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Europe Reach Regulation for Various Sectors

Any chemical material/object containing chemicals placed into EU market need to comply with the REACH regulation. The chemical substances have the registration obligation whereas objects/articles containing chemicals have separate set of obligation.  

The Database for Substances of Concern In articles as such or in complex Products (SCIP) was established under the Waste Framework Directive (WFD) that aims to reduce hazardous chemicals in waste and promote safer alternatives. It is part of the EU’s waste legislation package, contributing to the EU's circular economy policy. 

The SCIP database ensures that the information on objects/articles containing Substances of Very High Concern (SVHC) is available throughout the whole lifecycle of products and materials, including at the waste stage.  

The following substances may be identified as SVHCs:  

  • Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation. 

  • Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH Annex XIII. 

  • Substances on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances. 

Once a substance is identified as an SVHC, it is included in the Candidate List. The inclusion in the Candidate List brings immediate obligations for suppliers of the substance as per Article 33(1) of the REACH regulation, such as: 

  • supplying a safety data sheet 

  • communicating on safe use 

  • responding to consumer requests within 45 days and 

  • notifying ECHA if the article they produce contains an SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w). 

From 5th January 2021, information about articles containing substances of very high concern (SVHCs) in a concentration above 0.1% weight by weight (w/w) on the EU market must be submited to ECHA. From this date onward all EU producers, Assemblers, importers, and distributors (inside EU only) must notify to the SCIP database. 

* substances of very high concern (SVHC) for human health and environment 

From 5 January 2021, article information should be communicated. To successfully notify your article to the SCIP database there are several categories for which information needs to be provided: 

Category 1: Information on Article. 

  • Information to identify the article (Identifiers): 

  • Article name (mandatory) 

  • Primary article identifier (EAN, GTIN, catalogue number, part number) (mandatory) 

  • Other names and identifiers (optional) 

 

  • Information to categorize the article (Categorization): 

  • Article category (CN/TARIC code) (mandatory) 

  • Production in the EU (required but not essential) 

 

  • Characteristics that help to identify the particle article 

  • picture, (optional) 

  • dimensions, (optional) 

  • color, (optional) 

  • weight (optional) 

 

  • Safe use instructions: how do you use this article safely? 

  • Option 1: Provide safe use instructions (free text)  

  • Option 2: Select “No need to provide safe use information beyond the identification of the Candidate List substance”  

  • Disassembling instructions (optional) 

 

  • Complex object component (only applies to complex objects): 

  • Linked article (add a link to an existing article or create a new article to link with this complex object) 

  • Number of units of the linked article in the complex object. 

 

Category 2: Concern elements (SVHC) 

  • Candidate list substance  

  • Concentration range, incl > 0.1% by weight and < 100% by weight 

  • Material category and/or Mixture category (EUPCS) 

  • Additional material characteristics. 

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  • They have 4 specific regulations on FCM based on a positive list of individual substances– 2004, amended from time to time.
  • (Plastics (10/2011/EU), recycled plastics (282/2008/EC) ceramics (Directive 84/500/ EEC), regenerated cellulose (Directive 2007/42/EC) and active/ intelligent packaging materials (450/2009/EC). For these DOC is mandatory.
  • Specific measures on substances are present – i.e. positive list of monomers and additives.

In the European Union (28 member states); all the FCMs fall into these European pieces of legislation.

  • Under this the manufacturers hold the responsibility that end products comply with Article 3.
  • They have specific regulations, well established regulatory systems and well-formulated regulations on FCM supported by scientific evidence.
  • Article 3 states that the FCM must not transfer substances to food particles under normal or predictable use, which:-
    • Are a threat to human health.
    • Cause an undesirable change in the composition of foods.
    • Bring about damage or interfere with properties of food.

The Framework Regulation No. 1935/2004 is the basic community legislation that covers all the Food Contact materials and articles. It basically defines what exactly are “Food Contact Materials” and sets the basic requirement for these materials. Materials that are contact with the food particles i.e., the packaging they come in, the materials that come in contact post the packaging i.e., the containers, cups we put them in, even the inner walls of the refrigerator can be considered also the cardboard packaging some eatables come packed in.

