On December 15th, 2015, the Scientific Committee on Consumer Safety (SCCS) revised its opinion from June 25th on o-Phenylphenol, concluding that lowering the maximum concentration limit for this substance in leave-on cosmetics products is recommendable. Read more
NEW SCCS opinion on o-Phenylphenol
EC identified essential principles in REACH data-sharing
Irish Authorities restructure
On July 1st 2014, the Irish national regulator for medicines, medical devices, cosmetics and other health products will be named HPRA (Health Products Regulatory Authority) instead of its former name – IMB (Irish Medicines Board)
Visit HPRA’s Website
According to the HPRA, the new name more clearly reflects the wider scope of functions and responsibilities assigned to the regulatory authority in reference to its initial status established in 1996, towards regulating only human & veterinary medicines.
As such, the HPRA is officially responsible to regulate the following range of sectors on the Irish market, including: cosmetics, medical devices, controlled drugs, clinical investigations and more. Read more
EC Guidelines on Product Information File
On November 25th 2013, the European Commission has published the Implementing Decision 2013/674/UE on Guidelines on Annex I to Regulation (EC) No 1223/2009, towards supporting the cosmetic industry to achieve compliance with the Regulation requirements.
The Guidelines list the data that should be available “as a minimum” with a cosmetic Product Information File – to be made readily available at the EU address of the Responsible Person:
PART A of the Cosmetic Product Safety Report (CPSR) – SAFETY INFORMATION
- Quantitative & Qualitative composition of the cosmetic product
- Each raw material of the composition is to be identified and quantified
- Physical/chemical characteristics and stability of the cosmetic product
- Physical/chemical characteristics of substances or mixtures
- Physical/chemical characteristics of the finished product
- Stability of the cosmetic product under reasonably foreseeable storage conditions
- The methodology used to determine the product’s minimum durability
- Microbiological quality
- Microbiological quality of substances and mixtures
- Microbiological quality of the finished cosmetic product
- Impurities, traces, information about packaging material
- Purity of substances and mixtures. Impurities: unintended substances in raw materials
- Evidence of the technical unavoidability of traces of prohibited substances
- The relevant characteristics of the packaging material in direct contact with the product
- Normal and reasonably foreseeable use
- Section essential to determine a relevant exposure scenario
- Warning and other explanations on the labeling should be consistent with the identified normal and reasonably foreseeable use
- Exposure to the cosmetic product
- To quantify the amount of cosmetic product coming into contact with the external part of the human body or the teeth and the mucous membranes of the oral cavity
- Exposure to the substances
- To quantify the amount of each substance coming into contact with the external part of the human body or the teeth and the mucous membranes of the oral cavity
- Toxicological profile of the substances
- To describe the toxicological hazard of each of the substances in the finished product
- To determine the potential exposure
- To draw up a risk characterization
- Undesirable effects and serious undesirable effects
- Information on the cosmetic product
PART B of the Cosmetic Product Safety Report (CPSR) – SAFETY ASSESSMENT
- Assessment conclusion
- A product can be assessed as: ‘safe’, ‘safe with restrictions’ or ‘not safe’
- Reasoning leading to the Assessment conclusion
- This must cover:
- Safety Evaluation of substances & mixtures
- Safety Evaluation of the Cosmetic product
- This must cover:
- Warning & Precautions of use
- Must appear on the Cosmetic product label
- Assessor’s credentials
- Name and address, proof of qualification, date and signature
Manufacturers and Responsible Persons should cooperate together to achieve complete and compliant product information files taking into consideration that EU Member state Authorities will rely on the above guidelines when conducting post market surveillance activities.
If you would like to know more on the Guidelines on the Product Information File, please contact us.
NEW Amendment to the Cosmetic Product Directive (referring to hair dying products)
The currently enforced Annexes of the 76/768/EEC Cosmetic Product Directive have been amend by the 2012/21/EU Amendment Directive on 3 Aug, 2012. The revisions are in reflection to hair dying products; and aiming at taking into consideration the most up-to-date scientific know-how.
These Annexes must be taken into account when evaluating the safety of a cosmetic product (e.g. Safety Assessment) and compiling a Product Information File (PIF)
GMP for Cosmetic Manufacturers with sub-contractors
According to EN ISO 22716 on Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices Article 12 – Subcontracting.
The GMP certificate is to be issued only to the producer (the one which actually produces the cosmetic products) and not to the manufacturer as it can be that a manufacturer does not actually produce anything (only owns the bands) hence there is nothing to certify.
The manufacturer will be required to properly document in its PIF (Product Information File) the evidence that his producer has obtained a GPM certificate for the production of his cosmetic products – that is sufficient in regards to the conformity with the NEW EC 1223/2009 European Cosmetic Regulation (and 76/768/EEC Directive).