News

Catalogue of nanomaterials finally published!

in News

After several delays, the European Commission has finally published on the 15th June 2017 the catalogue of nanomaterials used in cosmetic products which are currently placed on the market. Read more


Cosmetic Preservatives – What Changed ?

in News

Recently many preservatives have been banned or restricted in cosmetic products. One of the most widely used was the mixture Methylchloroisothiazolinone / Methylisothiazolinone (MCI / MI). This mixture was allowed for use in all cosmetic products up to 0,0015% (3:1). This is no longer the case. Read more


ECHA Launches Public Database of Chemical Substances

in News

 
 
 
 
 
 
 

17th of March 2017, the European Chemicals Agency (ECHA) launched a publicly accessible database with information on over 15 000 chemical substances. This database is aimed at researchers, regulatory authorities and businesses. Read more


Cosmetic Product Classification

in News

In order to ensure a product is indeed a cosmetic product, the product formulation, characteristics, sites of application and intended functions must match the definition of a cosmetic product as defined in the scope of Cosmetic Regulation EC 1223/2009, which came into effect in 2013.

Once the product has been found to match the definition of a cosmetic product (as per Art. 2 p.1a) the cosmetic product categories listed in regulation EC/1223/2009 (in preamble 7) need to be considered. The next step is then to outline how products can be grouped together as product families, thus determining the creation of the respective PIF.

Read more


EU Commission restricts the use of hair dyes and Benzophenone-3

in News

EU Commission restricts the use of hair dyes and Benzophenone-3


 
 
 
 
 
 
 
 
 
 
 
Last week, the EU Commission announced two amendments to the current Cosmetic Regulation (EC) No 1223/2009. Published amendments to Annex III and Annex VI of the Regulation restrict the use of hair and eyelash dye substances, as well as Benzophenone-3.

Amendment of Annex III regarding hair and eyelash dyes

In 2001, the Scientific Committee on Cosmetic Products and Non-Food Products (SCCP) conducted a study on the use of permanent hair dyes and the risk of bladder cancer. The study discovered a potential risk in the use of hair and eyelash dyes. As a result, the EU Commission has issued an amendment to the Cosmetic Regulation, restricting the use of such substances. The amendment lists all the updated requirements, including additional mandatory testing for genotoxicity and carcinogenicity.

Read more


Obelis “Success Story” in the Belgian Cosmetics Catalogue!

in News

belgian-cosmetics

Obelis has been listed in the official Belgian Cosmetics Catalogue 2016! The catalogue, published in September 2016 by the Belgian Federal Agency for Exportations, presents the most up-to-date insight into the Belgian cosmetics industry (its size, turnover, export rate) as well as lists of all the key players and stakeholders. Obelis, being one of them, received a special mention in the ‘Belgian Success Stories’ section, where an interview with Obelis CCO (Mrs. Sandra Ferretti) has been published. Read more


3 Leading Factors That Can Expedite Sales to Europe

in News

The EU Cosmetic Regulation EC 1223/2009, published in the official journal of the European Union on November 30th  2009 and introduced on July 11th 2013, requires all cosmetic products to apply a specific compliance process – this compliance process may take between 4-8 months on average. Read more


Obelis to organize the First International Congress on Cosmetics Regulations!

in News

obelisarticle2

Obelis, together with BioEvents, is organizing the first edition of International Congress on European Regulations and Compliance for Cosmetic (CRCC 2016). The congress will take place between 7th and 8th November, at the Hilton Prague, in Prague, Czech Republic. It will bring together cosmetics industry professionals from all over the world, interested in learning more about the EU compliance process for beauty products.

