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Practical Guide on the 2013 European Cosmetics Regulation


Introduction to the Regulation New obligations from July 11, 2013

July 11, 2013: application of the new Regulation on cosmetic products (EC No 1223/2009) replacing directive (76/768/EEC). Regulation vs. directive? A directive is transposable in each European country’s national law, whereas, a regulation, which is more restrictive, is implemented as such in all EU countries. Countries concerned? The Regulation applies to the European Economic Area (EEA), which includes the 27 EU countries + Norway + Iceland + Liechtenstein. Overview of the new obligations introduced by the Regulation

• Responsible Person (RP): any cosmetic product placed on the EU market must be represented by an RP established in the EC.

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• Nanomaterials: they must now be notified, assessed and appear on the product labels.

• CMR substances: their presence is banned, unless an exceptional derogation has been granted (obligation since December 1, 2010).

• Notification: products must be notified via the CPNP before being placed on the market.

• Cosmetovigilance: serious undesirable effects must be communicated to the public and competent authorities.

• Packaging material: its composition must be known and assessed to ensure safety in case of content/container transfer.

• Sampling and analysis: must be reliable and reproducible.





Responsible Person Responsible Person (RP) definition: legal or natural person established within the Community, the RP acts for all European countries at once. The RP can be a consultant like EcoMundo, a manufacturer, an importer or a distributor. For the latter, two conditions exist:

• he places a product on the market under his name or brand, • he modifies a product already on the market in such a way that compliance with the requirements may be affected. The choice of the RP is crucial as he has a key strategic role! 1. Ensures the compliance of products placed on the market 2. Shoulders all the obligations described in the Regulation 3. Cooperates as a single point of contact with competent authorities

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What are the main areas of responsibility of the RP?

• • • • • • • • • • • •

Good Manufacturing Practices (GMP) Product safety assessement


Preparing and keeping the Product Information File Notifying the product via the CPNP Restricted substances


Non-use of substances classified as CMR Notifying nanomaterials Animal testing ban Labelling rules






Each n° refers to the sheet addressing this topic…


Product claims (publication of the common criteria in 2016) Communicating on serious undesirable effects


Communicating on substances with the competent authorities

Responsible Person

The choice of the Responsible Person is crucial for your activity



Product Safety Report Ensuring the safety of the product: is the Responsible Person (A) and the assessor’s (B) objective via two essential steps: A. Identifying the information required (all existing sources) B. Assessing and preparing a product safety report A safety report is mandatory for all products: • new ones being placed on the market for the first time, • products on the market, compliant with the directive.

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Part A – Information on the safety of the cosmetic product This information must be gathered to enable Part B: 1. Qualitative and quantitative composition of the product 2. Physical/chemical characteristics and stability of the product 3. Microbiological quality 4. Impurities, traces, information about the packaging material 5. Normal and reasonably foreseeable use 6. Exposure to the cosmetic product 7. Exposure to substances 8. Toxicological profile of substances 9. Undesirable effects and serious undesirable effects 10. Information on the cosmetic product Part B - Cosmetic product safety assessment 1. 2. 3. 4.

Assessment conclusion Labelled warnings and instructions of use Reasoning Assessor’s credentials* and final approval

* The assessor must hold a diploma (pharmacy, toxicology, etc.) recognized by a Member State.

Product Safety Report

Product Safety Report

It is an obligation for both new and existing products



Product Information File The file that gathers all the product’s key information

The PIF contains 5 main parts: 1. Description of the cosmetic product concerned 2. Product safety report 2 3. Description of the method of manufacturing and statement on compliance with Good Manufacturing Practice (see below) 4. Proof of the effect claimed for the cosmetic product 5. Data on any animal testing (see below) A better grasp of Good Manufacturing Practices (GMP)

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It is the European standard EN ISO 22716 published in 2007, which is recognized for the GMP standards description. This standard gives guidelines for the production, control, storage and shipment of cosmetic products. Key dates on the animal testing prohibition Sept. 2004 March 2009

March 2013

Prohibition to test finished cosmetic products Prohibition on ingredients or combinations, with exceptions (repeated-dose toxicity, reproductive toxicity and toxicokinetics)

Definitive prohibition even when alternative methods do not exist

Product Information File

What is the Product Information File (PIF)? It contains key information about the product (safety & manufacture) and must be kept for 10 years from the last placing on the market.



CPNP notification Essential step before any placing on the market

Cosmetic products notification web portal: before placing on the market, each product must be notified online via the CPNP. The following rule applies… 1 cosmetic product


1 Responsible Person


1 CPNP notification


27 European countries

To notify, the RP must provide all of the following information: • Category and name(s) of the cosmetic product • Name and address of the Responsible Person • Country of origin in the case of import • Member State where the product is first placed on the market • Contact details of a physical person to contact in case of necessity • Presence of substances in the form of nanomaterials 6 • Presence of CMR substances 5 • Formulation: can be provided according to a predefined frame formulation, according to exact or ranges of concentrations • Original labelling and photograph of the packaging 7 The Commission discloses certain information in order to: • monitor and analyze the market

• assess products • inform consumers • treat medically

Competent authorities Poison control center or similar bodies

CPNP notification

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…except in special cases where the product: • is imported from several countries: as many notifications, • has different shades: one notification can suffice.



