Europe Reach Regulation For Various Sectors

Background

Cosmetics Directive - The Directive 76/768/EC has been governing the composition, labelling and packaging of finished cosmetic products in the European Union since 1976 and is now replaced by the Cosmetics Regulation (EC) 1223/2009.

Cosmetics Regulation - Regulation (EC) 1223/2009, on cosmetic products, entered into force on 11 January 2010. From 11 July 2013, it completely replaced Directive 76/768/EEC, on the approximation of the laws of the Member States relating to cosmetic products. Being common to all Member States, the Regulation sought to address the remaining gaps among national transpositions of the Directive and to streamline procedures.

This law was created to establish standards for cosmetic products that would be applicable in the EU-27 and 4 EFTA countries: Norway, Switzerland, Lichtenstein, and Iceland.

Inventory

• CosIng is EU's official database for cosmetic ingredients. It contains the list of ingredients used in cosmetic products, on the basis of information supplied by the
• It includes cosmetic ingredients listed in previous inventory of cosmetic ingredients and also the latest list of banned/restricted cosmetic ingredients in EU. The list can be accessed with an ingredient's INCI name or CAS
• There are total 27184 number of chemicals included in the CosIng inventory under Cosmetics Directive which gives information about function, Maximum authorized concentration, Condition of use (warnings), SCCS opinions, other limitations and
• The current data in the database can be found under the default status as “active”, whereas historic data have the status “not active”.

The cosmetic product is under a “Responsible person” and the authorities must be notified prior to the product entering the market.

• The CosIng database - makes it easier for companies
• (i) to find up-to-date information on substances needed to develop new cosmetics or to improve existing ones; and
• ii) facilitate market surveillance by the competent authorities and contribute to the safety of cosmetic products.
• The Cosmetics Regulation also contains positive and negative list of chemicals which should be checked before placing the product into market:
• prohibited substances
• restricted substances Þ preservatives
• Colorants
• UV-filters

GHS – Classification

• Regulation (EC) No 1272/2008 states that it applies to all substances and mixtures supplied in the European Community except where other community legislation “lays down more specific rules on classification and labelling”. The labelling of cosmetics is regulated by Regulation (EC) No 1223/2009.
• CMR: One of the biggest impacts that Regulation (EC) No 1272/2008 will have on cosmetic products is where it classifies substances as carcinogenic (Carc.), mutagenic (Mut.) or toxic for reproduction (Repr.). The cosmetic ingredients with CMR classification should be prohibited unless certain criteria are There should be a possibility to allow the use of substances classified as CMR 2 substances where, in view of exposure and concentration, they have been found safe for use in cosmetic products by the SCCS and are regulated by the Commission.

Regulation (EC) 1223/2009

Scope

Regulation (EC) 1223/2009 on cosmetic products covers cosmetics defined as:

• Any substance or mixture,
• Intended to be placed in contact with
  • The external parts of the human body (epidermis, hair system, nails, lips and external genital organs), or
  • Teeth and mucous membranes of the oral cavity
• With the any of the following as its main or exclusive purpose: cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors

Regulation (EU) 655/2013 is provided in Regulation (EC) 1223/2009, and therefore covers claims made in relation to cosmetics according to the same definition.

Main requirements under Regulation (CE) 1223/2009

Obligations under the regulation fall on a Responsible Person (RP), who must ensure compliance. The RP must be established within the European Union (must be a natural or legal person within the Union).

Thus, RPs have obligations in relation to the product itself (including labelling and claims) and relative to market placement notification and follow-up.

Product-related obligations

Products available on the market must be safe for human health when used under normal or reasonably foreseeable conditions of use.

Ingredient restrictions

To this end, RPs must comply with the ingredient obligations set out in the Regulation, as set out in its annexes (which are regularly updated)

• • Annex II – Prohibited substances
  • Annex III – Substances with restrictions (e.g. maximum concentrations)
  • Annex IV – List of colorants allowed (non-listed products can’t be used)
  • Annex V – List of preservatives allowed (non-listed products can’t be used)
  • Annex VI – List of UV filters allowed (non-listed products can’t be used)

Good manufacturing practice

Cosmetic products must be manufactured in accordance with the ISO 22716 standard (or any other equivalent standard). This is self-certified, but third-party certification is possible.

Labelling and claims

Labelling in the container and packaging must include the following information

• Name and address of the Responsible Person and country of origin for imported products ;
• Nominal content (with some exceptions for packaging containing less than 5mL or 5mg, free samples or single application pack) ;
• The function of the product (unless it is clear from the presentation) ;
• Date of minimum durability (when <30 months) or period after opening where the product is safe and can be used with no harm to the consumer ;
• Batch or reference number (if impracticable, it need only apply in the packaging) ;
• Precautions of use ;
• The list of ingredients in order of weight and in INCI name system preceeded by the term "ingredients" (substances or mixtures intentionally used, not including impurities in raw materials or subsidiary technical materials not present in the final product).

