Government assignment Faster adaptation of the regulations for cosmetic products. Report from the Medical Products Agency

Transcription

1 Government assignment Faster adaptation of the regulations for cosmetic products Report from the Medical Products Agency Ref. no Date: January 2017

2 When quoting Medical Products Agency reports, please remember to indicate the source: The report s name, year and Medical Products Agency. Medical Products Agency, January 2017 Reference number: Postal address: Box 26, Uppsala Visiting address: Dag Hammarskjölds väg 42, Uppsala Telephone: +46(0)

3 Table of contents 1. The assignment Interpretation of the assignment Delimitation Consultation Background History and origin of substance lists for cosmetic products Ongoing changes in the regulation of substances The process for updating substance rules in the Cosmetics Regulation Legal regulation of the process for the change procedure Investigation of the need for further restrictions of substances Focus on the colourants list (Annex IV) Colourants that should be prioritised for further review Changes to the regulation for permitted colourants The hair dye strategy Double regulation within the Cosmetics Regulation Regulation of colourants in foods and pharmaceuticals Published scientific information concerning health effects Use of colourants Presence of colourants in random samples Colourants classified according to the CLP Regulation Azo dyes Overall assessment of colourants Investigation of faster adaptation of new findings and hazards Use of positive lists Improvement proposals regarding the presence of substances on the lists Improvement proposals for maintaining the relevancy of the substance lists Improvement proposals linked to the process Conclusions Definitions and abbreviations References...32 Annex 1. Inventory of time expenditure for the regulation of substances...35 Annex 2. Table with the Medical Products Agency s criteria for prioritising which colourants in Annex IV need to be reviewed...37 Annex 3. Calculation of Margin of Safety

4 1. The assignment This is a government assignment described in appropriation directions S2015/08135/RS of 17 December : In consultation with the Swedish Chemicals Agency, the Medical Products Agency shall produce proposals for how, in the context of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, detailed provisions for individual substances can be adapted sufficiently quickly to new findings on hazards and risks. The assignment includes considering and developing proposals for further restrictions of hazardous substances within the scope of the Regulation, such as colourants, preservatives and UV-filters. The assignment is to be reported to the Government Offices (Ministry of Health and Social Affairs) no later than 31 January Interpretation of the assignment The Medical Products Agency has interpreted hazards and risks mentioned in the assignment above as hazards and health risks. The reasons for this are that restrictions are requested within the scope of the Cosmetics Regulation, which encompasses health risks, but not environmental risks, and that the assignment has been issued to the Medical Products Agency, i.e. the authority that has supervisory responsibility for health risks. This interpretation was discussed with representatives of the Swedish Chemicals Agency and checked with the Ministry of Health and Social Affairs in June Delimitation There are over 6,000 substances that are used in cosmetic products. The Medical Products Agency is unable to produce documentation for all these substances regarding their possible health effects, for which reason the assignment was delimited to those substances listed in Annexes III, IV, V and VI of the Cosmetics Regulation. Based on the substance groups in these annexes, a further selection was made, resulting in a focus on the colourants in Annex IV. The reasons for this selection are given in section Consultation In accordance with the assignment, there has been consultation with the Swedish Chemicals Agency. This primarily took place in the form of two joint project meetings, but also through regular coordination. At the same time as this assignment, the Swedish Chemicals Agency has had a government assignment concerning a number of preservatives in cosmetic products. Since there are many parallels between these projects, the agencies have cooperated in order to raise issues between the projects. Issues regarding colourants have been discussed with the National Food Agency. The government assignment has also been discussed at meetings with representatives of the cosmetics industry in February and November