  • They have 4 specific regulations on FCM (out of 17no. listed in Annex I) based on positive list of individual substances– 2004, amended from time to time.
  • Plastics (10/2011/EU), recycled plastics (282/2008/EC) ceramics (Directive 84/500/ EEC), regenerated cellulose (Directive 2007/42/EC) and active/ intelligent packaging materials (450/2009/EC). For these DOC is mandatory.
  • Specific measures on substances are present – i.e. positive list of monomers and additives.                               

The basic reason behind declaration of these regulations is to make sure that all the materials that are intended to come in contact with the food must be sufficiently inert so that excess migration does not happen which avoids to possibility of endangering the human health or bring about an unacceptable change in the food composition which changes the organic properties of the food particles present in it.

The purpose of this Regulation is also to ensure efficient functioning of the internal market regarding the materials which can be used with/along food particles and also stating a benchmark regarding the safety measures and ensuring a high level of safety.

The stated regulations are applicable on all the materials, articles i.e. including all the intelligent food contact materials; which in their finished state: -

Are intended to be brought into contact with food, are already in contact with food and were intended for that purpose, can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use.

The stated regulations are not applicable to: -

Materials which are supplied as antiques, Covering or coating materials for e.g., material coatings covering the prepared meat products or fruits, which form part of the food, Fixed public or private water supply equipment.

Community legislation on FCM covers the following: -

1. Materials already in contact (packaging of prepacked food)

2. Materials intended to come in contact with food (cups, utensils)

3. Materials expected to come in contact (table top, refrigerator walls-etc.)

4. Materials which are to be reasonably expected to come in contact with food. [global]

Basic requirements are set to ensure safe food: -

  1. FCM shall not endanger human health
  2. FCM shall not change the composition of food in an unacceptable manner
  3. FCM must not change taste, odour or texture of the food
  4. FCM must be manufactured according to good manufacturing practice (GMP)      

Exceptions from 2nd and 3rd are made for active materials and articles

GMP is stated under framework regulations.

A few of the highlights of EU regulatory system include: -

  • Labelling i.e. for the consumers to be informed/known for :-
  • The suitability of the product for food contact for which fig 1.0 is used.
  • The person responsible for manufacturing or placing on the market of the product.
  • The instructions for the safe use of the product.
  • Means of identification of the product for traceability.

Traceability i.e. a broad requirement arising from general food law that ensures, for example, batch retrieval in the event of a necessity. Labelling can take several forms: on the goods itself, on supporting paperwork, or on a sign beside the merchandise at the merchant. The consumer must not be misled by the information supplied on the label. Also, that the producer is responsible for putting all the details stated above along/on the packaging as per the declaration of compliance.

The Framework Regulations enable the European Commission to establish the material's needs/requirements. The specifications of the basic guidelines of the framework regulations are among these requirements/needs. The requirements can be set for various types of materials including plastics etc.

Specific requirements composed of

  • Authorisation of manufacturing processes or certain materials
  • Rules On Labelling and Compliance testing

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post submission support and technical liaison with authorities. 

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1. Did the EU ban Single-use plastics?

Yes, the EU has banned single-use plastic products to reduce the danger these non-recyclable products pose to our environment.

2. What is the new EU Single-use Plastic Directive about?

The new EU Single-use plastic directive is a further clarification of guidelines made by the European Commission on the regulation of single-use plastics in the European Union. This directive applies to all member states within the EU. This new directive was issued on 31st May 2021, and it is what we refer to as an explanatory manual with detailed examples of products included or excluded from this regulation.

3. When is the new directive’s deadline?

The Single-Use Plastics Directive (SUPD) was approved in May 2019, and by 3rd July 2021, the ban on single-use plastic products and marking requirements will come into force.

4. Are all plastics referred to as Single-use plastics?

No. According to the directive, plastics refer to materials that consist of polymer to which additives or other substances might have been added. Also, this can function as a primary structural component of final products, excluding natural polymers that have not been chemically modified.

Also, Single-use plastics are products made with plastic and used one time before being thrown away: no hope of reusing or recycling them. Single-use plastics are also known as ‘disposable plastics’.

5. What are the marking requirements provided by the directive?

From 3rd July 2021, all single-use plastic products placed in the market will have a marking, either on the packaging or the product itself. This marking only applies to the products that were listed in part D of Directive 2019/904. These products are sanitary towels, tampons, tampon applicators, wet wipes, tobacco products, and cups for beverages. Read more here.

