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Tuesday, April 30, 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:

 

The Regulation (EU) 2019/515 of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 has been published in the Official Journal of the EU on 29 March 2019.

Publication of a new regulation on mutual recognition

The European evaluation carried out between 2014 and 2016 indeed showed that the principle of mutual recognition does not function as it should. The aim of this new Regulation is to strengthen the functioning of the internal market by improving the application of the principle of mutual recognition and by removing unjustified barriers to trade.

 

The evidence required to demonstrate that goods are lawfully marketed in another Member State varies significantly from Member State to Member State.

That’s why a major new provision is that the producer of goods may draw up a voluntary declaration of lawful marketing of goods for the purposes of mutual recognition (‘mutual recognition declaration’) in order to demonstrate to the competent authorities of the Member State of destination that the goods, or the goods of that type, are lawfully marketed in another Member State.

 

This new regulation shall apply from 19 April 2020. In the meantime, changes in national notification procedures may be possible to take into account this new text.

 

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

Thursday, April 25, 2019
Category : NEWS, INGREDIENTS, CLINICAL EVIDENCE | 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:

 

This pilot clinical study, aimed to determine the effects of daily supplementation during 6 months with 1×108 CFU of Lactobacillus salivarius PS7, selected for its antagonism of otophathogens, in the prevention of otitis in 61 children suffering of recurrent acute otitis media.

 

Supplementation with Lactobacillus salivarius prevents recurrent acute otitis in children.

Comparison between the number of AOM episodes reported during the 6 months of the probiotic treatment and those reported during the previous 6 months. **, statistically significant change (p < 0.05; ¬χ2 test).

Thirty six percent (36%) of the recruited children suffered at least one episode of acute otitis media, with a median duration of 4 days. In contrast, 70% of the children with recurrent acute otitis media who were attended by the same pediatrician in the same period but did not receive the probiotic strain suffered at least one acute otitis media episode with a median duration of 6 days. The number of acute otitis media episodes during the 6-month intervention period decreased by 84% when compared to the number registered in the 6 months that preceded the intervention (Figure 1). Moreover, the microbial density in the external auditory canal decreased notably along the intervention period, from >3.5 log10 CFU at the baseline (all the cultures were positive at this sampling time) to <2 log10 CFU at the end of the intervention (with 22% of the cultures being negative).

In conclusion, Lactobacillus salivarius PS7 is a promising strain for the prevention of recurrent acute otitis media in infants and children.

 

Cárdenas N, Martín V, Arroyo R, López M, Carrera M, Badiola C, Jiménez E, Rodríguez JM. Prevention of Recurrent Acute Otitis Media in Children Through the Use of Lactobacillus salivarius PS7, a Target-Specific Probiotic Strain. Nutrients. 2019 Feb 12;11(2).

 

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, April 23, 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 10years by more than 500 industry leaders informs you:

 

On 17 April 2019, the French authorities decided, as a precaution, to ban the placing on the market of foodstuffs (including food supplements) containing titanium dioxide (E171) from 1 January 2020.

ban of titanium dioxide (E 171) from the 1rst January 2020

This decision follows the new opinion of ANSES (French scientific evaluation agency) published on 15 April 2019 highlighting the lack of scientific data to remove the uncertainties on the safety of the additive E171 (consisting of particles of titanium dioxide (TiO2) especially in nanoparticulate form). ANSES reiterates its recommendations for data to characterize the physicochemical forms of E171 and additional toxicological data on the potential effects related to their ingestion.

Under these conditions, in accordance with the provisions of Article 53 of the French law “Agriculture and Food” published on 1 November 2018 and the announcement made by Bruno Le Maire on 11 January 2019, an order suspending the placing on the market of foodstuffs containing additive E171 from 1 January 2020 has been signed and will be published shortly.

As the additive E171 is authorized at European Union level, this order will have to be notified to the European Commission and the other Member States, which will meet within 10 days to examine this measure.

We will keep you informed of the answer of the European Authorities, however we recommend to study as soon as possible reformulation solutions to change this additive for the French market.

 

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

Thursday, April 18, 2019
Category : NEWS, INGREDIENTS, CLINICAL EVIDENCE | 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:

 

The aim of this randomized, double-blind and placebo-controlled trial was to investigate the efficacy and safety of Nigella sativa seed oil in the treatment of patients with non-alcoholic fatty liver disease (NAFLD).

To do so, 120 patients with non-alcoholic fatty liver disease were randomized to receive either 2.5mL of a fully standardized N. sativa seed oil every 12h or a placebo for 3 months.

Beneficial effect of Nigella sativa supplementation on non-alcoholic fatty liver disease.

 

Results showed that grade of hepatic steatosis was significantly reduces in the oil group compared to the placebo (p = 0.004). Moreover, triglycerides, LDL-C and HDL-C were significantly decreased compared to placebo (p = 0.001, p = 0.01, p = 0.001 respectively). However, the oil did not significantly affect the other outcome variables compared to the placebo (all p > 0.05).

Authors concluded that Nigella sativa seed oil seems to be safe and improve liver disorders in the NAFLD patients.

 

Khonche A, Huseini HF, Gholamian M, Mohtashami R, Nabati F, Kianbakht S. Standardized Nigella sativa seed oil ameliorates hepatic steatosis, aminotransferase and lipid levels in non-alcoholic fatty liver disease: A randomized, double-blind and placebo-controlled clinical trial. J Ethnopharmacol. 2019 Apr 24;234:106-111.

 

 

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

Wednesday, April 17, 2019
Category : NEWS | Author : experts | Comment : No Comments
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Are you ready to discover the future way to develop

new products thanks to Artificial Intelligence?

 

Let’s book a meeting at Vitafoods with our experts

to discover our latest innovations:

 

NOL Datasolution , to CREATE your new products

thanks to regulatory, scientific data & products benchmarking.

 

NOL Compliance to LAUNCH your products into the different EU member states,

thanks to compliance, labeling generation and monitoring & update at anytime

 

See here how NOL Solutions will help you:

Click here to see the video

 

Depending on your availability during these 3 days of show, you can schedule an appointment with our team,

booth F60, using the form below:

to book an appointment, it’s here

 

 

Come and meet our team at Vitafoods, Geneva, May 7th-9th, Nutraveris’ experts will be pleased to welcome you booth F60

See you soon, booth F60 !

 

Nutraveris’ team

 

 

More information on www.nutraveris.com

Contact our Scientific & Regulatory experts at NUTRAVERIS

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