- butylparaben
- propylparaben
- methylisothiazolinone and methylchloroisothiazolinone
Read more about it here: http://www.ceway.eu/eu-retricted-banned-use-certain-preservatives-cosmetics/
EU decided to restrict the use of the following ingredients:
- butylparaben - propylparaben - methylisothiazolinone and methylchloroisothiazolinone Read more about it here: http://www.ceway.eu/eu-retricted-banned-use-certain-preservatives-cosmetics/
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Each cosmetic product should contain microbiological specifications of the finished product as well as challenge test in the PIF.
Certain cosmetic products may not require those specifications though. Examples of such products are products with a high alcohol content (>20%), products based on organic solvents and products with a high (above 10) or low (below 3) pH. A scientific justification for the lack of microbiological specifications has to be provided, however. REACH is covered in the Regulation (EC) No 1907/2006, which was published in December 2006 and entered into force in June 2007. REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals. REACH streamlines and improves the former legislative framework on chemicals in the EU. REACH aims to ensure: · A high level of protection for human health and the environment · The promotion of alternative methods for assessment of hazards of substances · Free circulation of substances on the internal EU market · Enhancing competitiveness and innovation REACH is based on the idea that industry itself is best placed to ensure that the chemicals it manufactures and puts on the market in the EU do not adversely affect human health or the environment. SCOPE REACH divides the substances into 2 categories: · Non-phase-in substances (those not produced or marketed prior to the entry into force of REACH) · Phase-in substances (those substances listed in EINECS, or those that have been manufactured in the EU, but not placed on the EU market, in the last 15 years or the so called “no longer polymers” of Directive 67/548) REACH is covering all substances, whether manufactured, imported, used as intermediates or placed on the market, either on their own, in preparations (such as cosmetics) or in articles, unless they are radioactive, subject to customs supervision, or are non-isolated intermediates. Waste is specifically exempted. REGISTRATION REQUIREMENTS Manufacturers or importers of substances in quantities exceeding 1 tonne of the substance per year must comply with REACH, and must submit a registration to the European Chemicals Agency. Certain substances, however, don’t require registration: · Substances that are adequately regulated under other legislations (such as medicinal products or low risk substances) · Substances occurring in nature (like minerals, ores, ore concentrates) if they are not chemically modified · Polymers (in certain circumstances monomers in polymers have to be registered) · The exemptions are listed in Annexes IV and V of the REACH Regulation For the substances on their own or in preparations, manufacturers or importers have to submit the following registration documents to the Agency: · A technical dossier for substances in quantities of 1 tonne or more · A chemical safety report for substances in quantities of 10 tonnes or more A registration means that the manufacturer or importer has provided a registration dossier to the European Chemicals Agency and not receive any indication that the dossier is incomplete. This, however, does not by itself mean approval. To find out the properties of the substances, information requirements are set out in the testing annexes that vary according to the tonnage in which the substance is manufactured or imported, and to the needs of the chemical safety assessment. The tonnage ‘trigger’ has been chosen as it gives an indication of the potential for exposure. Tonnage for phase-in-substances is calculated as a three year average as long as they have been manufactured or imported for 3 consecutive years. The information that has to be submitted: · Substances in quantities of 1 to 10 tonnes: o Substances meeting at least one of the two criteria set out in Annex III: a defined set of information from Annex VII along with any other available information has to be submitted o Other substances: physicochemical information and any available and relevant (eco)toxicological information · Substances in quantities of 10 to 100 tonnes: o Information from the application of the relevant testing Annexes VII and VIII needs to be submitted as well as all other available and relevant information · Substances in quantities of 100 tonnes or more: o Information from the application of Annexes VII and VIII needs to be submitted as well as all other available and relevant information o If the manufacturer or the importer does not possess the required information from Annex IX, and for the substances at or above 1000 tonnes, Annex X, proposals for testing for the purpose of registration need to be submitted The chemical safety report (CSR) for substances manufactured or imported in quantities starting at 10 tonnes, documents the hazards and classification of a substance and the assessment as to whether the substance is PBT or vPvB. The CSR also describes exposure scenarios for specific uses of substances that are classified as dangerous or are PBT or vPvB substances. For phase-in substances, more registration deadlines are established for their different tonnage ranges. Additionally, some high concern substances need to be registered early. See the deadlines below: For the registration of substances in articles (an object which during production is given a special shape, surface, or design which determines its function to a greater degree than does its chemical composition), a special regime applies:
· All substances which are intended to be released from articles should be registered according to the normal rules, including tonnage deadlines and information requirements, when present in the articles in quantities of 1 tonne or above · All substances of very high concern present in articles above a concentration limit of 0.1 % weight by weight and present above 1 tonne per year must be notified to the European Chemicals Agency except where exposure to humans and environment can be excluded during normal conditions of use including disposal. In such case safety instructions should be provided. Information will also be made available to consumers on request. COMMUNICATION REQUIREMENTS The communication requirements of REACH ensure that not only manufacturers and importers but also their customers, i.e. downstream users and distributors, have the information they need to use chemicals safely. Information relating to health, safety and environmental properties, risks and risk management measures is required to be passed both down and up the supply chain. AUTHORIZATION AND RESTRICTIONS Substances of very high concern require an authorization for their use and their placing on the market. The following substances require authorization: · CMR category 1 and 2 · PRT, vPvBs · Identified from scientific evidence as causing probable serious effects to humans or the environment equivalent to those above on a case-by-case basis, such as endocrine disrupters. REACH Regulation also deals with the restrictions of substances which pose an unacceptable risk to health or the environment. All activities with a substance which are not restricted are allowed under REACH unless the substance is included in the authorization system. CLASSIFICATION AND LABELLING REACH is promoting an agreement on the hazard classification (and consequently labelling) of all dangerous substances either manufactured in the EU, or imported into the EU. Cosmetics Good Manufacturing Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics. This Regulation sets very high requirements to ensure consumers’ safety, and is concerning all the participants in the cosmetics products chain, European and non-European. Amongst these new legal requirements, all cosmetics products circulating in the European Market will have to be produced according to the Cosmetics Good Manufacturing Practices described by the ISO 22716 standard.
Compliance with this standard can be shown either by the ISO 22716 certificate, or by a declaration stating that the products are produced according to ISO 22716. ISO 22716 is an international standard that gives guidance for the production, control, storage and shipment of cosmetic products. It deals with all aspects of the supply chain of cosmetic products. The guidelines cover the quality and safety of the product, and they affect manufacturers, as well as suppliers, retailers, brand holders and retailers of cosmetic products. It does not, however, cover safety aspects for the personnel engaged in the plant, or the protection of the environment. Animal testing is a big subject of discussion both among the consumers and among cosmetics manufacturers. As you may know, animal testing has been banned in the EU. Let’s see some more details about this.
The ban on animal testing has already been announced in the 7th Amendment of the Cosmetics Directive 76/768/EEC. Animal tests have been prohibited on finished cosmetic products and on cosmetic ingredients (testing ban). Furthermore, the sales of finished cosmetic products and ingredients included in cosmetic products, which were tested on animals, have been prohibited (marketing ban). The prohibition is also extended to all beauty and hygiene products tested on animals outside the EU, which may not be sold inside the EU. Application dates for the ban of animal testing are as following:
1. Introduction
The aim of this explanatory note is to provide guidance with respect to the scope of application of Regulation 1223/2009/EC of the European Parliament and of the Council of 30 November 2009 on cosmetic products[1] (hereafter "Cosmetics Regulation"), i.e. the application of the legal requirements set out in that Regulation to cosmetics placed on the Union[2] market via websites established in a non-EU Member State. While the matter was discussed in the context of the adoption of the Cosmetics Regulation, no express provisions in the Cosmetics Regulation address the issue. As a result, a Commission Declaration attached to the Cosmetics Regulation stated that "The Commission commits to clarifying the situation regarding Internet sales of cosmetic products prior to the date of application of the Regulation". As demonstrated further in the note, a legal analysis of the letter and the purpose of the Regulation leads to the conclusion that the selling of cosmetic products to EU consumers from websites established outside the EU falls in the scope of the Cosmetics Regulation. It should be noted that this guidance does not address:
Article 1 of the Cosmetics Regulation provides that: "This Regulation establishes rules to be complied with by any cosmetic product made available on the EU market, in order to ensure the functioning of the internal market and a high level of protection of human health." Therefore, the Cosmetics Regulation pursues three main objectives. First, its main goal is to ensure that EU consumers have access to safe cosmetic products on the European market. Requiring cosmetic products sold over the Internet to European consumers from websites established in a third country to comply with the requirements of the Regulation is in line with this aim. Second, the Regulation aims to ensure the smooth functioning of the internal market. Were the Cosmetics Regulation not to apply to products sold over the Internet by companies established outside the EU, this would lead to disruptions in the internal market. Indeed, Member States would develop different types of regulatory requirements and specific national controls of compliance with the legal obligations. Third, the aim is also to guarantee that companies complying with the legal requirements of the Cosmetics Regulation do not suffer unfair competition from outside the EU. This is why the Cosmetics Regulation applies to companies established outside the EU selling cosmetics products in the EU. Allowing companies established outside the EU to target directly EU consumers via the Internet with products which do not satisfy the requirements established in the Cosmetics Regulation, could pose a serious risk of unfair competition. These companies would be able to sell cosmetics at a cheaper price because they do not have to fulfil the legal obligations imposed by the Cosmetics Regulation. 3. Is a cosmetic product sold to European consumers from a website established outside the EU placed on the EU market? According to Article 2(1)( h) of the Cosmetics Regulation "placing on the market" is defined as "the first making available of a cosmetic product on the Community market".
