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. 



Cosmetic Notification between January 2012 to July 2013

in News

The New Cosmetic Regulation EC 1223/2009 will replace the current Cosmetic Directive 76/768/EEC and as such, the Notification requirements are aimed to be changed as well from country specific to the CPNP (Cosmetic Product Notification Portal) operated by the European Commission.

The question is what will happen during the transitional period of January 2012 till July 2013?

The following rules apply:

  1. Cosmetic Products introduced to the European market for the first time before the transition period and already notified under the Directive must be re-notified to the NEW CPNP during the transition period (between January 2012 till July 2013);
  2. Cosmetic Products to be introduced to the European market for the first time during the transition period and notified to the NEW CPNP during the transition period (between January 2012 till July 2013) do not need to be notified as well under the Directive (country by country);
  3. Cosmetic Products to be introduced to the European market for the first time after the transition period are required to be notified only to the NEW CPNP;

Reference to the above point 1 – Whereas point 68 of EC 1223/2009:

“In order to enhance the safety of cosmetic products and strengthen the market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, the product information file and notification, even if similar obligations have already been fulfilled under Directive 76/768/EEC.”

Reference to the above point 2 – Article 39 of EC 1223/2009:

“As from 11 January 2012, by way of derogation from Directive 76/768/EEC, notification carried out in accordance with Article 13 of this Regulation shall be considered to comply with Article 7(3) and Article 7a(4) of that Directive.”

Reference to the above point 3 – Article 13 of EC 1223/2009:

“Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission”

Cosmetic manufacturers and their designated Responsible Person shall need to plan ahead and create a strategy for the transition period based on the above rules and the availability of the Cosmetic Product Notification Portal – this will safeguard the compliance of the Cosmetic products and above all, ensure the safety of the user;

NEW Amendment to the Cosmetic Product Directive (referring to hair dying products)

in Industry News, News

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)

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Obelis Featured on Important Suppliers Directory

in News

Obelis European Responsible Person Center (O.E.R.P.C.) was recently featured on, an important USA portal dedicated to suppliers of products in the field of personal care. The website run by Personal Care Products Council, which is “the leading national trade association representing the global cosmetic and personal care products industry” presents Obelis’ high standard services for cosmetics related affairs in the European market:

  • EU Responsible Person
  • EU Cosmetic Notification
  • Cosmetic Product Information File
  • EU Safety Tests
  • EU Safety Assessment

ECORE Seminar by Obelis to be Launched at Cosmoprof North America

in News

ECORE is Obelis’ exclusive brand-name for seminars dedicated to the European Regulations concerning cosmetics. Under this name Obelis European Responsible Person Center (O.E.R.P.C.) has organized several events all over the world and this July, 23rd Obelis will hold an insightful seminar during one of the most important industry events: Cosmoprof North America, in Las Vegas.

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Obelis at Cosmoprof Bologna

in News

Cosmoprof Worldwide Bologna is one of the world’s most important international events in the beauty and cosmetics sector. Obelis has been a permanent visitor of this momentous exhibition for the last few years. In 2012, Obelis extended its activity and took part at Cosmoprof Bologna as an exhibitor.

Obelis presence at Cosmoprof (under the Belgian Pavilion) offered the platform to meet over 760 non–European exhibitors while over 100 meetings were conducted in Obelis’ booth during the 4-day event.

img_event_Cosmoprof Bologna 2012

The time for appointing a European Responsible Person is more critical than ever: The Cosmetic Regulation 1223/2009 will take effect from July 2013, by which date each and every cosmetic product must comply with the new and more stringent requirements implied by the above Regulation. In view of that, Obelis was more than ever, dedicated and committed to provide hands-on and personal guidance to any European & non-European Manufacturers; therefore, facilitating their EU market penetration but also and no less important, support the efforts in protecting the safety of the European users of cosmetic products.

Obelis Featured on Important US Community of Cosmetics Manufacturers

in News

Obelis was recently chosen to be featured as an international partner by one of the most dynamic web communities for small cosmetics manufacturers in the USA,

The website aims to equip manufacturers with the motivation and tools to build a successful business through tele-seminars, publications, mentoring and coaching, plus regulatory resources. In this respect, Obelis European Responsible Person Center was chosen as a trusted provider of services for those businesses looking to expand and export to European Union market.

Obelis can present businesses with a large array of services, such as:

  • Free product classification,
  • Information on the EU Cosmetic Regulations (EC 1223/2009 and Cosmetics Directive 76/768/EEC),
  • Guidance on cosmetic safety assessment,
  • Guidance on Product Information File (PIF),
  • Cosmeto-vigilance reporting and complaint handling coordination,
  • EU pre-market notification and many other.

Obelis presenting at US Commercial Services Webinar

in News

On February 29th, 2012, the U.S. Commercial Service will broadcast a webinar aimed at facilitating the U.S. cosmetic industry’s better understanding of the new European Cosmetic Regulation (1223/2009/EC) to repeal the EU Cosmetics Directive (76/768/EEC) on July 2013.