5 2. Background In the early 1970s, work began to produce a common legislation for cosmetic products within the EU. The aim was to avoid trade barriers and to ensure better protection for consumers using cosmetic products on a daily basis. In 1976, Directive 76/768/EEC 1 on cosmetic products (the Cosmetics Directive) entered into force, and about 30 years later this Directive was recast into a Regulation, with the addition of several provisions. Since 2013, the regulations have been contained in Regulation (EC) 1223/2009 on cosmetic products 2. The entry into force of the Cosmetics Regulation increased demands on companies manufacturing and importing cosmetic products to the EU and increased reporting requirements on regulators within the EU. However, the aim of the regulations remained the same: to ensure a high level of protection for human health and to facilitate the movement of cosmetic products on the EU market. The Cosmetics Regulation also contains a safeguard clause (Article 27) that allows a competent authority to withdraw or recall cosmetic products which, although they meet the requirements of the Cosmetics Regulation, have been deemed to constitute a serious risk to human health. The environmental properties of ingredients in cosmetic products are regulated in Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 3 as the Cosmetics Regulation only covers health requirements. The responsibility for controlling that cosmetic products in Sweden adhere to the rules of the Cosmetics Regulation is shared by the Medical Products Agency and Sweden s municipalities. 4 The Medical Products Agency is represented in the EU s work to regulate certain substances in the Cosmetics Regulation. For example, this has recently occurred in the case of diethylene glycol monoethyl ether (DEGEE), methylisothiazolinone and 3-benzylidene camphor. Before a cosmetic product is placed on the EU market, the responsible company shall have produced a safety report showing that the product, under normal or reasonably foreseeable use, is safe for human health. Examples of further requirements under the Cosmetics Regulation are that the products shall be notified to a central register (CPNP 5 ) maintained by the Commission, be properly labelled, comply with good manufacturing practice (GMP) and follow the substance regulations contained in the Regulation. Most substances in cosmetic products have no specific rules, but some substances are prohibited or may only be included if certain restrictions are observed. These substances are listed in Annex II and in Annex III to the Cosmetics Regulation. The Regulation also regulates which substances are permitted to use for certain functions. No substances other than those listed in Annexes IV VI in cosmetic products may be used as colourants (Annex IV), preservatives (Annex V) and UV-filters (Annex VI). For hair dyes, however, colourants other than those listed in Annex IV may be used. Substances regulated in Annexes III VI may be included in cosmetic products provided that the set restrictions and conditions are met. Restrictions might, for example, be a maximum permitted level, a limited area of use or product type. An example of conditions is that the product shall have a particular warning in its package labelling. The development of the Cosmetics Regulation in retained lists of regulated substances from the previous Directive of The Commission has not implemented any overarching revision of all the substances in the annexes since the 1980s, although individual substances have been reviewed. The need for regular and systematic review of the substance rules in the Cosmetics Regulation was already stated in the report of the All Party Committee on Environmental Objectives, SOU 2012:38 6 but, as yet, no revision is planned for assessing whether there remain grounds for considering these substances not to affect human health. The consequence of there not having been any review is that the substances in Annexes IV VI are being used even though it might be the case that there are new health findings to demonstrate that they should be used with 5

6 caution or even restricted. Another aspect is that the substances might be restricted or prohibited in other legislation, such as for foods, chemicals or pharmaceuticals, but still continue to be permitted in cosmetic products, without new findings having been taken into consideration in the assessment of cosmetic products. Companies and government agencies lack incentives to supplement existing information for substance regulation in the Cosmetics Regulation. A reason why few scientific studies are conducted that support safe use in cosmetic products is that animal testing has not been permitted since March 2013 and that there are no alternative tests for evaluating certain intrinsic properties of the substances. Nevertheless, the lists have seen some expansion over time as companies have proposed the addition of substances. Some individual substances have also been removed as a result of a Member State pointing out the health risks, but this has taken time and required major efforts. The advantages of the lists are that they clearly state which substances are permitted or have restrictions, something that makes matters easier for consumers, companies and regulators. The lists also contribute to a harmonised view, which makes it easier for companies to conduct free trade in cosmetic products. Several of the substances listed in the Cosmetics Regulation are under double regulation, i.e. appear in several of the annexes. This is primarily the case for colourants and is a result of the EU s hair dye strategy, which has led to hair dyes more recently being evaluated and regulated in a separate project. For example, 37 substances in Annex IV are stated to be permitted as colourants in cosmetic products at the same time as Annex II states that they are prohibited from being used as hair dyes. These rules are perceived to be contradictory and difficult to explain to consumers and companies. Substances used in cosmetic products are also used in other product groups, such as foods, pharmaceuticals, chemical products and medical devices. Preservatives are an example of a substance group that occurs in several adjacent product areas. However, the regulation of these substances differs depending on legislation. For chemical substances and mixtures in products placed on the market within the EU, Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (the CLP Regulation) 7 applies. In accordance with this Regulation, a hazard classification of these substances is made. However, this hazard classification of a substance is not transferred automatically to the cosmetics regulations. This means that a substance can, for example, be classified as sensitising under the CLP Regulation without this information having been included in the assessment by the SCCS and listed in the annexes to the Cosmetics Regulation. However, the substances that receive a harmonised classification as carcinogenic, mutagenic or toxic for reproduction (CMR) in the CLP Regulation are covered by Article 15 of the Cosmetics Regulation. This means that the use of such substances in cosmetic products is regulated. Investigation of the health and environmental impact of cosmetic products is part of the work on the Action Plan for a Non-toxic everyday environment 8 within the environmental quality objective A Non-Toxic Environment 9. This has a special focus on the exposure of children and young people to chemical substances. Although cosmetic products are used by the entire population, the group of children and young people is of particular interest since they might be more sensitive to chemicals but also in many cases major users of cosmetic products. The Medical Products Agency has previously analysed the presence of both fragrances 10 and preservatives 11 in cosmetic products, and has controlled tattoo inks 12 and sunscreen products 13. In these controls, the Medical Products Agency has identified deficiencies; in some cases non-permitted substances are used, which indicates the need for continued supervision. The Medical Products 6