6. Who are the affected parties?

The EU directive on Single-use plastics applies to all member states within the EU. However, non-EU countries are not bound by this regulation at all.

7. Which Single-use Plastics are specifically banned?

Here is a list of the banned single-use plastics:

  • Plastic straws
  • Plastic plates and cutlery
  • Beverage stirrers
  • Balloon sticks
  • Cups, food, and beverage containers made with expanded polystyrene
  • Products made of oxo-degradable plastic
  • Plastic water bottles
  • Plastic shopping bags

Although there are some significant plastic product exemptions, they are food containers that require further preparation of the food before it can be consumed, beverage cups & lids, and plastic bottles of over 3 liters.

To get a complete list,contact us at compliance@gpcregulatory.com

8. Why EU Single-use Plastic Directive?

Plastic now makes up 80 to 85% of marine litter, and of this, 50% are single-use plastics. The main objective of SUPD is to reduce and further prevent the impact these plastic products have on the environment, especially our human health and aquatic environments. It will also help the Member States have an extensive reduction in the consumption of these products by 2026, 2022 being the base year, that is, the first year in the years to follow.

9. What other options do food manufacturers and retailers have as replacements for plastic spoons used with single-serve containers?

Starting from 3rd July 2021, only cutleries approved by the directive will be allowed in restaurants, events, and retailers. The approved ones include paper and wooden cutleries that have no poly in the board or coating.

10.What is the next step to take (if there is any action point (s)?

  • Yearly report by member states to the European Commission. 77% of single-use plastic products in the market must be recycled by 2025, and 90% of it by 2029.
  • Member States need to put in place measures that will guarantee that single-use plastic products are no longer placed in the market starting from 3rd July.
  • Member States should see to it that affected products are replaced with affordable alternatives.
  • According to the list provided by the directive, Member States must ensure that concerned single-use plastic products placed in the market bear a marking either on them or their packaging.

Single-Use Plastics Directive (SUPD)

On the 31st of May 2021, the European Commission released a new directive on single-use Plastics. The new EU Single-Use Plastic Directive aims to make further clarifications about plastic products that fall within that category and give further explanation about its regulations and policies. 

The new directive further mentions the reporting format to be used by member states and the deadlines for submitting their reports to the commission. The directive applies to every product considered as single-use plastic within the EU.

By 3rd July 2021, the ban on single-use plastic products and marking requirements will come into force.

GPC prepares a summary report for your reference. Download it here

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European Unions (EU) Registration, Evaluation, Authorization (Restriction) of Chemicals (REACH) Regulation

REACH is a regulation of the European Union, adopted to improve the protection of human health and environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.

REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.

If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.

REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance.

ECHA receives and evaluates each registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA's scientific committees assess whether the risks of substances can be managed.

Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorisation.

 

REACH

Registration Process :

To minimize animal testing and data fee for each registrant, REACH encourages data sharing among all registrants by the joint submission of registration data to ECHA. The main principle of REACH is “one substance, one registration”.

During joint submission process, one of the member among the manufacture of same chemicals nominate himself as lead registrant and the lead registrant or REACH consortium will do most of the work such as data collection, development of technical dossier and Chemical Safety Report (CSR), and submission of joint registration dossier to ECHA. Other co- registrants only need to pay the lead registrant or consortium a fee to refer to the joint registration dossier and then prepare the individual part of the registration dossier in IUCLID6.

REACH TIMELINE :

Post 31st  May’2018, Deadline all chemicals are treated equally and chemicals which were not registered within REACH with European Chemical Agency will not be allowed to be marketed or manufactured within EU.

 

Registration Dossier:

A registration dossier consists of two parts: Technical Dossier and Chemical Safety Report.

1. Technical Dossier
  • Identity of manufacturer/importer;
  • Identity, volume and identified uses of substance;
  • Classification and labelling;
  • Study report and robust study summaries according to Annex VII to X (physiochemical, toxicological, eco-toxicological properties, );
  • Testing proposal;
  • Statement whether tests have been carried out on vertebrate animals;
2. Chemical Safety Report (> 10 ton per year)
  • Human hazard assessment, physicochemical properties assessment, environmental hazard assessment and PBT/vPvB assessment;
  • Exposure Scenario is required if classified as dangerous or PBT/vPvB; Ÿ operational conditions and risk management measures for each use; exposure estimation

The total registration costs mainly consist of three parts:

Data fees paid to lead registrant or Consortium to purchase letter of access to refer to the common parts of registration dossier. The fee is tonnage dependent. Data fee varies from substance to substance. It is fixed by consortium or lead registrant. It is also tonnage based.