Prohibited & restricted substances Pay attention to the possiblility to include certain substances

1. PROHIBITED substances

• Prohibited substances: listed in Annex II of the Regulation. To this day (April 2013), there are 1,328 prohibited substances.

• Substances classified as CMR* category 2, 1A or 1B are prohibited, unless all of the following conditions are met: compliance with the regulation on food safety absence of alternative substances particular use (product category and known exposure) positive assessment by the SCCS (only condition for cat. 2 CMRs)

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* CMR = Carcinogenic, Mutagenic or Reprotoxic. Annexe VI of the CLP regulation (EC No 1272/2008) lists the CMR substances. Corresponding CLP pictogram  2. RESTRICTED substances There are 4 types of restricted substances: Category



Restricted substances


About 150

Colorants allowed



Preservatives allowed



UV-filters allowed




Refer to the annexes for conditions: • product type • body parts • concentration

Prohibited & restricted substances

Hundreds of substances concerned: special conditions or close to zero-tolerance, the Regulation limits the scope of possibilities.



Nanomaterials To maintain safety, their use must be better regulated

Definition of a nanomaterial: insoluble or biopersistant, intentionally manufactured material with one or more external dimensions (or an internal structure), on the scale from 1 to 100 nm. Why take more precautions with nanos? Nanos have a higher surface/volume ratio. As a result, they have unique physicochemical properties that could be at the origin of human toxicity.

1. CPNP notification: the cosmetic product must be notified 6 months before its placing on the market, unless its nanoparticles comply with Annexes IV to VI of the Regulation. 2. Indication on the label: the nano should be part of the ingredients list (on the label or packaging of the product) and should be followed by the word 'nano' in brackets: titanium dioxide [nano]. 3. More detailed assessment: the Responsible Person must pay particular attention to the product’s safety assessment. What necessary information must be collected? The notification and assessment of safety require: a clear identification of the nanomaterial, its particle size distribution, an estimate of the quantity in the finished product, and also a toxicological profile, exposure conditions, etc. January 11, 2014 Awaited report from the Commission on the state of nano knowledge and the list of all nanos used in cosmetics.


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A cosmetic product containing a nano: what obligations?



Labelling & Packaging Get ready for the new labelling rules

A few definitions to start off with: Formulation also content or finished product

Receptacle also container or primary packaging

Packaging also secondary packaging

Mandatory information for labelling and packaging Name or business name and address: of the Responsible Person. Country of origin: for imported cosmetic products. Nominal content: weight or volume (unless exceptions). Date of minimum durability: (if <30 months) preceded by or by the words “best used before the end of”, or period-after-opening: preceded by the symbol essentially for products with a shelf-life of more than 30 months.

• Special precautions for use: at least those listed in Annexes III to VI of the Regulation and for professional products.

• Batch number of manufacture or reference: for traceability. • Function of the product: unless it is obvious. • List of ingredients: in descending order of weight (if ≥ 1%), then in disorder and last (if < 1%). The list of ingredients may only be indicated on the packaging. Note: information in indelible, easily legible and visible lettering

Labelling & Packaging

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• • • •



Serious undesirable effects Communicating them to the competent authorities is mandatory

Definition “undesirable effects”: harmful reaction for human health attributable to the normal use of a cosmetic product. Definition “serious undesirable effects”: that causes (temporary or permanant) functional incapacity, disability, hospitalization, congenital anomalies or an immediate vital risk or death.

The RP and distributors must notify to the concerned Member State’s competent authorities and provide: • all serious undesirable effects, which are known to them • the name of the cosmetic product concerned (for its identification) • the corrective measures they have taken, if any Note: “undesirable effects” that appear as being potentially serious are also concerned by these obligations.

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Notification to the competent authorities scenario Distributors

Competent authority (Member State concerned)

Responsible Person


Other competent authorities from the EU

(1) In direct contact with the Consumers and health professionals

authorities, the RP should be carefully selected. Take his scientific and regulatory expertise into account.

Serious undesirable effects

What obligations in case of serious undesirable effects?



EcoMundo Services Need a trustworthy Responsible Person?

A recognized expertise: Key actor in the REACH compliance since 2007, today EcoMundo provides its regulatory expertise and its scientific skills in toxicology and chemistry to the cosmetics industry. COSMETIC VALLEY: as a member of the world's leading perfumery cosmetics network, EcoMundo nurtures a network of international and well-respected partners. A single point of contact to cover ALL your obligations Companies concerned: • Your products are already on the EU market • You plan to place new products on the market

Comply now!

We ensure a cost-attractive and rapid compliance:


Pack « quick market access » Notification + Labelling


Product Safety Report Both collection & assessment


Product Information File Consisting of the 5 parts

Signature of an agreement between the two parties “EcoMundo – RP” services • All obligations charged to the RP • Direct contact with the competent authorities • Strategic regulatory watch of your products and substances

EcoMundo assists large corporations but also SMEs!

EcoMundo Services

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Responsible Person Service

EcoMundo as your RESPONSIBLE PERSON Contact your nearest office to receive a quote tailored to your needs

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FRANCE, Paris +1 778 231 1607 +33 1 83 64 20 52

The Pocket Cosmet'  

All you need to know about the new EU Regulation on cosmetic products.

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