7 Agency s ongoing work with substances regulated under the Cosmetics Regulation contributes to the objective A Non-Toxic Environment. Parallel to this government assignment, the Swedish Chemicals Agency is conducting an assignment to evaluate substances such as triclosan and 13 other chlorinated preservatives in cosmetic products. 14 This work assesses the health and environmental aspects of these substances that are found in Annex V to the Cosmetics Regulation. The Swedish Chemicals Agency s government assignment is a part of the action plan to implement the strategy of a Non-toxic everyday environment and to achieve the environmental quality objective A Non-Toxic Environment. 11 The Medical Products Agency is collaborating with the Swedish Chemicals Agency in this assignment that will be completed in spring History and origin of substance lists for cosmetic products When the rules were developed in the 1970s, there was discussion of how substances in cosmetic products would best be regulated; by means of negative lists (that prohibit substances) or positive lists (that permit substances). The argument that more information and data is needed in order to allow a substance likely contributed to the Commission s decision to introduce a longer, more general list of prohibited substances in cosmetic products and a shorter positive list where the documentation was deemed adequate. The Commission also drafted a provisional positive list of substances that were temporarily permitted but that were to be evaluated within a three-year period. The idea was that it would be possible to introduce more positive lists for uses where regulations were deemed necessary for increasing consumer protection. The Commission s thinking in 1975 was that these positive lists would initially cover the functions antioxidants, colourants, hair dyes, preservatives and UV-filters. 15 When the rules were developed, the European Parliament endorsed the inclusion of a ban list in the Cosmetics Directive and the producing of positive lists in the long term. 16 The European Economic and Social Committee also commented on the substance regulation in the proposed Cosmetics Directive. The Committee supported the introduction of a negative list but stressed that this should be expanded in the long term. Positive lists were viewed as useful in those areas that were the most urgent on the grounds of health. Lists of this kind had worked well in the area of food for colourants and other additives. 17 The development of rules concerning cosmetic products continued for a few more years before the Cosmetics Directive (76/768/EEC) entered into force on 27 July and was incorporated into Swedish legislation when Sweden joined the EU. In 2009, the Cosmetics Directive became the Cosmetics Regulation 4. The Cosmetics Regulation became applicable in July 2013, when it was also given its current structure. This means that substances not permitted in cosmetic products are listed in Annex II, substances with restrictions are listed in Annex III, permitted colourants are listed in Annex IV, permitted preservatives are listed in Annex V and permitted UV-filters are listed in Annex VI Ongoing changes in the regulation of substances In recent years, a number of major issues have been discussed regarding the EU s regulation of substances in cosmetic products. Besides the Commission s hair dye strategy, fragrances have been evaluated. The reason for this was the sensitising 7

