyday missions:
-NOL Datasolution to CREATE new products thanks to Regulatory, Scientific & Marketing data.
-NOL Compliance to LAUNCH products into the different EU member states thanks to automated Compliance analysis, Labeling generation and Monitoring & updating at anytime.

More information on www.nutraveris.com

Contact our Scientific & Regulatory experts at NUTRAVERIS

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

Tuesday, June 4, 2019
Category : NEWS, REGULATORY | Author : experts | Comment : No Comments
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Our Artificial Intelligence solutions, developed by our experts, NOL Datasolution to Create & NOL Compliance to Launch your products, inform you :  

 

 vitamin D and erucic acid

The Delegated Regulation (EU) 2019/828 published on 23 May 2019 amends the Delegated Regulation (EU) 2016/127 with regard to vitamin D requirements for infant formula and erucic acid requirements for infant formula and follow-on formula:

The maximum content for vitamin D in infant formula is lowered to 2,5 μg/100 kcal (instead of 3 μg/100 kcal).

the maximum content for erucic acid in infant formula and follow-on formula is lowered to 0,4 % of the total fat content (instead of 1%).

 

NUTRAVERIS is the Leading European consultancy on Regulatory & Scientific affairs in Nutrition and Health, founded 13 years ago, to help you formulate, ensure the compliance and substantiation of your products in the 28 EU Member States. 

Thanks to our strong know-how and experience of regulatory compliance, notifications, novel foods, health claims, medical writing,…We, as experts, created Artificial Intelligence solutions, that we use in our everyday missions:
-NOL Datasolution to CREATE new products thanks to Regulatory, Scientific & Marketing data.
-NOL Compliance to LAUNCH products into the different EU member states thanks to automated Compliance analysis, Labeling generation and Monitoring & updating at anytime.

More information on www.nutraveris.com

Contact our Scientific & Regulatory experts at NUTRAVERIS

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

Tuesday, May 21, 2019
Category : NEWS, REGULATORY | Author : experts | Comment : No Comments
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Our Artificial Intelligence solutions, developed by our experts, NOL Datasolution to Create & NOL Compliance to Launch your products, inform you :  

Maximum level of citrinin in food supplements based on rice fermented with red yeast Monascus purpureus is currently 2000 µg/kg according to Regulation (EC) 1881/2006.

 

rice fermented with red yeast

A draft regulation that will lower this maximum level for citrinin from 2000 µg/kg to 100 µg/kg has been voted by European Commission and Member States during the Standing Committee on Plants, Animals, Food and Feed – Section Novel Food and Toxicological Safety of the Food Chain on 29 March 2019.

The final text is expected to be published in the coming months.

 

NUTRAVERIS is the Leading European consultancy on Regulatory & Scientific affairs in Nutrition and Health, founded 13 years ago, to help you formulate, ensure the compliance and substantiation of your products in the 28 EU Member States. 

Thanks to our strong know-how and experience of regulatory compliance, notifications, novel foods, health claims, medical writing,…We, as experts, created Artificial Intelligence solutions, that we use in our everyday missions:

-NOL Datasolution to CREATE new products thanks to Regulatory, Scientific & Marketing data.

-NOL Compliance to LAUNCH products into the different EU member states thanks to automated Compliance analysis, Labeling generation and Monitoring & updating at anytime.

More information on www.nutraveris.com

Contact our Scientific & Regulatory experts at NUTRAVERIS

 +33 2 96 76 54 87