PCR Regulatory

Are You Sure Your Natural Products Comply with EU Regulations – And Are They Legal?

Dr Mojgan Moddaresi of Personal Care Regulatory gave a talk at the recent Natural & Organic Products Europe 2015, explaining the legal steps cosmetics manufacturers both large and small must take before placing their products on the market. Alex Gazzola went along to listen in.

Distributors, manufacturers and importers must ensure when placing a beauty product on the market that the product is safe and complies with EU regulation 1223/2009, which came into force on 11th July 2013, and which harmonised regulation in all of the EU member states. The regulation strengthened safety requirements for cosmetic products and centralised notification of all cosmetic products placed on the market.

Responsible Person (RP)
An RP – a ‘legal or natural person’ – must be assigned for all cosmetic products, and it is their responsibility to ensure compliance with the relevant obligations set out in the regulation. Ultimate responsibility lies with them. They must be in the EC, have access to the product information file (PIF) and be adequately mandated.

Moddaresi stressed that the address of the RP should be on the back of the product’s packaging and that they should act on your behalf in the event of a recall. It is advisable to arrange a non-disclosure agreement with your RP.

Product Information File (PIF)
The PIF, which must be unique to each product, must include:
* A product description;
* A Cosmetic Product Safety Report (CPSR) (which includes both safety information, and safety assessment);
* Manufacturing procedure and evidence of compliance with good manufacturing practises (GMP);
* Where relevant and applicable, proof of any effect claimed for the cosmetic;
* Data on undesirable effects;
* Art work.

It is important that the RP keeps the PIF for ten years at an address within the EC which should be specified on the label, and be accessible for inspection by a local authority.

Cosmetics Products Safety Report (CPSR)
This is a technical report which should only be prepared by qualified experts with experience in the cosmetic industry, and who are professionally insured.

It is divided into two parts: Cosmetic Products Safety Information (such as microbiological challenge test, toxilogical profile of ingredients, reported undesirable effects), and Cosmetic Product Safety Assessment.

Cosmetic Products Notification Portal (CPNP)
This is a free-of-charge online notification system created for the implementation of Regulation (EC) No 1223/2009 on cosmetic products. Notification must be by either the RP or distributors. (Click here for the CPNP.)

Cosmetic Vigilance
It is down to the RP to be vigilant, monitor and report undesirable effects (such as allergic reactions) or serious undesirable effects (that might require hospitalisation) triggered by the cosmetic, once it has been launched on the market. Consumers have a right to report any reaction they experience.

Moddaresi closed by talking a little about claims made on cosmetics by manufacturers. She reminded us that cosmetics manufacturers are selling cosmetics – and not medicines – so are not permitted to make medical claims. Truthfulness is important. Do you claim that your product reduces wrinkles? You need evidence! Animal testing is banned in the EU: Is that leaping bunny really necessary? Probably not …

Personal Care Regulatory offers bespoke regulatory and compliance services to ensure brands can safely and legally launch their produced in the UK and throughout the EU.

For a consultation or for further information contact them on info@personalcareregulatory.eu or call +44 (0)1223 420252.


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