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Home  ›  How To Register Cosmetic Product In Europe

How To Register Cosmetic Product In Europe

Written By Wednesday, June 15, 2022 Add Comment Edit

When it comes to placing a cosmetic & personal care product on the European market, the Cosmetic Regulation 1223/2009 has enforced several obligations. Notice with EcoMundo the 5 key steps that are necessary to commercialize successfully your cosmetic products on the European marketplace!

[Reading time ~ 15 min]

For most actors of the cosmetics & personal intendance products industry, the European Cosmetic Regulation no 1223/2009 enforces measures that accept to be fulfilled before placing a cosmetic production on the European market: appointment of a Responsible Person, creation of the Product Data File, labeling compliance, CPNP notification, etc.

Discover the 5 primal steps, recommended by EcoMundo's experts, to place your products on the European market.

  • Footstep ane: engagement of a Responsible Person
  • Step 2: control of the product'southward composition
  • Step 3: creation of the Production Information File (PIF)
  • Footstep 4: creation of compliant labels
  • Step five: CPNP notification earlier placing the product on the market

Step 1: the appointment of a Responsible Person

First major step of Regulation 1223/2009: every cosmetic brand must appoint a Responsible Person (RP), natural or legal, within the European Union, for each and every corrective product placed on the European market place.

What is a Responsible Person?

Definition: Natural or legal person established in the European Community acting for all the European countries at once. The RP can be a consulting firm (like EcoMundo), a manufacturer, an importer, or a benefactor.

Who can exist a Responsible Person?

  • The manufacturer established in the Community
  • The importer : each importer tin take the part of RP if the cosmetic product is manufactured outside the European Union.
  • The distributor : the distributor becomes RP if the product is placed on the market place under its proper name or brand, or if he modifies the production already on the market with the adventure to bear upon the product'south compliance with the Regulation.
  • A person established in the Community : the manufacturer or importer can appoint a third person established in the community, e.1000. a consulting business firm specialized in cosmetic compliance.

NB: In the instance where the manufacturer, the importer or the benefactor, engage a Responsible Person, the just ceremonial imposed by the Cosmetic Regulation 1223/2009 is that at that place has to be a written agreement between the parties.

What are your Responsible Person'south responsibilities?

The Responsible Person is:

  • The preferential point of contact with the government ; the authorities will prior turn to the RP to ask for information.
  • The product's compliance guarantor ; the Responsible Person is in charge of keeping the Production Information File for x years after the final batch of the product is placed on the market.
  • The product'south condom guarantor ; the Responsible Person ensures that the product is safe for human health.
  • Lastly, the Responsible Person is in charge of the respect of several obligations, such equally:
  • To proceed to cosmetovigilance [FR],
  • To check claims substantiation

And many other obligations, as of import equally these ones, which shall be further detailed in another article.

How to choose a trustworthy Responsible Person?

The Responsible Person can be a legal or natural person: because of the multiplicity of his/her responsibilities, it is often simpler to call on the services of consulting firms specialized in this field, i.east. cosmetology, toxicology, Pharmacy,etc.

Some service providers such equally EcoMundo tin can facilitate all steps to reach full compliance: formula review, artwork & claim review, production data file including rubber assessment and CPNP notification.

Pace ii: the review of the product's composition

The 2nd crucial step to validate before placing your corrective products on the market, is to review the composition or formula of your cosmetic product on a regulatory perspective, i.e against the Annexes of the Regulation.

To go a good grasp, let's take a look at some key definition, that yous can too acess hither => the Cosmetic Regulation

  • Cosmetic production: any substance or mixture intended to exist placed in contact with the external parts of the homo body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their advent, protecting them, keeping them in good condition or correcting body odors.
  • Cosmetic raw material: mixture of ingredients.
  • Cosmetic ingredient: a chemical element and its compounds in the natural state or obtained by whatever manufacturing procedure, including whatever condiment necessary to preserve its stability and any impurity deriving from the process used but excluding whatsoever solvent which may be separated without affecting the stability of the substance or changing its limerick.
  • Allergen: Ingredient susceptible to provoke an allergic reaction to sure subjects. Currentely in that location are 26 recognized allergens and those must exist labelled if their concentration exceeds the 0.01% threshold in rinse-off cosmetic products, and 0.0001% in go out-on products.