OR consultancy fees paid to OR to advise the whole registration process and prepare the individual part of registration dossier in IUCLID 6. The service fee covers SIEF/consortium communications, data gathering, IUCLID 6 dossier preparation and submission.

ECHA fees paid to European Chemical Agency. The fee is dependent on the annual tonnage of the substance and company size. Small and medium-sized enterprises (SME) enjoy discounts on ECHA fees (Euros).

Roles and responsibilities of REACH Only Representative :

In accordance with the Article 8 of REACH, the OR takes on the obligations of importers under REACH, in which case importers will be regarded as downstream users (thus do not need to register). Those obligations include:

  • Maintain pre-registration /registration data (company identity, annual tonnage, etc.) submitted to ECHA through REACH-IT.
  • Communicate with the downstream users (EU buyers).
  • Represent Non-EU company in SIEF/Consortium after pre-registration and keep them informed of the latest progress of SIEF/Consortium.
  • Supply Safety Data Sheets or transmit SDS along the supply chain and keep information on the supply of the latest update of the SDS.
  • Communicate with EU importers and regulatory authorities and issue necessary documents to ensure REACH compliance.
  • Keep an up-to-date list on the inventory of importers and the tonnage covered for each of these importers and keep the above information for at least 10 years and provide it to enforcement authorities upon request.
  • Registration, notification and authorization of substances (additional contract needed).

Substances exempted from the REACH Regulation

  • Radioactive substances
  • Substances under customs supervision
  • Substances used in the interest of defence and covered by national exemptions
  • Waste
  • Non-isolated intermediates
  • Transported Substances

Substances exempted from registration

  • Substances included in Annex IV of the REACH Regulation
    • Annex IV lists a number of substances for which it is understood that sufficient information is available to consider them as causing minimum risk to human health and the environment. These substances are typically of natural origin and the list of exempted substances includes, for example, water and nitrogen.
    • The list is largely based on the exemptions from Regulation (EEC) No 793/93 on risk evaluation of existing substances, although more substances were added. The registration exemption applies to the substance as such, not to a particular use.
  • Substances covered by Annex V of the REACH Regulation
    • Annex V lists thirteen broad categories of substances for which registration is deemed inappropriate or unnecessary. The registration exemption applies to the substances as such, if they meet the conditions for the exemption which are given in the particular category of Annex V.
    • Certain substances that are adequately regulated under other legislations, like substances used in food, animal feed, or in medicinal products, where the relevant criteria are met. Quantities of the same substance used for other uses than food, animal feed, and medicinal products are not exempted from registration.
  • Polymers are exempted while the monomer substances or any other substances they consist of must be registered provided certain conditions are fulfilled.
  • Recovered substances that are already registered
  • Re-imported substances
  • Substances used in product and process orientated research and development (PPORD)

For each category mentioned above, there are specific conditions under which the exemptions from registration under REACH apply, which need to be fulfilled to benefit from the exemption.

The European Chemicals Agency (ECHA) is an agency of the European Union which manages the technical and administrative aspects of the implementation of the European Union regulation, REACH. The Agency contributes to a well-functioning internal market and the innovation and competitiveness of the European chemicals industry.

ECHA develops independent scientific and technical opinions and takes binding decisions to ensure that chemical companies comply with European law. The Agency plays an important role in reducing chemical pollution in the EU. Together with the EU Member States and the European Commission, ECHA ensures safer chemicals use in Europe by improving the available data, disseminating and checking it, as well as proposing risk management measures when needed. The Agency also contributes to sustainability and circular economy.

An independent Management Board governs the Agency. It is composed of representatives from EU Member States, the European Commission, the European Parliament, and stakeholder organisations.

The registration obligations under EU-REACH apply to EU manufacturers and importers of substances on their own or in mixtures in quantities of 1 TPA or more. Furthermore, they apply to EU producers and importers of articles in case that the article contains a substance in quantities over 1 TPA and the substance is intended to be released under normal or reasonably foreseeable conditions of use of the article. The registration obligation does not apply to downstream users or distributors.

The registration obligations of importers can be taken over by an Only Representative (OR) established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU.

Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third-party representative for all proceedings involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of the manufacturer, importer, or downstream user who has appointed the representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users.

The size of the authority fee depends on the type of submission. The fee for registration can be found in Table 11. Fee reductions further apply to MSMEs (micro, small, and medium enterprises). The criteria for MSMEs is given in Table below.

Registration Authority Fee under EU-REACH

Tonnage Band (TPA)

Micro size

Small size

Medium size

Large size

1-10

€ 65

€ 457

€ 848

€ 1304

10-100

€ 175

€ 1227

€ 2279

€ 3506

100-1000

€ 469

€ 3282

€ 6094

€ 9376

> 1000

€ 1264

€ 8846

€ 16428

€ 25274

 

Criteria for MSME under EU-REACH

Category

Headcount

Annual Turnover

Annual Balance Sheet Total

Medium

< 250

≤ € 50 million

≤ € 43 million

Small

< 50

≤ € 10 million

≤ € 10 million

Micro

< 10

≤ € 2 million

≤ € 2 million

When declaring SME (micro, small and medium enterprise) size and claiming the SME fee reductions, a registrant must upload a complete set of supporting documentary evidence to ECHA.

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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.

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)

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

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  

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
Obligation for supply chain communication How it will be done and who all are responsible ?

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.

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 

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According to the European Commission (EC), nanotechnology is a key enabling technology (KET). It is an enabling technology that has applications in a wide range of industries, including chemicals, consumer goods, health, energy, and the environment. As a result, the European Union's (EU) regulatory framework, which is made up of various pieces of horizontal and sector-specific law expressly or implicitly encompasses nanomaterials (NMs).

The word "nanomaterial" has been defined in several regulatory papers in the European Union, including an overall nonbinding recommendation made by the EC in 2011 and several sector-specific pieces of legislation. The latter have either incorporated the overall definition established by the European Commission or utilise a dedicated and, to some degree, separate meaning of the word.

European Chemicals Agency (EU)

The European Chemicals Agency (ECHA) works closely with the OECD by participating in and participating in ongoing international regulatory activities such as the OECD Working Group on ENM. ECHA houses the EU Nanomaterials Observatory and the Nanomaterials Expert Group (ECHANMEG), and this advisory group assists in the implementation of the ECHA Nanomaterials Work Plan, 2016, 2018. Provides scientific and technical information and advice on issues related to the implementation of REACH methods related to ENM. No ENM exposure limits have been established for this agency and are only recommended by the European Union.

The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH, 2018) is an EU regulation created to protect human health and the environment from the risks posed by chemicals. REACH applies to substances on the nanoscale according to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 and the general provisions of REACH apply.

All chemicals covered by REACH must be registered in order to be lawfully produced or imported into the EU. Manufacturers and/or importers must provide information on both human health and environmental consequences, as well as hazardous nanoforms – an assessment of exposure throughout the life cycle – as part of their registration, depending on the amount placed on the market.

The same rules apply to nanomaterials. When chemicals have hazardous qualities, the Classification, Labelling, and Packaging Regulation (CLP) requires them to be reported to ECHA as well as labelled and packed so that they may be used safely.

Companies should be upfront in their REACH registration, explicitly indicating how the safety of nanoforms has been handled, as well as what actions are required to appropriately limit the possible danger. Companies can get more help from ECHA guidance materials on how to identify and report the attributes of their nanoforms.

Directives are primarily used in the EU to enact environmental, labour, and consumer protection legislation. If nanoparticles represent a risk to the environment, employees, or consumers, the generic regulations established by law apply to nanomaterials in the same manner that they do to other forms of a chemical.

Because REACH and CLP apply to nanomaterials, industry and authorities must fulfil their obligations and carry out their tasks in accordance with the various REACH (e.g., registration, evaluation, authorisation, and restrictions) and CLP processes (e.g., classification and labelling) for nanomaterials, just as they do for any other form of a substance.

To that end, ECHA has been collaborating closely with major EU and worldwide regulatory authorities to develop enough scientific and regulatory capability.

 

In its second Regulatory Review of Nanomaterials, the European Commission determined that REACH provides the appropriate framework for risk management of nanomaterials when they appear as chemicals or combinations.

Companies that make or import nanoforms must comply with specified legal restrictions under REACH as of January 1, 2020.