Obelis C.O.O, Doram Elkayam, will join the discussion on the new mandatory provisions of the EC Regulation, with a dedicated presentation on the EU Responsible Person and the New European Cosmetic Product Notification Portal (CPNP).
The webinar will cover central aspects of the new EU Cosmetics legislation, such as:

  • General provisions of the cosmetic regulation with a comparative analysis on the safety requirements between the Cosmetic Directive 76/768/EEC and the New Cosmetic Regulation EC 1223/2009;
  • The EU Responsible Person: roles and responsibilities;
  • The New European Cosmetic Product Notification Portal (CPNP);
  • The EU Safety Assessment (Toxicological Assessment): provisions & requirements;
  • With a time for FAQs on labeling & language requirements, Nano-Materials, Product Information File, Safety Tests and more.

Join the webinar, Wednesday, February, 29, 2012 (17:00 pm CET) to discover everything you need to know about the new EU Regulations on Cosmetics!

New Directive Regarding Teeth Whitening Products

in News

The European Commission has recently issued a new Directive (Council Directive 2011/84/EU) regarding tooth whitening products, under which these are classified as cosmetics products. These were formerly classified as medical devices under the Medical Device Directive (MDD 93/42/EEC). The new Directive also makes reference to restrictions and conditions of use of hydrogen peroxide in teeth bleaching products.

According to the new Directive, only dental bleaching products with less than 0.1% hydrogen peroxide may be sold on the open market in the European Union. Furthermore, products having between 0.1%-6% hydrogen peroxide content may only be sold to dentists, while all other tooth whitening products with more than 6% hydrogen peroxide are forbidden in the European Union, as an additional measure on product safety for the European consumers.

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Cosmetics with small packaging space

in Frequently Asked Questions & Guides, News

As the NEW Cosmetic Regulation EC 1223/2009 on Cosmetic products implies, a correct label is the gateway to placing your product on the European market. The Label is one of the core elements within a cosmetic Product Information File (PIF).

As presented in our article on Official EU Languages & Labeling Requirements, labels shall be eligible, visible and contain certain obligatory mentions;

However, how to apply adequate labeling when facing impossibilities due to practical reasons?

For instance; how will all the necessary labeling information be presented in case of mascaras or eye pencils, where the packaging space, is simply too small? 

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EU Regulation on Animal by-products affects Medical Devices & Cosmetics

in News

Regulation 1069/2009 and Commission Regulation 142/2011 does not apply to finished products under the respective scopes of the:

  • Scope of MDD 93/42/EEC
  • Scope of AIMDD 90/385/EEC
  • Scope of IVDD 98/79/EC
  • Scope of Cosmetics under the 76/768/EEC and repealing regulation EC 1223/2009,

Since they are not considered as “animal by-products not intended for human consumption”. Therefore; they are not subjected to any veterinary checks under Council Directive 97/78/EC that lays down the principles governing the organization of veterinary checks on products entering the Community from third countries.

To review the complete analysis under our publication page – Click here;

Safe Cosmetics Act of 2011 in the USA

in News

While in the European market in reference to cosmetic products is regulated and harmonized by the Cosmetics Directive 76/768/EEC and the NEW Cosmetic Regulation EC 1223/2009, the regulatory framework in the USA has not been as comprehensive and stringent till today.

The current US law in effect is from 1938 and has not been amended ever since, therefore, a shift in the US cosmetic policy is indispensable. In light of the ongoing product safety concerns within the ‘self-regulated’ US Cosmetic industry, The Safe Cosmetics Act of 2011 was introduced on June 24th, 2011 to United States House of Representatives.

The first and foremost objective of this new Act is to eliminate the harmful chemicals from cosmetic products and require companies to fully disclose their product ingredients for the very first time. The most important features of the SCA is to reduce the loopholes deriving from its outdated status and to give the FDA the authority to see that personal care products are free of harmful ingredients.

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Indie Beauty Network (IBN) Tele-Seminar a Great Success

in News

The Introduction to EU Cosmetic Regulation tele-seminar took place on October 27th 2011, in association with the Indie Beauty Network (IBN) & Obelis European Responsible Person Center (O.E.R.P.C.).

The tele-seminar consisted of a brief overview of Obelis background, experience and expertise, the “main players” involved in EU cosmetic compliance, the steps to compliance, Product Information File, the necessity of appointing a professional “Responsible Person”, and much more. This was followed by an extended, open question and answer period. Members unable to attend the live seminar submitted questions to Donna Maria (IBN Founder) by email, Facebook, and Twitter.

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Initial Cosmetic Webinar to Indie Beauty Members

in News

After much anticipation, Obelis will be presenting an Introduction to the European Cosmetic Regulation in association with Indie Beauty Network to IBN Members placing Cosmetic products on the market on October 27th, 2011.

Do you know the basics of selling in Europe? Join in on the conversation.