8 properties of fragrances. 18 The evaluation of fragrances has resulted in a proposal to expand existing rules for fragrances, such as the declaration of several fragrances in lists of contents, and a proposal to restrict a few substances. The use of substances classified as CMR in cosmetic products is prohibited under Article 15(1) and 15(2) of the Cosmetics Regulation. There is a possibility for derogations if such substances have been evaluated and their use considered safe in cosmetic products. The interpretation of Article 15 is currently being discussed at the EU level. The endocrine-disrupting properties of substances are not regulated in the Cosmetics Regulation as EU-wide criteria for how such substances are to be identified have not yet been adopted. However, Article 15(4) of the Cosmetics Regulation establishes that the Commission shall review this Regulation with regard to substances with endocrinedisrupting properties when Community criteria for identifying substances are available. Discussions about common criteria have been in progress for several years and appear to be nearing a solution. Once this has been agreed, it is then necessary for the Cosmetics Regulation to be reviewed so the regulations also cover endocrine-disrupting properties The process for updating substance rules in the Cosmetics Regulation A change to a substance rule in an annex to the Cosmetics Regulation is generally initiated through the submission of information on recent findings concerning one or more substances to the Commission (step 1, Figure 1). This information can, for example, come from a Member State that has identified problems with, or has new findings about, a particular substance and therefore believes that the substance needs to be investigated for a possible restriction or a ban. Information can also come from a company or an industry organisation that would like to have a safety assessment of a new substance. The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 9 th revision (ref 21) provides the Commission with guidance on which documentation is needed for such an investigation. 19 8

9 1) Information about new findings is received by the Commission 2) The Commission requests a scientific opinion from SCCS 3) SCCS investigates the documentation and produces an opinion 4) SCCS submits the scientific opinion for public consultation 5) Final opinion from SCCS to the Commission 6) The Commission prepares a working document as a scientific basis for a future regulation. The basis is discussed by the working group 7) The Commission prepares a draft regulation. The draft is discussed in the working group 8) The Commission submits the regulation proposal for public consultation 9) The Commission sends the proposal for regulation 10) Voting takes place in the Standing Committee 11) The European Parliament and the Council assess the proposal 12) The Commission adopts the proposal 13) The new regulation enters into force 14) The new regulation is applied to products Figure 1. Description of process steps for updating the substance rules in the Cosmetics Regulation. The process is initiated by a Member State or company submitting information on recent findings, thereby requesting the Commission to investigate. The Commission prepares a request for a scientific opinion (a mandate) to the SCCS to investigate the substance or substances in question (step 2). This mandate is based on the documentation submitted to the Commission. The Cosmetics Regulation does not 9

10 state whether the Commission must always request opinions when information has been received, or whether the Commission has the option of refraining from doing so despite the fact that signals about a substance have been received. The Scientific Committee on Consumer Safety (SCCS) is the current name of the scientific committee tasked with issuing opinions on the safety of various substances when used in cosmetic products. The SCCS was preceded by the Scientific Committee on Cosmetology (SCC), the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) and the Scientific Committee on Consumer Products (SCCP). These committees were also tasked with issuing opinions on the safe use of substances in cosmetic products. The SCCS consists of independent experts in various scientific areas who are appointed following personal applications by the experts to the European Commission. According to the Commission s decision, 20 the Committee s assignment includes providing the Commission with scientific opinions concerning risk assessment in the cases stated in Community legislation and, at the request of the Commission, providing scientific advice on issues of particular relevance to public health, consumer safety and the environment. The SCCS investigates the documentation and produces an opinion stating whether a certain use of the substance is safe (step 3). The opinion is based both on the documentation received from the companies via the Commission and sometimes also on documentation produced by the SCCS on its own initiative. If the documentation is incomplete, the SCCS might request supplementation via the Commission. The SCCS submits its opinion on the scientific documentation for public consultation (step 4) and publishes this on the SCCS website. 21 During the public consultation, the opinion is open for all to comment on, and the consultation usually continues for around 8 12 weeks. After the public consultation, the SCCS can revise its opinion depending on the comments that have been received during the consultation. Following this, the SCCS submits its final opinion to the Commission (step 5). The next step is the Commission s preparation of a working document as a basis for the future regulation of a substance (step 6). The document contains both the justification for provisions in the form of scientific opinions and the design of the regulation. The document is discussed by the Working Group on Cosmetic Products. This working group consists of representatives of the Member States, the Commission, the industry, industry organisations and interest organisations. After being treated in the working group, a proposal can be referred back to the SCCS for a new opinion, where necessary. The next step is for the Commission to prepare a draft regulation for the substance in question (step 7). This draft is also discussed in the Working Group on Cosmetic Products. The purpose of the meeting is only to discuss the regulation, but there are also discussions on the scientific documentation, and there might be a need to refer the draft back to the SCCS. After the working group completes its treatment, the Commission submits the regulation proposal for public consultation (step 8) and publishes this. 22 If the proposed regulation entails restricting the use of a substance, the public consultation must be open for at least 12 weeks. The Commission then remits the regulation proposal within the Commission and sends it to the WTO for notification in accordance with the WTO Agreement on Technical Barriers to Trade (TBT) (step 9). Notified rules cannot be adopted until three months after they have been notified. In this step, the Commission also produces a translation of the regulation into all the official languages. 10