These reporting obligations address specific information requirements outlined in revised REACH annexes:

• characterisation of nanoforms or sets of nanoforms covered by registration (Annex VI);

• chemical safety assessment (Annex I);

• registration information requirements (Annexes III and VII-XI); and

• downstream user obligations (Annex XII).

The changes apply to all new and existing nanoform registrations.

Different categories can be assigned to a material based on its size or shape. When reviewing available information for categorization purposes, one must evaluate the forms or physical states in which the chemical or mixture is placed on the market and in which it may reasonably be expected to be utilised.

- A Chemical Safety Assessment (CSA) recorded in a Chemical Safety Report (CSR) is required under Annex I of REACH for production/import volumes of 10 tonnes or more per year. This involves a hazard evaluation, and if the chemical fits the categorization and labelling standards, an exposure assessment, which includes the development of exposure scenarios, and lastly a risk characterization.

- Even if the substance does not fit the above-mentioned criteria, a registrant may choose to build exposure scenarios in order to define and execute how he manages the nanomaterial at his own site and encourage downstream users to control exposures to human health and the environment.

- Nanomaterials' behaviour and impacts are influenced by a variety of factors, including size, number concentration, surface area, charge, and total surface reactivity.

- These features must be considered when assessing risks to human health and the environment. Additional testing or information may be necessary to address the unique dangers related with nanoparticles. Current test criteria may need to be updated in order to detect particular dangers connected with nanomaterials

Special considerations for a set of tests and standards have been stated based on EU legislation for food-related nanotechnology applications (ESFA, 2011).

Another aspect of nanomaterial’s regulation is the economic parameters for using nanotechnology in commercial products. Producing smart composite packaging material with nanoparticles, for example, incurs significant costs. It's difficult to meet regulatory standards because it has a low profit margin.

The EU's labelling obligations for nanomaterials found in food should be mentioned (European Parliament and Council, 2011, 2012). When employed in culinary applications, inorganic nanoparticles require greater consideration due to their possible toxicity. Carbon black, titanium nitrate (TiN), and silicon dioxide nanomaterials are authorised for use in food packaging under EU laws. Silver, aluminium, zinc oxide, and clay nanoparticles, on the other hand, have not been approved.

The European Commission has created strategic action plans and entities for nanoscience and nanotechnology applications (EC, 2010a, b). The possible dangers of nanoparticles employed in industrial products were revealed by EFSA in its "Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain." Furthermore, physicochemical features, surface morphology, chemical content, and potential exposure levels must all be determined in order to assess the danger of such materials (EFSA, 2011a, b).

The necessity for suitable and validated testing procedures and methods for reliable nanomaterial identification and characterisation prompted stakeholders to conduct additional research and evaluation to reduce uncertainties (FAO/ WHO).

The number of nanoparticles that can be used directly in food or integrated into packaging materials is regulated by EU legislation. Migration research data and any health hazards should be reported for packaging applications (EC, 2004, 2007). According to the European Commission (2013), all food additives in the form of engineered nanomaterials must be listed on food labels. The words "nano" in brackets must appear after the names of those substances (FAO/WHO).

The main regulatory framework for cosmetics in the EU is EU Regulation 1223/2009. Based on this structure, a list of all NMs used in cosmetics should be available to all consumers. Most recently (i.e., October 2019), the EU updated the existing guidance on nanomaterials in cosmetics with the Guidelines for the Assessment of Safety of Nanomaterials in Cosmetics by the SCCS (SCCS/1611/19). SCCS provides industry guidance to government agencies to comply with the EC 1223/2009 requirements for the safety assessment of NMs for use as cosmetic ingredients. In accordance with the 2012 guidelines SCCS/1484/12, a complete ban on animal testing under the Cosmetics Regulation came into effect from March 2013, and alternative methods have been used to evaluate the safety of cosmetic ingredients (including NM testing) since then.