All ingredients don't take the same regulatory status!

Some ingredients are prohibited, restricted or allowed by the Cosmetic Regulation. You should make sure that the product that you want to place on the market is fully compliant with the Annexes of the Regulation outiling these restrictions.

What are the critical regulatory statuses?

Regulation 1223/2009 features several annexes that listing some of the regulated substances susceptible to be harmful to human wellness. There are three categories of ingredients:

a. Prohibited ingredients

Annex 2:

These prohibited substances are classified in Addendum II of the Regulation 1223/2009.

CMR substances:

CMR substances pictogram

The CMR substances (Carcinogenic, Mutagen, Reprotoxic) are listed in Annex VI of the CLP Regulation (EC No 1272/2008), and when they are of 2, 1A, 1B categories, they are prohibited.

They tin be authorized in fnished cosmetics products nether the following weather condition:

  • If they are compliant with the provisions related to the safety of food products, as divers past Regulation (Eu) No 178/2002.
  • In case there is no substance for exchange that is advisable after the assay of culling solutions.
  • If a request has been made for a particular use of the products' category, with a determined exposition.
  • When the substances have been assessed and judged safe by the SCCS for a use in corrective products (sole condition for category CMR two).

b. Restricted Ingredients

These substances are listed in Annex Three of the Cosmetic Regulation. These ingredients can exist used in corrective products merely nether the conditions described in the addendum (product type, purity criteria, percentage of maximal use,etc.).

c. Allowed Ingredients

Three functions of ingredients are listed by the Regulation: colorants, conservative agents and UV filters.

  • Immune colorants: they are listed in the Addendum 4 of Corrective Regulation (153 of them)
  • Allowed conservative agents: they are listed in the Annex V (59 of them)
  • Immune UV filters: they are listed in the Annex VI (29 of them )

These ingredients are authorized if they respect the Regulation's restrictions and depending blazon of products in which they are independent, the role of the body that is concerned, besides as the concentration of the ingredient in the product.

Is at that place a simple way to verify my cosmetic product'south limerick?

To check the compliance of the formula of your cosmetic product, y'all must compare the ingredients to the Annexes of the Regulation. It is important to note that this piece of work must be done on a regular basis, insofar as these annexes are updated several times a year (on an boilerplate of three months). It is crucial to conduct a continuous regulatory watch.

According to the complexity of your formulas, you may want to employ a software that will make the process quicker and more reliable.

For case, COSMETIC Manufactory a software designed by EcoMundo includes a functionality to review cosmetic formulas. The software tin can also assist with the drafiting of the so-chosen Product Information File, and the review of the labels, both key-steps to ensure complaince of cosmetics.

Step 3: creation of the Product Data File (PIF)

Another prerequisite to place your cosmetic product on the EU market is the constitution of the Product Information File (PIF). The PIF has to be made bachelor for the government, which tin consult it at any fourth dimension (electronic or paper). The drafting and the keeping of the PIF is mandatory even for cosmetic placed on the market place before the entry into force of the Regulation (2013).

What is the PIF?

The PIF (Product Information File) is a regulatory file which must be:

  • Kept for x years (from the date when the last batch of the corrective product is placed on the marketplace) past the Responsible Person.
  • Kept under electronic or newspaper format.
  • Written in an easily understandable linguistic communication for the authorities of the member states where it is archived.

What does the PIF must contain?