Where it is impossible to include the precautions and ingredients in the label, they must be included in an attached leaflet, label, tape, tag or card.

The language of the information (except the product name, ingredients and batch number) is determined by national legislation.

Claims

Claims must comply with Regulation (EU) 655/2013, which establishes common criteria for claims. These must be :

• Truthful
• Supported with evidence
• Honest
• Fair
• Informative and understandable

Claims referring to the fact that no animal testing has been carried out may only be done if no animal testing has been used to develop the finished cosmetic product, its prototype, or its ingredients.

Information-related obligations  

Under Regulation (EC) 1223/2009, a RP must compile information relevant to the product in a Product Information File (PIF), notify Competent Authorities when placing said product on the market, and develop a system to monitor and report on undesirable effects. A list of Competent Authorities for every Member State may be found here.

The Product Information File

The Product Information File is the key document needed before placing a product on the European market since it serves as evidence that the product is compliant to the Regulation. It gathers technical documents related to the finished product and its raw material for a Safety Assessor to perform a thorough analysis.  The PIF is divided into 6 sections: 

1. A description of the cosmetic product that enables the PIF to be attributed to the cosmetic product. 
2. The cosmetic product safety report (CPSR).
3. A description of the method of manufacturing and a statement on compliance with good manufacturing practice (GMP) according to ISO standards 22716. 
4. Where justified by the nature of the effect of the cosmetic product, proof of the effect claimed for the cosmetic product.
5. Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of countries outside the EU.
6. Information on the label.

The PIF must be kept by the RP for 10 years after the date of the last batch of the cosmetic product was placed on the market. The PIF shall be available to the Competent Authorities of the Member State where it is kept.

Notification on the CPNP

Prior to placing a product on the market, the following information must be submitted by the RP to the European Commission, using the Commission’s Cosmetic Products Notification Portal (CPNP) :

• The product’s category and its name or names
• Name and address of the RP where the PIF is available
• Country of origin (for imports)
• Member State where the product will be placed in the market
• Contact details of a physical person (who will be contacted in case of necessity)
• The presence of nanomaterials
• Name and CAS number of CMR substances
• Frame formulation
• Original labelling and a photograph of the packaging

Cosmetovigilance

In the case of serious undesirable effects, the RP and distributors must notify the Competent Authority of the Member State where the effect occurred, providing the following information:

• All serious undesirable effects that are known to the RP (or which might be reasonably expected to be known to him)
• Name of the product, enabling its identification
• Corrective measures taken (if any)

Competent Authorities

A list of Competent Authorities for every Member State may be found here

• Regulation (EC) 1223/2009 is enforced by a “Competent authority” in each member state,
• Each member state their own authority and enforcement
• Each Manufacturer/Distributor/Responsible person shall submit the information to member state authority and then each member state shall communicate to EU commission so as to harmonies the information at National

The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure proper application and due enforcement of this Regulation and shall transmit to each other, all information necessary with a view to applying this Regulation uniformly.

The Cosmetic Products Notification Portal (CPNP) is a free of charge online notification system created for the implementation of Regulation (EC) No 1223/2009 on cosmetic products. When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU.

The CPNP is accessible to :

• Competent Authorities
• European Poison Centres
• Cosmetic products responsible persons
• Distributors of cosmetic

Cooperation between competent authorities:

The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure proper application and due enforcement of this Regulation and shall transmit to each other, all information necessary with a view to applying this Regulation uniformly.

What is the institutional structure (for inventory, for GHS and for regulation) like ECHA in case of EU REACH?

The Cosmetic Products Notification Portal (CPNP) is a free of charge online notification system created for the implementation of Regulation (EC) No 1223/2009 on cosmetic products. When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU.

The CPNP is accessible to :

• Competent Authorities
• European Poison Centres
• Cosmetic products responsible persons
• Distributors of cosmetic

What are the fees for registration within this regulation?

There are no standard fees defined under this regulation. CPNP portal is a free of charge online system, where the user can submit their data, for free. The only fee that may be applicable is the service fees, in case the importer or manufacturer appoints a responsible person for submission of their data on the portal.

What is the penalty in case of violation of regulation?

Member States have laid down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The make sure that the penalties are effective, proportionate and dissuasive.

What are the data requirements is it tonnage specific?

There is no tonnage restriction on use of cosmetic product in the EU. Whatever quantity is placed on the market, has to be complied in accordance with the regulation.