Read more


Revision of SCCS Guidance on the Safety of Cosmetics – What has Changed?

in News

Notes of guidance:

The latest edition of the “Notes of guidance for testing of Cosmetic Ingredients and their Safety Assessment” has been issued and closed for comments following the deadline of 8th of January 2016. This is a document issued periodically by the SCCS, with the purpose of improving the compliance of cosmetic products with the last amended cosmetics regulation (1223/2009/EC). The previous edition was issued in 2012, having seen since then several amendments, and new opinions have been published thereafter. All these modifications form the basis of a new revision. Read more


Fragrance Industry – The End of Animal Testing in Allergen Risk Assessment

in News

On the 16th of December 2015, during the third annual review of the IDEA Project regarding risk assessment methodologies processes and criteria to identify fragrance allergens of concern, the Fragrance Industry reaffirmed its commitment to finding suitable alternatives to animal testing to assess the potency of skin sensitizers. Read more


NEW SCCS opinion on o-Phenylphenol

in Industry News, News

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


EC identified essential principles in REACH data-sharing

in Industry News, News

On the 26th of January 2016 the new Regulation (EU) No 2016/9 entered into force. It defines extensively the terms of transparency, fairness and non-discrimination of data-sharing agreements for the registration of chemical substances according to the REACH – Regulation (EC) No 1907/2006. Read more


CoRAP 2016-2018 Published

in News

On October 28th, 2015, the European Chemical Agency (ECHA) has published its proposal to update the Community Rolling Action Plan (CoRAP) for 2016-2018. The final plan will be adopted in March next year, and it is expected that the Member States will evaluate 138 substances, 53 of which are newly selected. Read more


ISO 16128 – The future of natural and organic cosmetics

in News

For the past five years, the International Organization for Standardization (ISO) has been discussing harmonized criteria and definitions for natural and organic cosmetics. On the 11th November, the first part of the ISO 16128 – which defines the technical definitions and criteria for natural and organic cosmetic ingredients and products – was finally approved for publishing. Read more


Formaldehyde in Cosmetics – What You Should Know

in News

Formaldehyde has been recommended to be classified as a mutagen of category 2 (may induce heritable mutations) and a category 1B carcinogen (presumed human carcinogen) by the European Chemical Agency (ECHA), since December 2012. This reclassification is to be adopted from the 1st of January 2016 and is expected to have an impact on the nail hardening cosmetics industry, since this reclassification implies that formaldehyde is to be banned from cosmetic products, as per the 1223/2009/EC regulation. Read more


Nano-Hydroxyapatite – is it safe?

in News

On October 16th, 2015, the SCCS published an Opinion on the safety of Hydroxyapatite in its nano form. The opinion will be open for comments until January 8th, 2016. Read more


ZINC OXIDE: Approved as a UV Filter in Cosmetics by the European Commission

in News

On October 22, 2015 the European Commission Standing Committee voted to approve the use of Zinc Oxide (ZnO) as a UV filter in beauty products, in its nano and non-nano form. The Annex VI to the Cosmetic Regulation EC 1223/2009 will be updated accordingly, probably in early 2016.

Read more


NEW EC Request on the safety of Titanium Dioxide (nano) in sunscreens and personal care sprays

in News

On 14th September 2015, the European Commission requested a scientific opinion on the safety of the nano form of Titanium Dioxide (TiO2) when used as UV-Filter in sunscreens and personal care spray products. Read more


The Court of Justice Rules: Contact Lenses Do Not Fall Under the Cosmetics Regulation

in News

On the 3rd of September 2015, the European Court of Justice, delivering the case C-321/14, ruled that corrective color contact lenses do not fall within the scope of the Regulation (EC) No 1223/2009 on cosmetic products. This is despite the outer packaging possibly stating the following: “cosmetic eye accessory, subject to the EU Cosmetics Directive.” Read more


Hair Dyes – NEW SCCS Opinions

in News

On June 25, 2015, the SCCS published updates on the hair dyes: 2,6-Dihydroxyethylamino toluene, 2,5,6-Triamino-4-pyridimidinol sulphate and the new hair dye HC Yellow n.º 17 safety, covering the following points:

Read more


SCCS OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143) and HC Yellow No. 17 (B121). Deadline for comments: 28 October 2015

in News

At its 10th plenary meeting, the Scientific Committee on Consumer Safety adopted opinions on both 2,5,6-Triamino-4-pyrimidinol sulfate (CAS 1603-02-7) and HC Yellow No.17, which are used as hair dyes in cosmetic formulations. Read more


