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March 20, 2019 | ANSM

ANSM: a mandatory warning on leave-on cosmetics containing phenoxyethanol

By a Health Police Decision of 13 March 2019, published on the ANSM website on 20 March, the French National Agency for the Safety of Medicines and Health Products requires manufacturers of leave-on cosmetic products containing the preservative Phenoxyethanol to indicate on the label that they may not be used on the buttocks of children aged 3 years or under. The Responsible Persons for making these products available on the market have a 9-month period to apply this measure.

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Labelling of Phenoxyethanol on baby products
20 March 2019 ANSM

ANSM: a mandatory warning on leave-on cosmetics containing phenoxyethanol

By a Health Police Decision of 13 March 2019, published on the ANSM website on 20 March, the French National Agency for the Safety of Medicines and Health Products requires manufacturers of leave-on cosmetic products containing the preservative Phenoxyethanol to indicate on the label that they may not be used on the buttocks of children ...

An email address for whistleblowers
06 Feb. 2019 ANSM

ANSM: an email address dedicated to whistleblowers

In order to facilitate the declaration of alerts made by whistleblowers and to strengthen their follow-up, the National Agency for the Safety of Medicines and Health Products has set up a procedure via a specific e-mail address. This procedure is in line with the French law on transparency, fight against ...

Injunction of the ANSM to the company Bio Perche Cosmétiques & Senteurs
16 Dec. 2018 ANSM

Injunction of the ANSM to the company Bio Perche Cosmétiques & Senteurs pro

It is because of “non-compliances and significant deficiencies” that the ANSM has just sent to Bio Perche Cosmétiques & Senteurs company a compliance injunction concerning its Lamblore facility. The cause: several deviations relating to compliance with the requirements of Cosmetics Regulation 1223/2009 and ISO 22716 on Good Manufacturing Practices.

Injunction of ANSM
18 Nov. 2018 ANSM

Injunction of the ANSM to the company Prodene Klint pro

It is because of “non-compliances and significant deficiencies” that the ANSM has just sent to Prodene Klint company a compliance injunction concerning its Alby-sur-Chéran facility. The cause: several deviations relating to compliance with the requirements of ISO 22716 on Good Manufacturing Practices.

ANSM injunction
22 Sept. 2018 ANSM

Injunction of the ANSM to the company Probionat Provence pro

It is in the name of"nonconformities and significant breaches" that the ANSM has just sent Probionat Provence a compliance injunction concerning its establishment in La Fare les Oliviers. In question: several discrepancies relating to compliance with the requirements of ISO standard 22716 on Good Manufacturing Practices.

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24 Aug. 2018 ANSM

Injunction of the ANSM to the company Laboratoires Cinq Mondes

It is in the name of"major non-conformities and shortcomings" that the ANSM has just sent Laboratoires Cinq Mondes an injunction to bring its Paris establishment into conformity. In question: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009 and ISO standard 22716 on Good Manufacturing Practices.

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25 July 2018 ANSM

Lessonia, Alès Groupe, Laboratoires Gilbert : 3 injunctions from the ANSM pro

It is in the name of"non-compliances and significant breaches" that the ANSM has just sent the companies Lessonia, Alès Groupe and Laboratoires Gilbert compliance injunctions relating respectively to their establishments in Croas Ar Neizic, Bezons, and Hérouville-Saint-Clair. In question: several discrepancies relating to compliance with the requirements of ISO ...

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06 July 2018 ANSM

Injunction of the ANSM to the Lorcos company pro

It is in the name of"nonconformities and important failures" that the ANSM has just sent to the Lorcos company an injunction to bring its Lunéville establishment into conformity. In question: several discrepancies relating to compliance with the requirements of ISO standard 22716 on Good Manufacturing Practices.

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03 July 2018 ANSM

ANSM : Ask for the program ! pro

The year has already started well, but the ANSM has only just published, on 26 June, its work programme for 2010. In this 24-page document, three mention cosmetic products. Selected excerpts.