11 The next step in the process is a vote on the final proposal. This takes place in the Standing Committee on Cosmetic Products (step 10). This Committee consists of representatives of the Member States, and the Commission holds the post of chair. Advancement of the proposal requires the majority of Member States (weighted voting) to support the proposal. After the Standing Committee has voted in favour of the proposed new regulation, the Commission shall without delay submit the proposal to the European Parliament and the Council for control and for assessment of whether or not the Commission has exceeded its powers (step 11). The Parliament and the Council then have three months to protest against the proposal. If neither the Parliament nor the Council has opposed the regulation proposal within this time, it is adopted by the Commission (step 12). After the proposal has been adopted by the Commission, it is published in the Official Journal of the European Union and generally enters into force 20 days after publication (step 13). If the regulation entails a substance being permitted or restrictions on a substance being lightened, the regulation generally begins to apply immediately, but if the regulation entails restrictions on the substance s use, it might take up to 12 months for all products on the market to comply with the requirements (step 14). Time limits for the specific regulations are negotiated in steps 7 and 10 and are set according to the degree of health risk that exists. The length of time the process takes to bring about a change for an individual substance varies greatly. For the six latest changes introduced, it has taken between 3 and 14 years from the submission of documentation to the Commission for SCCS evaluation to a provision for the substance entering into force. The substance rules that have been the most time-consuming are those concerning zinc oxide as UV-filters (14 years), the restriction of use of diethylene glycol monoethyl ether (DEGEE) (12 years) and the expanded use of ethyl lauroyl arginate HCl (ELA) as a preservative in mouthwashes (more than 11 years), see Annex Legal regulation of the process for the change procedure Parts of the process described in Figure 1 are regulated in the following provisions. Article 31(1) of the Cosmetics Regulation states that where there is a potential risk to human health, arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis, the Commission may, after consulting the SCCS, amend Annexes II to VI accordingly. Article 31(2) further states that the Commission may, after consulting the SCCS, amend Annexes III to VI and VIII for the purposes of adapting them to technical and scientific progress. The measures referred to in Articles 31(2) and 31(2), designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure referred to in Article 32(3). Article 31(3) in turn states that where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. However, this decision has been replaced by Regulation (EU) No 182/2011. Article 12 of that Regulation states that the effects of Article 5a of Decision 1999/468/EC shall be maintained for the purposes of existing basic acts making reference thereto. Article 13 further states which rules shall apply where basic acts adopted before the entry into force of this Regulation provide for the exercise of implementing powers by the Commission in accordance with Decision 1999/468/EC. Article 13(1) (e) states that where the basic act makes reference to Articles 7 and 8 of Decision 1999/468/EC, Articles 10 and 11 of Regulation (EU) No 182/2011 shall apply. 11