EC Proposes to Restrict the use of Methylisothiazolinone (MI): Public Consultation now Open.

in News

From the 29th of July 2015 to the 23rd of October 2015 public consultation on the restriction of the use of the preservative Methylisothiazolinone (MI) in cosmetics products is open. The EC proposes to ban MI in leave-on products and to wait for the final SCCS opinion on rinse-off and hair leave-on products, expected at the end of September 2015, before reducing the concentration from 100ppm to 15ppm in other products. Read more


EC Restrict Hair Dye Ingredients after Adoption of New Regulation (EU) 2015/1190

in News

On July 20, 2015 the European Commission adopted Regulation (EU) 2015/1190 thereby amending the Annex III to Regulation (EC) No 1223/2009. The new Regulation, binding in its entirety and directly applicable to all Member States, restricts the use of hair dye substances and was put forward by the Scientific Committee on Consumer Safety.

The Annex III to the Cosmetics Regulation contains a list of cosmetic ingredients that are only allowed in Europe if they comply with the restrictions imposed by the Annex. The new restrictions are the result of further efforts by the European Commission to control the potential health risks of hair dye ingredients in beauty products. Read more


SCCS to pronounce on the safety of four cosmetic ingredients

in News

During the last week of June 2015, the Scientific Committee on Consumer’s Safety (SCCS) were requested to pronounce on the safety of four different cosmetics ingredients of potential concern, as used in various cosmetics formulations: Read more


SCCS Opinion on “Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form)”

in News

Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form)

Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate nano forms are used in many leave-on and rinse-off cosmetic products, including skin, hair and nail products. However, these ingredients are not regulated in the Cosmetic Regulation (EC) No 1223/2009, although they are reported in the CosIng Database with several cosmetics functions. Read more


SCCS finally pronounces on α-Arbutin

in News

On the 27th May 2015, the Scientific Committee on Consumers Safety (SCCS) adopted the opinion SCCS/1552/15 on the safety of α-Arbutin, which is currently open for public comments until 22nd July 2015. This long-awaited opinion finally provides a clear conclusion on the safety of this cosmetic ingredient.

This is great news for the skincare sector and the beauty industry, which will see their concerns on this widely used skin-whitening cosmetic ingredient finally clarified. Read more


Opinion on Fragrance Ingredients Tagetes Minuta and T. Patula Extracts and Essential Oils (photo-toxicity)

in News

Photo-toxicity concerns over the extracts and oils from Tagetes spp.

The International Fragrance Association (IFRA) recommends the use of extracts and oils of Tagetes species is limited to up to 0.01% for the following situations:

“For applications on areas of skin exposed to sunshine – excluding bath preparations, soaps and other products which are washed off the skin – oils and absolutes obtained from Tagetes minuta L., syn. Tagetes glandulifera Schrank and Tagetes patula L. should not be used such that the level in the consumer product exceeds 0.01%.” Read more


The TTIP will not get banned ingredients into the EU

in News

In March 2015, the European Commission changed its position concerning cosmetics in the Transatlantic Trade and Investment Partnership (TTIP). This represents a major shift on the impact that the TTIP will have on the EU cosmetics market.
Read more


The ecological criteria for the award of the EU Ecolabel for rinse-off cosmetic products

in News

In December 2014 the European Commission published a long-awaited decision on the criteria required to award the Ecolabel for rinse-off cosmetics products. This document set down the basis and European standards to ensure that the same criteria are respected throughout the 29 Member States regarding the so-called ecologic cosmetics.
Read more


Cetylpyridinium Chloride – the next cosmetics preservative?

in News

What is Cetylpyridinium Chloride?

Cetylpyridinium Chloride is a well-known raw material with great potential in the prevention of microbial spoilage of various types of products including cosmetics. Despite these characteristics, Cetylpyridinium Chloride is currently not allowed for use as a preservative in EU cosmetic products, as it is not included in the Annex V – Allowed preservatives to be used in cosmetic products of the 1223/2009/EC Cosmetics Regulation
Read more


Sun Protection Factor Determination Guidelines

in News

What are sun protection products?