  • A clarification of the product: the Regulation does not impose a standardized grade, just imposes "a clarification of the cosmetic production which enables the product data file to be clearly attributed to the corrective product".
  • The Product Safety Study.
  • A clarification of the method of manufacturing and a argument of compliance with the Practiced Manufacturing Practices.
  • The proof of the effect claimed for the cosmetic product.
  • Information on any fauna testing performed by the manufacturer, its agents or suppliers, related to the development or safety assessment of the cosmetic product or its ingredients, including any beast testing performed to come across the legislative or regulatory requirements of tertiary countries.

a. The production's description

This description has to enable the reader to identify the product, without ambiguity, and to establish a articulate relation between the cosmetic production and its PIF.

b. The Production Safety Study

This report aims to establish a safety assessment of the cosmetic production on the ground of relevant information.

The production rubber report must be filled in accordance with Addendum I of the Cosmetic Regulation.

Ii singled-out parts:

  • Office A: Information about the safety of the cosmetic product
  • Part B: Safety assessment of the cosmetic product

Part A: Data about the condom of the cosmetic product

This part aims at gathering the necessary data to identify and clearly quantify, from the identified risks, the risks that your production may present for homo health.

The information will regard the raw materials, the manufacturing process, the packaging, the conditions of employ of the product, microbiology, the quantity used, the toxicological profile of the substances, etc.

You must, therefore, gather the following data:

  • Quantitative and qualitative composition of the cosmetic product
  • Chemical / physical characteristics and stability data of the cosmetic product
  • Microbiological quality
  • Impurity, traces, and information regarding the packaging textile
  • Normal and reasonably predictable use
  • Exposures to chemicals
  • Exposures to substances
  • The toxicological profile of the substances
  • Adverse effects and serious agin effects
  • Information on the corrective product

Part B: Safe assessment of the cosmetic production

What must include the safety assessment of a cosmetic product?

  • The conclusion of the evaluation: an indication regarding the safe of the cosmetic product.
  • The warnings and instructions of utilise on the label.
  • The scientific rationale: made on a case-past-example basis for each cosmetic product, verification of the presence of all required data, assessment of these data by an adept who analyses the relevance of the information.
  • The references of the person in charge of the cess and approval: proper noun and address of the person in charge of the condom cess, engagement and signature, etc.

c. Good Manufacturing Practices (GMP)

What are the Good Manufacturing Practices?

They come from the ISO standard 22716 published in 2007, providing the guidelines for the production, the storage, and the shipping of cosmetic products.

What should be mentioned in the PIF?

The PIF must incorporate a description of the manufacturing weather and the declaration of compliance with the ISO 22716 Good Manufacturing Practices.

Who takes care of the compliance with the Good Manufacturing Practices?

There is no licensed organism that can deliver a certification for the Good Manufacturing Practices, and the declaration of compliance with the GMPs tin be done internally or past a third company.

d. Claim substantation

The Claims must comply with Regulation No 655/2013 specifically drafted for the making of claims.

What is a "claim"?

Claims are text, names, merchandise marks, pictures and figurative or other signs shall non be used to imply that these products have characteristics or functions which they practice non have'.

The proofs of the claims may be: consumer perception test, clinical tests, bibliographic search, backdrop of ingredients that compose the production.

Examples of claims:

due east. Animal testing

Animal experimentation is prohibtied!

The testing ban on finished products applies since September 2004. Since this date you tin no longer test your finished product on animal on the EU market.

The testing ban on ingredients or raw materials applies since March 2009. Since this engagement, you lot can no longer test your ingredients and raw materials on animals on the EU market place.

Likewise, the marketing ban that applies since Marche 2009 for all human being health furnishings with the exception of repeated-dose toxicity, reproductive toxicity and toxicokinetics for the Eu market.

However, all historical animal information can even so exist used and be relied on for the drafting of cosmetic safety assessment or to fill up a data gap for toxicological endpoint such as skin irritation. Note that the bulk of ingredients used in corrective products are ingredients that are too used in many other consumer and industrial products, such every bit pharmaceuticals, detergents, food, etc. and animal testing may be necessary to ensure compliance with the legal frameworks applicable to these products. In those situations, the Commission considers that animal testing that has cleary been motivated by compliance with non-cosmetics related legislative frameworks should be tolerated for use in the cosmetics safety assessment.