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10 June 2018 ANSM

Injunction of the ANSM to the company Universkin pro

It is in the name of"nonconformities and important failures" that the ANSM has just sent to the company Universkin an injunction to bring its Nice establishment into conformity. In question: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009.

ANSM Logo, Nappy Change, Phenoxyethanol Symbol
04 June 2018 ANSM

No Phenoxyethanol on baby’s bottom: ANSM confirms recommendation pro

In 2012, ANSM (French National Agency of Medicine and Health Products Safety) recommended not using Phenoxyethanol in cosmetic products intended for the baby’s bottom. This recommendation had not been validated on the European level. But the French Agency has just published the results of the research done by a Temporary ...

Ink=ANSM junction
01 June 2018 ANSM

Injunction of the ANSM to the company La Compagnie des Sens

The ANSM has just sent La Compagnie des Sens an injunction to bring its Villeurbanne plant into compliance in the name of"major non-conformities and shortcomings". In question: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009 and ISO standard 22716 on Good Manufacturing Practices.

ANSM Injunction
18 March 2018 ANSM

Injunction of the ANSM to the company Pharmexence

The ANSM has just sent Pharmexence an injunction to bring its Lacoste plant into compliance in the name of"major non-conformities and shortcomings". In question: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009 and ISO standard 22716 on GMP.

CosmeticOBS - Observatoire des Cosmétiques
27 Feb. 2018 ANSM

Injunction of the ANSM to Laboratoires Omega Pharma France

It is in the name of"nonconformities and significant breaches" that the ANSM has just sent Laboratoires Omega Pharma France an injunction to bring its Châtillon establishment into conformity. The cause: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009, particularly in terms of claims and reports ...

CosmeticOBS - Observatoire des Cosmétiques
22 Feb. 2018 ANSM

Injunction of the ANSM to the company Centiflor

It is in the name of'major non-conformities and shortcomings' that the ANSM has just sent Centiflor (which owns the brands Huiles & Sens and MaCosmetoPerso) an injunction to bring its Entrechaux plant into conformity. The cause: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009 and ISO ...

CosmeticOBS - Observatoire des Cosmétiques
28 Dec. 2017 ANSM

Injunction of the ANSM to the company Eko Friendly

The ANSM has just sent Eko Friendly an injunction to bring its Neuville-sur-Saône plant into compliance in the name of"major non-conformities and shortcomings". The cause: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009 and ISO standard 22716 on Good Manufacturing Practices.

CosmeticOBS - Observatoire des Cosmétiques
17 Nov. 2017 ANSM

Injunction of the ANSM to the company Propos Nature

It is in the name of"nonconformities and significant breaches" that the ANSM has just sent Propos Nature a compliance injunction concerning its establishment at La Roque d'Anthéron. The cause: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009 and ISO standard 22716 on Good Manufacturing Practices.

CosmeticOBS - Observatoire des Cosmétiques
31 Oct. 2017 ANSM

Injunction of the ANSM to the Hyteck company (Aroma-Zone)

The ANSM has just sent Hyteck an injunction to bring its Cabrières d'Avignon plant into compliance in the name of'major non-conformities and shortcomings'. In question: several discrepancies relating to compliance with the requirements of Cosmetics Regulation 1223/2009.

CosmeticOBS - Observatoire des Cosmétiques
24 Oct. 2017 ANSM

Injunction of the ANSM to the S.F.F.C. pro

It is in the name of"non-conformities and important failures" that the ANSM has just sent to the Société Française de Fabrication de Cosmétiques (S.F.F.C.) an injunction to bring its Mourenx establishment into conformity. The cause: several discrepancies relating to compliance with the requirements of the ISO ...

CosmeticOBS - Observatoire des Cosmétiques
27 July 2017 ANSM

Cosmetic products to be mixed by consumers: an ANSM Opinion issued to manufacturers pro

In an Opinion issued to manufacturers on July 24, 2017, the French National Agency for Medicines and Health Products Safety (ANSM) reminds manufacturers and Responsible Persons that cosmetic products may be added to other cosmetic products, if, and only if a safety assessment was carried out in accordance with the ...