Sun protection products are classified as cosmetics in Europe. Their function is to protect the user from the UVB sun rays that can cause sunburn and may lead to skin cancer.
Read more


SCCS to clarify concerns on Arbutin, a skin-whitening cosmetics ingredient

in News

On 25th March 2015, the European Commission requested that the SCCS (Scientific Committee of Consumers Safety) elaborate on their verdicts on α-Arbutin, β-Arbutin and Deoxyarbutin, three chemical forms of Arbutin.

The request follows widespread concern over the safety of this ingredient, extensively discussed in the beauty industry and the EU cosmetics regulatory sector.

Read more


Verdict on Dichloromethane open for comments until May 22nd

in News

On the 25th of March 2015 at its 9th plenary meeting the SCCS adopted an opinion on dichloromethane due to recent concerns on its safety.
Read more


New NANO UV-Filter Allowed

in News

The European Commission’s Scientific Committee on Consumer Safety (SCCS) has published its verdict on the use of MBBT [2,2’-methylene-bis-(6(2H-benzotriazol-2-yl)-4- (1,1,3,3-tetramethylbutyl)phenol)] and concluded that the substance, used in its nano form as a UV-filter and at a concentration up to 10% in dermally applied cosmetic products, does not pose a risk of adverse effects in humans after application on healthy, intact skin. Read more


EC Issues Comprehensive Paper on Nanomaterials

in News

The European Commission, together with the University of West England (UWE), Bristol, published, in February, a new Thematic Issue called “Nanomaterials functionality”. In this paper, recent developments on nanomaterials applications are presented and the safety for humans and the environment is discussed. Read more


Obelis Blog: Rapex

in News

This edition of the Obelis Blog takes a close look at the Rapid Alert System, RAPEX – what it does, who can use it, how it works and why it is important for cosmetic products manufacturers. Read more


Fragrance ingredient found unsafe by SCCS

in News

Fragrance ingredient found unsafe by SCCS

In a meeting on 16 December 2014, the SCCS (Scientific Committee of Consumer Safety) adopted the SCCS/1541/14 opinion on the safety of the presence of vetiveryl acetate in leave-on and rinse-off type cosmetic products.

The opinion states that the available data is insufficient to properly assess the safety of the substance. However, there is evidence that vetiveryl acetate is a moderate skin sensitizer; additionally, genotoxic/mutagenic effects have been observed in an Ames test of vetiveryl acetate.

Therefore, the substance is not safe for use in cosmetics at the concentration limits proposed by the IFRA.

Consequently, the Committee has called for further information on the composition of the test substances used in the submitted toxicological studies. Read more


Calls for data on the potential toxicity of Styrene/Acrylates Copolymer, Sodium Styrene/Acroylates Copolymer and Colloidal Silver nanoparticles used in cosmetics products

in News

The consultation period for submitting relevant data on the use of “Styrene/ Acrylates Copolymer (Nano)”, “Sodium Styrene/ Acroylates Copolymer (Nano)” and “Colloidal Silver (Nano)” in cosmetics products to the European Commission is between the 25th of March 2015 and 30th of June 2015.

Member State Authorities, manufacturers of beauty products, producers of the substances concerned, and relevant cosmetics industry and consumers associations are invited to provide their feedback. Read more


Results of the Meeting of the Scientific Committee on Consumer Safety (SCCS) in March

in News

The Scientific Committee on Consumer Safety (SCCS) met on 4th of March 2015 in Luxembourg. The goal of the meeting was to prepare and publish new opinions to lead to a revision of the Annexes of the Regulation (EC) No 1223/2009.  Read more


CPNP release 1.5 successfully deployed

in News

On 22 December DG SANCO (Health and Consumers) announced the launch of improved features in the Cosmetic Products Notification Portal. The new functionalities include but are not limited to a transfer of products between Responsible Persons and a more efficient mechanism to download data for Poison Centres and Competent Authorities.
Read more


No need to be concerned about BPA, EFSA Confirms

in News

The European Food Safety Agency (EFSA) published in January 2015 a re-evaluation of BPA (bisphenol A) – an additive used in cosmetics packaging, which is totally banned in cosmetic products according to the EU cosmetics regulation. EFSA concludes that the substance poses no health risk to consumers of any age group (including unborn children, infants and adolescents) at current exposure levels.