What information must the PIF concord?

Regarding brute experimentation, the PIF must include data related to tests on animals that were carried out by the manufacturer, its staff or its providers.

Footstep 4: Creating compliant labels

Mandatory requirements on the characterization:

  • Name and address of the Responsible Person
  • State of origin
  • Nominal content
  • Date of minimum immovability or period-afterward-opening
  • Precautions & warnings*
  • Batch number
  • Production function*
  • Ingredients list

*Translation in the language of the export country is mandatory. Note that Austria, Bulgaria, France, Poland, Portugal and Slovakia, request full translation of the label, i.e. even the marketing content and claims.

Statements must appear visibly, legibly and indelibly on the label.

Which symbols should I use?

The 60 minutes-glass symbol to illustrate the Date of Minimum Durability (DOMD) when equal or beneath 30 months. The DOMD is defined past the stability test. You must add date almost the symbol

If the DOMD exceeds 30 months, the open up-jar symbol volition betoken the period afterward opening "PAO" defined by the combination of the stability examination and claiming exam.

The hand-in-volume symbol will indicate to the consumer that a card, tag or leaflet is enclosed with the product with more than regulatory information.


​

To salve time: use a software!

When information technology comes to ensuring labeling compliance , and considering that they must include some of the data independent in the Product Data File (ingredients list, claims, etc.), it can be very helpful to have all this data automatically compiled by a tool.

The Cosmetic Factory software offers you such features: for example, it can automatically generate a work document containing all the regulatory information that your label must include, making a much needed bridge between the regulatory and marketing teams.

Stride v: Notify using the CPNP portal

Last but not least, the Responsible Person must notify the European Commission via the CPNP portal.

What is the CPNP portal?

Cosmetics Products Notification Portal (CPNP) : CPNP is the online notification portal created for the enforcement of Regulation (CE) No 1223/2009 by the European Parliament and the Council of Cosmetic Products. Information technology is a website that Responsible Persons and Authorities tin use to access products' information

What are the regulatory requirements?

Regulation No 1223/2009 requires that any company willing to place a cosmetic product on the market notify online BEFORE doing and then.

What must be transmitted at the fourth dimension of notification?

  • Proper name and category of the product.
  • The proper noun and accost of the Responsible Person, plus contact details.
  • In instance of import, the country of origin.
  • The first country where the product will be placed on the market.
  • The presence of nanomaterials and CMR substances.
  • The corrective production'south formulation.
  • A compliant characterization with photo of the external packaging (if legible).

Just i notification is needed for all 31 countries of the European Economic Area (EEA).

To conclude

The five steps we described in this commodity are all mandatory to ensure compliance of your corrective products with the European regulation and enable you to place them on the market.

Detect our cosmetic software

To go far easier to ensure your products' compliance with the regulation, EcoMundo has developed a software called Corrective Factory.

This software assists you during all the key steps of placing your cosmetic product on the market. Its features handle the regulatory watch, the validation of your formulas, the review of labels and straight creates the Product Information File from your data.

Discover our European Cosmetics Regulation services

  • Regulation 1223/2009 services
  • Eu cosmetic compliance
  • Responsible Person for Europe
  • Formula review
  • Merits review
  • Cosmetic labeling services
  • PIF creation
  • Rubber Assessment
  • CPNP notification services
  • Cosmetic certification for Europe

Wish to know more about the compliance of cosmetic products ?

For more information, do not hesitate to contact Nataliya Muller or one of our experts!

Contact us

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How To Register Cosmetic Product In Europe,

Source: https://www.ecomundo.eu/en/blog/cosmetics-five-key-steps-market

Posted by: kellambligh1991.blogspot.com

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