In Europe, safety evaluation is mandatory for all cosmetic ingredients. The same goes for nanomaterials used in cosmetics. By the end of 2018, less than 1.5% of cosmetics listed in the CPNP were declared to contain nanomaterials. According to Regulation (EC) No 1223/2009, cosmetic products must indicate whether they contain NM. Even if the NM used is not described in the regulations (which includes most nanoscale dyes, UV filters and preservatives), special procedures must be followed. In case of doubt, the European Commission may request further investigation by the SCCS. The European Commission must approve the use of nano-ingredients in cosmetics. In terms of labelling, all NMs must be listed on the cosmetic label, starting with the name of the chemical followed by the word (nano) in parentheses. The latest updated Cosmetics NM Catalog states that the catalog is "for informational purposes only and is not an expressly permitted list of nanomaterials". So far, the EU has permitted the use of NMs as UV filters containing (nano) TiO2, ZnO, MBBT and trisbiphenyltriazine. Carbon black (nano) can also be used as a colorant in cosmetics. The EU published a catalog of all NMs used in cosmetics in the EU in 2017 and was last updated in December 2019.

In May 2012, the Regulation on the marketing and use of biocidal products was enacted. The European Chemicals Agency oversees the biocidal product authorization procedure. The definition of the word "nanomaterial" provided by the European Commission has been integrated into the text (Article 3, 1z). Nonetheless, the Commission will have the authority to change the meaning of the word considering technological and scientific advancements (Article 3, 5).

The law prohibits the use of the most hazardous compounds and recognises the dangers that nanomaterials may bring. The language defines how active compounds can be approved and specifies that active substance approval does not apply to nanomaterials unless they are specifically acknowledged (Article 4).

In order to react to the special features of nanomaterials, Annex II mandates that the scientific suitability of standard test techniques, or their adaptation to nanomaterials, be explained. The requirements for receiving an authorization are outlined in Article 19. When nanoparticles are employed in biocidal products, the environmental, human, and animal health risks must be addressed independently.

There is no streamlined authorization procedure for biocidal products using nanomaterials, according to Article 25. When test techniques are used to nanoparticles, a description of their scientific suitability for nanomaterials, as well as the technological modifications or alterations performed to respond to the unique properties of these materials, must be supplied (Annex III). The regulatory language also includes rules for labelling treated items before they are placed on the market. The names of all nanomaterials found in biocidal products must be included, followed by the term "nano" in brackets, according to the guidelines (Article 58, 3d).

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Persistent Organic Pollutants (POPs), also referred to as “emerging contaminants”, include a range of chemical substances from diverse applications, ranging from medicines, personal care, household cleaning products, lawn care, agricultural products, among others.

The toxicity of POPs has been long investigated, and researchers found that these chemicals may have long-range mobility and long-lasting duration, leading to environmental contamination and pollution. POPs are often classified as Substance of Very High Concern (SVHC) with hormone disruption consequences, bioaccumulation and biomagnification through the food chain. The presence of POPs in the environment and in human health can lead to several complications, from mild effects to more serious consequences, for example, reproductive disruptions and immunological disorders.

Since POPs are not easily broken down, a characteristic that guarantees its continuation in the environment, the contaminant consequences are still being investigated. In other words, the emerging contaminants are mainly not from new pollutants that recently entered the environment. Instead, there is a good understanding of contaminants, but the consequences to their exposure are still being discovered.

Countries have created a set of rules and regulations to regulate, control, and mitigate POPs use and its effects on the environment and on human health. The essence of these legislations is to eliminate the production, trading, and use of such chemicals, including storage and waste management.

International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parties to reduce their emissions below 1990 levels.

The Stockholm Convention is an international conference specifically for POPs proposed in May 2001 in Sweden (complementing the Aarhus Protocol), entering into force in 2004. Among the objectives, the Stockholm Convention aims to:

  • Prohibit, eliminate, and restrict several POPs in the production, use, import, and export.
  • Ensure that waste containing POPs is managed safely and in an environmentally sound manner.
  • Promote tools for information exchange, public access, awareness and education, research, development and monitoring, reporting, and implementation of plans to fight POPs pollution.

The Stockholm Convention is considered the main international instrument to address POPs. Most countries adhere to the Stockholm Convention.

The EU is a party to the United Nations Economic Commission for Europe (UNECE) Air Convention (renamed in 2020; previously the UNECE Convention on Long-Range Transboundary Air Pollution (CLRTAP)). The Air Convention’s 1998 Aarhus Protocol on Persistent Organic Pollutants obliges parties to reduce emissions of certain POPs and has banned or restricted the use of some compounds.

In 2001, the Stockholm Convention was adopted, building on the Aarhus Protocol to act on POPs at the international level. These pieces of legislation are implemented in the European Union by the POPs Regulation (Regulation EU 2019/1021 of the European Parliament and of the Council concerning Persistent Organic Pollutants - POPs).