Read more


NEW Opinions Upcoming After the Last Meeting of the Scientific Committee on Consumer Safety (SCCS)

in News

On the 20th of January 2015 took place in Luxembourg the last meeting of the Scientific Committee on Consumer Safety (SCCS). New opinions have been drafted by the Working Group on Cosmetics Ingredients  undertaking tasks directly linked to the question submitted by the Commission.

Read more


D4 and D5 Silicones UK’s Proposal Of Restrictions

in News

The UK Competent Authorities has expressed the intention to ask the European Chemicals Agency (ECHA) to limit the use of the two cyclosiloxanes D4 (Cyclotetrasiloxane) and D5 (Cyclopentasiloxane). Expected for January 2015, the first deadline for the UK Competent Authorities to submit the restriction proposal to ECHA has been extended until 17 April 2015.

Read more


Cosmetics animal testing ban conflict with REACH is solved

in News

The conditions of the animal testing ban in the EU were finally clarified last 27th October 2014, in a communication concerning this conflictive contact point between the REACH Regulation 1907/2006 and the EU Cosmetics Regulation 1223/2009, issued by the European Commission and ECHA (European Chemicals Agency).

The conflict

In the EU there is a total ban on animal testing for cosmetic products and its raw materials, which the Cosmetics Regulation 1223/2009 reflects in its provisions.

This ban affects two aspects of cosmetic products:

–          Testing Ban: any animal testing in cosmetic products or cosmetic raw materials cannot be conducted in the EU as of 11th September 2014 – following the ban on testing ingredients and their combinations in force since 11th March 2009

–          Marketing Ban: cosmetics tested in animals, or whose ingredients have been tested on animals, cannot be placed in the EU market as of 11th March 2013 – following a previous almost total ban in force since 11th March 2009 Read more


SCCS Opinions: Carbon Black, Titanium Dioxide and Zinc Oxide

in News

The Scientific Committee on Consumer Safety (SCCS)published recently the new Opinions SCCS/1515/13, SCCS/1516/13 and SCCS/1489/12, on the risk assessment of the nano-forms of Carbon Black, Titanium Dioxide and Zinc Oxide. The aim of these Opinions is to evaluate the impact on human health of these substances when used in cosmetics.

What are nanomaterials?

Nanomaterial means an insoluble material with one or more external dimensions or an internal structure, on the scale from 1 to 100 nm. Read more


Stricter labelling principles for sunscreens in Europe

in News

The efficacy of sunscreen products and the way this efficacy is being claimed are important public health-issues that lead the European Commission to both mandating the Scientific Committee on Consumer Safety (SCCS) to revise the use of UV filters and to ensuring the implementation of the sunscreens Recommendation 2006/647/EC of the 22nd of September 2006. This recommendation covers the efficacy of sunscreen products and the claimsrelated and though it is not a directive or regulation, it is the main document to consider when placing sunscreen products on the EU market.

The Recommendation aims to standardize and simplify the way sunscreen products are labelled throughout Europe in order to help the consumer to compare products and choose the right product for a given exposure and skin type.

The EC considers appropriate to set out examples of claims which should not be made in relation to sunscreen products, precautions that should be observed, and usage instructions that should be recommended for some of the characteristics claimed. Read more


How to write cosmetic claims

in News

More than one year has passed since the entry into force of the Regulation (EU) 655/2013 laying down common criteria for cosmetic claims appearing on packaging and other advertising materials. However, despite the information campaigns and the efforts made by the regulatory authorities to throw some light on this matter, there are still open questions on what claims are allowed on the packaging of cosmetic products.

Cosmetic VS Borderline products

Claims are one of the three main elements together with the function and formula defining a cosmetic product. Based on these elements, different categories have been established to englobe beauty and health products with similar characteristics. There are still some grey zones between cosmetics and medicinal products or other type of products, as it occurs with hygiene, sanitation and biocidal products. Read more


Irish Authorities restructure

in Industry News, News

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)

Img_news_Irish Authorities restructure

Visit HPRA’s Website

Why now?