Based on an analysis of the elements of the definition of "making available on the market", it appears that a website established outside the EU which targets directly European consumers fulfils all of them. "Any supply of a cosmetic product for distribution, consumption or use (…)" This notion covers all types of transfers of a cosmetic product with the intention of distribution, consumption or use on the Community market. An Internet sale aims to provide cosmetics to European consumers. Therefore, this is a supply for consumption. "(…) on the Community market (…)" If the website targets European consumers (e.g. possibility to ship to the European Union, to order from the European Union, currency, language, etc.), it can be considered that it aims directly at the Union market because European consumers can order and receive the proposed product. "(…) in the course of a commercial activity (…)" The European consumer buys the cosmetic product over the Internet. In the definition, there is no mention of a commercial activity within the EU territory. "(…) whether in return for payment or free of charge." The product is considered to be supplied either when the physical hand-over or the transfer of ownership has taken place. This transfer can be for payment or free of charge, and it can be based on any type of legal instrument. Thus, a transfer of a product is considered to have taken place, for instance, in the case of sale, loan, hire, leasing and gift.
According to the Guide to the implementation of directives based on the New Approach and the Global Approach ("Blue Guide")[4] the concept of placing on the market refers to each individual product, not to a type of product, and irrespective of whether it was manufactured as an individual unit or in series. Therefore, in the case of sales over the Internet, it would concern every product sold through the website. It can be argued that, in the case of websites established outside the EU targeting directly EU consumers, these cosmetics are only "potentially" placed on the market because they are not placed on the market until a European consumer orders them. Given this specificity, it can be considered that the website has to comply with the legal requirements of the Cosmetics Regulation regarding the product as soon as the product is directed to European consumers (e.g. labelling), and that the other obligations (e.g. responsible person, notification) have to be fulfilled at the latest when the company selling its products over the Internet receives an order from a European consumer. In conclusion, it can be considered that cosmetics sold over the Internet are placed on the Union market. 4. Legal consequences In the Cosmetics Regulation, every actor has specific legal obligations. The basic rule requires that there be, within the Union, a person responsible for a cosmetic product sold in the EU market. Indeed, the responsible person within the Union has to comply with the legal obligations stemming from the Cosmetics Regulation (e.g. notification, labelling, safety issues). This legal requirement is established in Article 4, more specifically, in paragraphs 1 and 2: 1. Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. 2. For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation. For all the products placed on the market, there must be a responsible person. The reason for this requirement is to ensure that somebody is in charge of all the legal obligations stemming from the Cosmetics Regulation. Where a website established outside the EU and targeting directly EU consumers sells cosmetics to an EU consumer, there is a direct Internet sale to this consumer. There is no intermediary, because there is no importer in the meaning of the Cosmetics Regulation. The consumer is the first person receiving a given cosmetic product in the EU. However, a consumer cannot be considered as the responsible person for this product. If the holders of websites established outside the EU and targeting directly EU consumers were not required to comply with the Cosmetics Regulation, this would mean there is no responsible person for that product. Therefore, the conclusion of this analysis is that companies selling cosmetic products through Internet websites established outside the EU and directly targeting EU consumers need: - to appoint a responsible person in the European Union; - to follow the legal requirements of the Cosmetics Regulation. [1] OJ L 342, 22.12.2009, p. 59–209. [2] References to the Union in this Regulation shall be understood as including any other country with which the Union has concluded an agreement which confers on that country the same status as a Member State for the purpose of application of this Regulation. [3] Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce') OJ L 178, 17.7.2000, p. 1–16; Article 2 point (c) "established service provider": a service provider who effectively pursues an economic activity using a fixed establishment for an indefinite period. The presence and use of the technical means and technologies required to provide the service do not, in themselves, constitute an establishment of the provider". [4] Published by the European Commission (1999), see http://ec.europa.eu/enterprise/policies/singlemarket- goods/files/blue-guide/guidepublic_en.pdf , in particular page 19. The Responsible Person for cosmetic products placed on the EU market has to keep a Product Information File (PIF) for each of these cosmetic products. A complete Product Information File is a basis for the Responsible Person to be able to perform the “Notification”. The requirements for the PIF are described in Article 11 and Annex I of the EU Cosmetics Regulation 1223/2009/EC, while there are some additional requirements described in the other articles as well. Responsible Person has to keep the PIF readily accessible in electronic or other format at his address, which is indicated on the product label, for the competent authority of the Member State in which the File is kept. The PIF has to be kept at one single address within the Community by the Responsible Person, and has to be kept updated at all times. The information contained in the PIF shall be made available in a language which can be easily understood by the competent authority of the Member State, and the File has to be kept for a period of ten years following the date on which the last batch of the product was placed on the market. Furthermore, where the cosmetic product presents a risk to human health, the Responsible Person 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 File is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures to be taken.