CosmeticOBS - Observatoire des Cosmétiques
20 July 2017 ANSM

Bioaromes cosmetics withdrawn from the market

ANSM has just published a decision to suspend the distribution and placing on the market of Bioaromes cosmetic products. To the French National Agency for Medicines and Health Products Safety, they are not compliant with regulations, both in terms of composition (they contain a preservative that is not in the ...

CosmeticOBS - Observatoire des Cosmétiques
04 June 2017 ANSM

ANSM meets with security evaluators pro

On Thursday 29 June 2017, the ANSM is organising an exchange meeting with the assessors in charge of the safety of cosmetic products. The objective is to bring together all these evaluators to share experiences and provide feedback on inspection findings in order to improve practices.

CosmeticOBS - Observatoire des Cosmétiques
25 March 2017 ANSM

Injunction of the ANSM to Phytomedica

It is in the name of"non-compliance and significant breaches" that the ANSM has just sent Laboratoires Phytomedica (PhytoNature brand) an injunction to bring its establishment in Aix-en-Provence into compliance: several deviations relating to compliance with the requirements of the Cosmetics Regulations and Good Manufacturing Practices.

CosmeticOBS - Observatoire des Cosmétiques
17 March 2017 ANSM

Two Neostem products just banned

ANSM has just published a decision to ban two products developed by Laboratoire Promicea: Neostem Serum and Neostem Pocket Lift. To the French National Agency for Medicines and Health Products Safety, they fit the definition of a drug, not a cosmetic product, and are likely to be hazardous for human ...

CosmeticOBS - Observatoire des Cosmétiques
09 March 2017 ANSM

Injunction of the ANSM to Cosinus & Servicosm

The ANSM has just sent Cosinus and Servicosm (cosmetic subcontracting companies) an injunction to bring their Dreux establishments into compliance in the name of"non-compliance and major shortcomings". In cause: several discrepancies relating to compliance with Good Manufacturing Practices.

CosmeticOBS - Observatoire des Cosmétiques
20 Feb. 2017 ANSM

Karanja oil: an ANSM Opinion issued to manufacturers pro

On February 9, ANSM published an Opinion intended for manufacturers on sunscreen products containing karanja oil. This warning reiterates the fact that it is not an authorized UV filter and its use to obtain a Sun Protection Factor is not legal.

CosmeticOBS - Observatoire des Cosmétiques
17 Feb. 2017 ANSM

ANSM injunction in Intuiskin

It is in the name of"non-compliance and significant breaches" that the ANSM has just sent Intuiskin a compliance injunction concerning its establishment in the 8th arrondissement of Paris. The cause: several product safety and GMP compliance discrepancies.

CosmeticOBS - Observatoire des Cosmétiques
16 Jan. 2017 ANSM

ANSM injunction to Nature&nbsp& Discoveries

It is in the name of"non-compliance and significant breaches" that the ANSM has just sent Nature & Découvertes an injunction to bring its Toussus-le-Noble establishment into compliance. The cause: several product safety and GMP compliance discrepancies.

The Observatory of Cosmetics
22 Aug. 2016 ANSM

Cosmetics in the ANSM activity report 2015 pro

At the beginning of August, the ANSM (Agence nationale de sécurité du médicament et des produits de santé) published its activity report for the year 2015. 139 pages that L'Observatoire des Cosmétiques has read for you, to highlight passages of interest concerning companies and cosmetic products.

The Observatory of Cosmetics
22 Aug. 2016 ANSM

Artificial nails: risks and precautions to take

The products and techniques used to apply or remove artificial nails are not risk-free for natural nails or the tissues around them. These practices are increasingly advised against in certain situations (pregnancy, surgery…). The ANSM (French National Agency for Medicines and Health Products Safety) has published a document to inform ...

The Observatory of Cosmetics
01 Aug. 2016 ANSM

ANSM: a wave of injunctions to cosmetic companies

At the end of July, the ANSM is updating its files and has just published no less than four decisions ordering the companies concerned to comply with Annex I of the Cosmetics Regulations concerning the report on product safety or with the ISO 22716 standard on GMP.