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


NEW Biocide Regulation amended by EC

in News

On the 11th of March 2014, Regulation (EU) 334/2014 amending the NEW Biocide Regulation (EU) 528/2012 was published on the official journal of the European Union. The amendment was primarily intended to provide clarifications on the transitional measures between the former Directive (BPD 98/8/EC) and the NEW Regulation.

Why was (EU) 528/2012 amended?

A phase out provision was missing in the original text of the 528/2012 Regulation (published on May 22nd 2012 and came into force as of September 1st 2013). This meant that there was no period to allow existing stocks of biocidal products which did not comply with the new requirements to be exhausted.

Regulation 334/2014 rectified this situation by the correcting Article 52:

‘Notwithstanding Article 89, where the competent authority or, in the case of a biocidal product authorised at Union level, the Commission, cancels or amends an authorisation or decides not to renew it, it shall grant a period of grace for the making available on the market and use of existing stocks, except in cases where continued making available on the market or use of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment. The period of grace shall not exceed 180 days for the making available on the market and an additional maximum period of 180 days for the use of existing stocks of the biocidal products concerned.’

Impact on Cosmetic products

Annex V of the Biocide Regulation presents the Biocidal product types. The first group of product types is disinfectants (Main Group 1). Within this group, the first product type is products intended for personal hygiene – meaning, products intended to come in contact with the skin with the primary intention of disinfecting. Cosmetic products can (by their virtues and characteristics) fall under this product type and as such, require to be regulated as Biocides rather than as Cosmetics – in which case, compliance with the EC 1223/2009 will be replaced by compliance with Regulation (EU) 528/2012.

Biocide Regulation – Process to EU Market

Regulation (EU) 528/2012 is aimed at regulating products intended to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of an active substance(s) contained in the product. The Regulation aims to simplify the approval process of active substances and the authorization of products.

As in the 98/8/EC Directive, the approval of active substances takes place at Union level while the subsequent authorisation of the biocidal products takes place at Member State level. This authorisation can be extended to other Member States by mutual recognitions. The novelty of the (EU) 525/2012 Regulation in this regards, is the possibility of a new type of authorisation at Union level, thus reducing the administrative burden of the product authorization on a Member state level.

Specific online platforms (e.g.: R4BP 3 & IUCLID 5) have been created towards submitting applications and sharing data and information between the applicants, the European Commission, the EU Member state authorities and the European Chemical Agency.

The European Chemical Agency

The European Chemical Agency (ECHA) has a facilitating and coordinating role under the Biocide Regulation.

Img_news_NEW Biocide Regulation

The European Chemical Agency (ECHA) shall play a Coordinating role with respect to the approval process of active substances and the Union authorization. Companies may apply for the approval or the inclusion in Annex I of an active substance by submitting a dossier to ECHA and companies wishing to apply for an EU-wide authorisation in one go (Union authorization) may do so through the ECHA services. ECHA also offers technical and scientific support to the Member States, guidance and a helpdesk support.

If you would like to know more on the Biocide Regulation, please contact us.


EC Guidelines on Product Information File

in Industry News, News

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

  1. Quantitative & Qualitative composition of the cosmetic product
    • Each raw material of the composition is to be identified and quantified
  2. 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
  3. Microbiological quality
    • Microbiological quality of substances and mixtures
    • Microbiological quality of the finished cosmetic product
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. Undesirable effects and serious undesirable effects
  10. Information on the cosmetic product

PART B of the Cosmetic Product Safety Report (CPSR) – SAFETY ASSESSMENT

  1. Assessment conclusion
    • A product can be assessed as: ‘safe’, ‘safe with restrictions’ or ‘not safe’
  2. Reasoning leading to the Assessment conclusion
    • This must cover:
        • Safety Evaluation of substances & mixtures
        • Safety Evaluation of the Cosmetic product
  3. Warning & Precautions of use
    • Must appear on the Cosmetic  product label
  4. Assessor’s credentials
    • Name and address, proof of qualification, date and signature

Future Expectations

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.