CosmeticOBS - L'Observatoire des cosmétiques
July 3, 2015ANSM

Injunction of the ANSM to the company BEAUTY NAILS Add to my portfolio
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Download the ANSM injunction to BEAUTY NAILS in.PDF format

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.

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This injunction, dated 19 June 2015, follows an inspection by the ANSM carried out on the premises of the company BEAUTY NAILS on 19 and 20 January last.

The facts complained of

a) absence of safety evaluations for all BEAUTY NAILS products established in accordance with Annex 1 Part 8 of Cosmetics Regulation 1223/2009;
b) absence of compilation of information files for all BEAUTY NAILS products in compliance with(
c) High Class Clear - HC1 HC50 - Beauty Nails product formula incomplete in accordance with Annex 1 Part 8 of Regulation 1223/2009; (
d) Key responsibilities and training not defined in accordance with Chapters 3.3 and 3.4 of the harmonised standard NF EN ISO 22716 of January 2008 relating to good manufacturing practices for cosmetic products;
e) lack of separation, identification and/or protection and cleaning of all areas where good manufacturing practices must be applied in accordance with(
f) failure to identify, release and properly store raw materials and packaging items, and failure to reassess raw materials and bulk products in accordance with Chapters 6.4, 6.5, 6.7, 7.2.6.3 of Standard 22716;
g) documentation of production and control operations, compilation of batch records and release of unsatisfactory products in accordance with Chapters 7.2, 7.3, 8.2 and 17.3 of Standard 22716;
h) lack of control over subcontracting in accordance with Chapter 12 of Standard 22716.

The injunction

a) to have safety assessments in accordance with the requirements of Regulation 1223/2009 for all BEAUTY NAILS products placed on the market, within 6 months;
b) to compile the information files for all BEAUTY NAILS products placed on the market, within 6 months;
c) have the detailed qualitative and quantitative formulas in accordance with the requirements of Regulation 1223/2009 for BEAUTY NAILS products and in particular the product High Class Clear - HC1 HC50 - Beauty Nails, in a die-cast condition(
d) define responsibilities as soon as possible and train staff within 2 
months(
f) set up an identification system for all raw materials and packaging items, including the packaging and packaging materials, to ensure that they are identified and cleaned within two months;(c) the release of those same products and the revaluation of raw materials and bulk products arriving at toll stations(
g) ensure the traceability of production operations, draw up batch records and released the batch;(
h) have contracts with subcontractors and carry out audits of subcontractors within 6 months.

To go further
See Injunction n° 15COS109-INJ concerning the establishment of the company BEAUTY NAILS, located 144 route de Valentine in Marseille (Bouches-du-Rhône), to download below.

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