The data requirement includes Product information file (PIF) which should be readily accessible to competent authority of the member state, this file should contain information as follows:

• Cosmetic Product Safety Report (CPSR).
• Animal
• Method of manufacturing (GMP).
• Proof of effect

What the target country and non-country implications :

The EU manufacturer, Importer or distributor has an obligation to comply with cosmetics regulation.

By default EU manufacture and importer are the Responsible person or they can designate third party Responsible person on their behalf.

Provisions for non-target country like appointment of OR etc.:

There are no implications for non-target country.EU Manufacture, Importer and distributor are the one who are obliged to comply under this regulation.

• Non-target country shall have to provide detailed information in order to prepare CSPR (Cosmetic product safety report).
• Description of the cosmetic product - category and its name, enabling its specific identification;
• Classification information of the chemical (CMR)
• In addition to the details mentioned above, the RP would also require the ‘Member State’ information in which the cosmetic product is to be placed on the market and the contact details of the

Manufacturer, the Responsible Person and GMP

The term ‘manufacturer’ has a wide definition under the cosmetics legislation and includes the entity which has a product designed or manufactured, and markets the cosmetic product under its name or trademark. Therefore, unless it has explicitly been mandated as such in writing, a contract manufacturer / filler will normally not be considered as the Responsible Person as it is providing services for a third party and not in its own name.  

It is the responsibility of the Responsible Person (RP) to ensure that every product placed on the EU market complies with the requirements of the Cosmetics Regulation (EC) 1223/2009. The RP's duties relate to all aspects regulated under the EU cosmetics legislation:

• Safety
• Good Manufacturing Practice
• Safety assessment
• Product Information File
• Sampling and analysis
• Notification
• Restrictions for substances listed in Annex III
• Substances classified as CMR substances
• Nanomaterials
• Traces of prohibited substances
• Animal testing
• Labelling
• Product claims
• Access to information for the public
• Communication of serious undesirable effects
• Information on substances

Regulation (EC) No. 1223/2009 Article 8 establishes ISO 22716 or equivalent as the requirements for good manufacturing practice (GMP).  

ISO 22716 is the GMP standard and provides organisational and technical guidance on the management of the human, technical and administrative factors affecting cosmetic product manufacture and product quality.  

The documentation system implemented should incorporate the following (this list is not exhaustive):  

• procedures  
• instructions  
• specifications  
• protocols  
• reports (such as complaint reports, deviation reports, investigation reports or recall reports)  
• methods  
• records  

Cosmetic product notification portal (CPNP)

Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the information to the commission on the online portal i.e., Cosmetic product Notification Portal.

Only one notification is necessary to access the EU market and its 31 countries. The notification must be done once for each product. There is no need for multiple notifications if the product has different shades. The exception to this is the notification of products containing nano-materials, which must be done six months prior to commercialization.

Other registration related requirements

Animal Testing Prohibited :

The Cosmetics Directive provides the regulatory framework for the phasing out of animal testing for cosmetics purposes. Specifically, it establishes:

• Testing ban - prohibition to test finished cosmetic products and cosmetic ingredients on animals;
• Marketing ban - prohibition to market finished cosmetic products and ingredients in the EU which were tested on
• The testing ban - on finished cosmetic products applies since 11 September 2004; the testing ban on ingredients or combination of ingredients applies since 11 March
• The marketing ban applies since 11 March

Responsible person has an obligation to communicate within supply chain on behalf of EU manufacturer and importer. Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.

Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the product information file is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures taken.

Responsible persons shall cooperate with these authorities, at the request of the latter, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, responsible persons shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of specific aspects of the product, in a language which can be easily understood by that authority.

Who can register? (Player) - Roles and responsibilities

As per the regulation only those cosmetic products can be placed on the market, for which a legal or natural person (Responsible Person (RP)) has been designated who will be responsible to meet compliance requirements within the regulation.

• Manufacturer within
• Importer (If product is manufactured in non-EU countries).
• Manufacturer or importer may designate a responsible person (RP).

Obligations of responsible person / compliance requirements: Pre-Market Obligation

• Compiling Product information profile (PIF).
• Checking ingredient used are of suitable grade.
• Producing Cosmetic product safety report (CPSR).
• Safety assessments by a qualified
• Ensuring labelling displays (accordance with CLP regulation).
• Applying claim appropriately and reviewing the supporting
• Notifying the products to the Notification Portal (CPNP).

Post-Market obligations :

• Sampling and
• Management of health related
• Undesirable Effects.
• Serious Undesirable Effects.

On-Going due Diligence :

• Keeping up to date with regulatory
• Responding to product

How GPC can help you ?

GPC can :

• Review your formulation 
• Test the physic-chemical properties of your product 
• Test the microbiology of your product 
• Perform a safety assessment 
• Perform regulatory monitoring 
• Give regulatory consulting