The POPs Regulation reflects the international framework proposed by Aarhus Protocol and by the Stockholm Convention in the European Union. The main objective is to protect human health and the environment with specific control measures that:

  • prohibit or severely restrict the production, placing on the market and use of POPs
  • minimize the environmental release of POPs that are formed as industrial by-products
  • make sure that stockpiles of restricted POPs are safely managed; and
  • Ensure the environmentally sound disposal of waste consisting of or contaminated by POPs.

The European Chemical Agency (ECHA) makes available a database to list substances subject to the POPs Regulation. The list can be accessed here.

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The European Medical Devices Regulation (MDR) replaced the previous Medical Device Directive (MEDDEV), which was lagging the current state of the art. The MDR will be: 

  1. Introduced progressively 

  1. Updated regularly by means of Implementing Acts. 

  1. The existing MEDDEV Guidance Documents have been implemented into the text of Regulation. 

  1. Final version of the European Medical Device and IVD Regulations published on 5 May 2017 

  1. Europe Medical Device Regulation (MDR) 

  1. Europe In Vitro Diagnostic Regulation (IVDR) 

  1. MDD 93/42/EEC 

CONSOLIDATED Medical Device Directive (93/42/EEC) 

In-Vitro Diagnostic Devices Directive (98/79/EC)- Directive 98/79/EC on In Vitro Diagnostic Medical Devices 

The regulation of medical devices is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and avoiding access to products that are unsafe. WHO has a mandate, as outlined in the World Health Assembly (WHA) Resolution 60.29 “to encourage member states to draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, safety and efficacy of medical devices and, where appropriate, to participate in international harmonization. The 67th WHA(World Health Assembly) approved the resolution “Regulatory system strengthening for medical products”. It states the importance of regulations for medical devices as one of the medical products, for better public health outcome and to increase access to safe, effective and quality medical products. New Medical Device Regulations have been introduced after the Covid-19 Pandemic and the IVDR will be fully applicable on 26 May 2022, after a five-year transition period. The MDR and IVDR represent a significant development and strengthening of existing regulatory system for medical devices in Europe and will replace the original Directives which have been in place for over 25 years. 

 

A notified body is an organization designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. The European Commission has published a list of such notified bodies. Manufacturers outside the EU must identify an EU-based authorized representative unless they have a registered business within the European Union. The primary task of the authorized representative is to be point of contact for the national health authorities of the Member States. Authorized representatives or manufacturers typically also register devices in individual member states. In the future, registration will become easier. With the Commission’s 2010 Decision to enforce use of Eudamed—the EU-wide database for devices on the market—registration of in vitro diagnostics in each country became redundant. 

Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device. 

Stage 1: Device Classification 

Medical devices are usually divided into subgroups. 

In Europe medical devices are divided into three different groups:  

  • Active implantable medical devices(AIMD), 

  • General medical devices and 

  • In vitro diagnostic devices (IVD).

Stage 2: Notification Procedure 

  • Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 39 was completed and which comply with Annex VII. 

Stage 3: CE Marking 

Known as the “new approach” directives, these directives outline a set of “essential requirements,” rely on use of voluntary EU-wide harmonized standards and offer a choice of conformity assessment modules.

Presence of certain substances shall be labeled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. Appropriate precautionary measures shall be given in the instructions for use (If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups). 

Serial No. 

Fee Type 

Amount/Pricing 

01. 

Marketing-authorisation application (single strength, one pharmaceutical form, one presentation) 

From €296,500 

02. 

Extension of marketing authorisation (level I) 

€89,000 

03. 

Type-II variation (major variation

€89,000 

04. 

Scientific Advice 

From €44,400-€89,000 

05. 

Annual fee (level I) 

€106,300 

06. 

Establishment of MRLs 

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post-submission support and technical liaison with authorities. 

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In the European Union, the European Green Deal aims at establishing a new sustainable, low-carbon, resource-efficient and competitive economic model. 

 

Several strategies and action plans apply the overarching vision of the European Green Deal to specific economic sectors. Each of these strategies and action plans detail the legislative changes that will be proposed (either through new regulations or amendments to existing ones). 

 

Additionally, some regulatory initiatives from before the European Green Deal also brought circularity goals into the regulatory framework of the EU, such as the database for Substances in Concern in Products (SCIP).