The Observatory of Cosmetics
26 April 2016 ANSM

The ANSM bans cosmetics JF Lazartigue manufactured in Trappes

This ANSM decision is dated 12 April 2016. It orders the suspension of the manufacture, export, distribution and placing on the market of cosmetic products manufactured at CTRC JF Lazartigue's Trappes site.

The Observatory of Cosmetics
10 Feb. 2016 ANSM

ANSM&nbsp: GMP inspections report pro

Between 2010 and 2015, an extensive inspection program was carried out at cosmetic manufacturers and manufacturing establishments by the Inspection Branch of theNational Agency for the Safety of Medicines and Health Products, with the aim of verifying the application by operators of the requirements relating to Good Manufacturing Practices (standard NF EN ISO 22716 ...

Download the ANSM Health Police Decision of 25 September 2015
30 Sept. 2015 ANSM

The ANSM bans the ingredients of Cargill France (Lannilis site) pro

This decision of the ANSM health police is dated September 25. It orders the suspension of the manufacture, packaging, placing on the market, distribution, export and use of raw materials manufactured by Cargill France at its Lannilis site, as well as the withdrawal of products, including cosmetics, that incorporate them into ...

Download the ANSM injunction to ICP France in PDF format
18 Aug. 2015 ANSM

pro

It is in the name of"non-compliance and significant breaches" that the ANSM has just sent the company ICP France (specializing in the development, manufacturing and packaging of cosmetic products) an injunction to bring its business into compliance. This is due to several deviations from the ISO 22716 GMP standard.

Download the ANSM injunction to SECOS in.PDF format
06 Aug. 2015 ANSM

ANSM injunction against SECOS pro

It is in the name of"non-compliance and significant shortcomings" that the ANSM has just sent SECOS (cosmetics manufacturer) an injunction to bring its activity into conformity. This is due to several deviations from the ISO 22716 GMP standard.

Download the Endoderma Relaxing Cosmetic Cream Batch Recall Form
30 July 2015 ANSM

Removal of Endoderma Relaxing Cosmetic Cream

ANSM (Agence nationale de sécurité du médicament et des produits de santé) announces the withdrawal of Endoderma's Relaxing Leg Cosmetic Cream. Reason: it contains Isobutylparaben, a preservative banned in Europe as of today.

13 July 2015 ANSM

ANSM : the 2014 activity report

On 8 July 2015, the ANSM published its Activity Report for the year 2014. After medicines, biological products, medical devices… The Observatory has searched in the"Other products" section for the few passages that concern cosmetics.

Download the ANSM injunction to BEAUTY NAILS in.PDF format
03 July 2015 ANSM

Injunction of the ANSM to the company BEAUTY NAILS

It is in the name of"non-compliance and significant breaches" that the ANSM has just sent BEAUTY NAILS an injunction to bring its cosmetic activity into conformity. In cause: missing or incomplete product information records and non-compliance with GMP.

Download the ANSM injunction to EXPERTOX in PDF format
26 June 2015 ANSM

Injunction of the ANSM to the company EXPERTOX pro

It is in the name of"non-compliance and significant shortcomings" that the ANSM has just sent the company EXPERTOX, whose trade name is"CERTl +" an injunction to bring its cosmetic activity into conformity.

Download the ANSM injunction to TECHNIC FRANCE in.PDF format
23 June 2015 ANSM

Injunction of the ANSM to TECHNIC FRANCE

It is in the name of"non-compliance and major shortcomings" that the ANSM has just sent TECHNIC FRANCE (on which Kemesys laboratories depend) an injunction to bring its cosmetic activity into conformity. The shortcomings noted mainly concern non-compliance with GMP.

The Observatory of Cosmetics
04 May 2015 ANSM

JF Lazartigue pinned by ANSM for non-compliance

DIP defects, lack of product safety assessment, inorganisation of cosmetovigilance, breaches of GMP… as many reasons which motivated the injunction to bring its cosmetic activity into conformity addressed by the ANSM to the company CTRC JF Lazartigue. Within 2 to 6 months.