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The Responsible Person and Cosmeto-Vigilance

in News

The Responsible Person serves as the focal point for all necessary undesirable effect and serious undesirable effect communication. This includes contact with manufacturer, raw material supplier, importer, distributor end user, cosmetics professionals, health professionals, and the Competent Authorities. Effective communication is necessary in situations of serious undesirable effects which must be reported to all entities in contact with the product, as well as to the Competent Authorities where the effect occurred.

This notification of undesirable effects follows a set of guidelines which includes a causality assessment method, a report form and exchange of information between member-states authorities and the European Commission. The Responsible Person must handle all necessary communication immediately when an incident or crisis occurs.

Evidence of Good Manufacturing Practice

in Frequently Asked Questions & Guides, News

Evidence on Good Manufacturing Practice (GMP) is one of the essential requirements of the EU Cosmetic Regulation in Europe (EC 1223/2009) in light of product placement onto the European market. The GMP is only in reference to the entity which actually produces the product (the Producer). However, any entity placing cosmetic products onto the EU market under its name is required to have evidence of GMP (in reference to its Producers) as part of their Product Information File (PIF).

The producer may show evidence of GMP by obtaining a third-party certificate in reference to an on-site audit or they may issue a signed declaration which states they meet the criteria for Good Manufacturing Practices. One specific way to ensure the producer provides sufficient evidence is through the ISO 22716 standard which was adopted as a CEN standard (a European Standard). European regulation directs that the CEN/ISO Norm 22716 serves as presumption of conformity towards GMP.

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Cosmetic products vs. Medicinal products – Classification guidelines

in Frequently Asked Questions & Guides, News

Summary of the Guidance Document:

The “Guidance Document of the Demarcation between the Cosmetic Products Directive 76/768/EEC and the Medicinal Products Directive 2001/83 as agreed between the Commission Services and the Competent Authorities of the EU Member States” document attempts to provide guidance for the classification of products that may simultaneously fulfill the definition of a cosmetic product (as per the 76/768 Directive) as well as the definition of a medicinal product (as per the 2001/83 Directive).

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Obelis Launching EUCORE Workshop: Safety Assessment (Toxicological Assessment)

in News

EUCORE 5 is organized by Obelis European Authorized Representative Center (O.E.A.R.C.) together with the Federation of Israeli Chambers of Commerce and the full support, guidance & involvement of the Israeli Ministry of Health. 

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EU Market, Timeline & Harmonization

in Frequently Asked Questions & Guides, News


EU Market Timeline:

1. The European Community (1957)
2. Schengen Visa area (1985)
3. Unified European Market (1992)
4. “New Approach” (1985,1989,1993 & 2010)
5. The Euro born (2002)

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GMP for Cosmetic Manufacturers with sub-contractors

in Industry News, News

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).

Obelis International Offices Convention

in News

Obelis has launched its new International Offices and will be hosting EROMED at its home offices in Brussels, Belgium.

EROMED is a 2 day workshop exclusively aimed at Obelis International Offices (O.I.O) network – providing regulatory updates, knowledge & expertise and promoting Obelis European Authorized Representative Center (O.E.A.R.C.) services in their global markets.

The Workshop is organized by Obelis s.a European Authorized Representative Center & GiDoS s.p.r.l in association with INTERTEK. Presentations will be given by experts in their fields about the latest developments in the European Regulatory framework concerning Medical Devices, In-Vitro Diagnostics, Cosmetic products, and others, with a special emphasis on the recent implementations of the 2007/47/EC, as of March 21st, 2010 (MDD), and the EC 1223/2009, as of November 30th 2009 (Cosmetics).

EUCORE Workshop: GMP – EN/ ISO 22716

in News


The EN/ISO/ 22716 guidelines are intended to provide guidance regarding Good Manufacturing Practices for cosmetic products. These guidelines have been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. These guidelines offer organizational and practical advice on the management of the human, technical and administrative factors affecting product quality.

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EUCORE Workshop: The New European Regulation on Cosmetics

in News

Professional Seminar on: The New European Regulation on Cosmetics

The EUCORE seminar is a unique opportunity for importers of cosmetics to be exposed to European demands by European experts (e.g. representatives of the Belgian Ministry of Health and from the British Toxicology Lab INTERTEK) in light of the Israeli Ministry of Health will for alignment of the Israeli Law with the European regulation.

As such, Obelis European Authorized Representative Center (O.E.A.R.C) in association with the Israeli Chamber of Commerce, the Manufacturers Association of Israel, The Israeli Society of Chemists and the Cosmetics Division at the Ministry of Health have taken it upon themselves to organize this special event.

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Obelis launches “EUCORE” Workshop

in News

Obelis European Authorized Representative Center (O.E.A.R.C ) in Cooperation with the Manufacturers Association of Israel (the Cosmetic Department) and the Israeli Ministry of Health (Pharmaceutical Division) are proud to introduce the “EUCORE” Workshop aimed at the “New European Cosmetic Regulation – Provisions and Implementation”.

The workshop will be a one-time opportunity dealing with the requirements of the European Cosmetics regulation by European Experts in light of the Israeli Ministry of Health desire to harmonize and align its regulation with the European regulation.

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