When conducting the notification to CPNP, the Responsible person needs to upload the product formula as well.
The formula can be uploaded either in exact concentrations, in concentration ranges or as a predefined frame formulation. ‘Frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. New frame formulations are now available. They will be integrated in the CPNP system as from January 2014. Once the Frame Formulations 2013 will be in the system, the Frame Formulations 2011 will not be available any more for new notifications. Please note that old notifications for which Frame Formulations 2011 were used remain valid. You can find Frame Formulations 2013 here: https://webgate.ec.europa.eu/cpnp/resources/ff/FF-2013-EN-TRA-00.pdf When trying to enter the EU market, different languages might not be the first thing that comes to your mind. You might also be wondering why we listed the languages in which different safety assessors can issue cosmetic safety assessments in our list. Let us tell you why.
Most companies, especially outside the EU, don't realize that there are 25 different official languages in the 27 EU member states. Virtually every EU member state has its own official language, while some of them (like Belgium, Luxembourg etc.) have even more than one official language. Why is this important? Well, first of all, as a manufacturer of cosmetic products, you would probably be more successful in selling your products in different EU countries if the information about the product would be available in a language which the local consumers understand. However, not only better sales results, also the legislation obliges cosmetic manufacturers to display certain information about the product on product labels in the official language(s) of the country(ies) in which they sell their products. Secondly, the Product information file (PIF) (read more about it in our next blog), which contains also a product safety assessment, has to be kept by the Responsible person in one of the EU member states in a language easily understood by the local competent authority. If your Responsible person is based in a country where English is an official language (UK & Ireland), the PIF (and safety assessment, as a part of PIF) can therefore be in English. Also certain other countries permit PIF to be in English besides the local official language(s), while some others don't. To find out which are the official languages in different EU countries contact our official partner CE.way Regulatory Consultants Ltd www.ceway.eu IFRA STANDARDS
In order to perform the safety assessment of your cosmetic product, companies need to have also physical/chemical specifications of the raw materials included in the finished product. If the product contains fragrances (perfumes), then you will also need to show IFRA compliance for these fragrances. What is IFRA and what are IFRA standards? IFRA is an International Fragrance Association, which was founded in Geneva in 1973. IFRA aims to represent the collective interests of the fragrance industry, and its main purpose is to promote the safe enjoyment of fragrances worldwide. RIFM (industry’s scientific centre) together with IFRA makes sure that the establishment of usage standards for fragrance materials is put into practice according to the available scientific recommendations and that member companies comply with those standards. IFRA standards form the basis for the globally accepted and recognized risk management system for the safe use of fragrance ingredients and are part of the product risk management process, the IFRA Code of Practice. This is the self-regulating system of the industry, based on risk assessments carried out by an independent expert panel (REXPAN)[1]. IFRA standards are required in the EU as part of the physical/chemical specifications and consequently the safety assessment, the Brazilian policy makers have adopted IFRA standards into law, while also ASEAN (Association of Southeast Asian Nations) cosmetic directive refers to the IFRA standards as far as fragrances in cosmetic products are concerned. [1] Source: IFRA website: http://www.ifraorg.org/en-us/home/public_home/ |
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