12 3. Investigation of the need for further restrictions of substances The focus of this part of the investigation has been to identify the need for restrictions of the substances referred to in Annexes III VI to the Cosmetics Regulation. These Annexes cover approximately 500 different substances. Hair dyes and fragrances are substance groups for which health risks have already been noted and where extensive investigations have recently been conducted at the EU level. The Medical Products Agency assessed that the investigation of the substances with restrictions listed in Annex III was less urgent since current scientific documentation usually exists to support their use and the design of rules. Among the remaining substances, the group colourants was selected for continued evaluation in accordance with the reasoning below Focus on the colourants list (Annex IV) For the substances listed in Annex IV (colourants), Annex V (preservatives) and Annex VI (UV-filters), there were both arguments for and against their being selected as a focus area in this assignment. Based on the following reasoning, the Medical Products Agency assessed the arguments for focusing on the colourants in Annex IV to be greater. However, the argumentation does not rule out the need for investigating the annexes listing preservatives or UV-filters in their entirety. Annex 4 to the present report gives the whole of Annex IV. Arguments for focusing on substances in Annex IV; 153 colourants Colourants as a group have not been addressed by other investigations. The documentation for the substance regulation is often based on outdated opinions or non-updated opinions and in some cases there are even no opinions from the Scientific Committee. Some substances are prohibited in hair dyes but have not been recently reviewed for use in other cosmetic products. The regulation of colourants is complex. Some appear in several of the annexes. This has created a lot of questions from consumers and companies. Colourants have high levels in some products that are applied to the body, e.g., lipstick, face paint, make-up. Some colourants have been prohibited in foods but are permitted for use in cosmetics, i.e. they appear in Annex IV. More than 50 azo dyes are permitted in cosmetic products. Only nine of these are approved in foods or in pharmaceuticals. The list of colourants is also applied in the regulations for tattoo inks. Arguments for or against focusing on substances in Annex V; preservatives Certain preservatives can have allergy-related issues. These preservatives are biologically active substances. However, the Medical Products Agency considered there to be a relatively large amount of current data at present since: the Danish authority has recently conducted a comprehensive investigation of preservatives in cosmetic products. 23 The government assignment being conducted by the Swedish Chemicals Agency includes the evaluation of 14 chlorinated preservatives (including triclosan) 16 12

13 A lot of work is being done at the EU level regarding preservatives. The list of preservatives is based on documentation in the form of relatively current SCCS opinions. This means that many substances are regulated as regards use and levels, even if there is also a lack of updated documentation in part. Some preservatives are also regulated in the Biocidal Products Regulation. Arguments for or against focusing on substances in Annex VI; UV-filters The use of products containing UV-filters is widespread in the population, also among young children. These substances are relatively frequent not only in sun protection, but also in anti-wrinkle creams and often in products used on a large part of the body. However, the substances used most in cosmetic products have been recently reviewed by the SCCS Colourants that should be prioritised for further review In order to identify colourants in need of further review, the Medical Products Agency produced criteria for which colourants are most urgent to investigate and possibly restrict. The criteria can be based on which scientific documentation exists for permitting them, whether new scientific findings exist, whether there are restrictions in other legislation and what we know about their use. Therefore, as regards scientific documentation, the following should be prioritised: Substances that have no opinions at all from the Scientific Committee (86 substances). Substances that only have older opinions from 1986 or soon thereafter. Substances that have later opinions, but where the Scientific Committee has objections. Priority should also be given to substances where New scientific information has been published concerning health effects. As regards regulation within other product areas, the following should be prioritised: Substances that have been permitted as food colours, but which are no longer permitted. Substances with self-classification for some types of hazards according to the CLP Regulation. Azo dyes since 50 substances are permitted in cosmetics, only 9 azo dyes in foods. Since no aggregated information on the use of these substances in products is available in any database or similar, substances should be prioritised that Were declared in a random sample of some make-up products intended for children and some lipsticks. Corresponding criteria can also be used to assess that substances are less urgent to investigate. This applies to the following: Substances that the SCCS has assessed recently and did not object against, Substances that may only be used in products that are rinsed off (36 substances), resulting in lower exposure. Substances that are permitted in foods (34). 13

14 Based on these criteria, the Medical Products Agency has examined the colourants in Annex IV. The overall assessment is presented in Annex Changes to the regulation for permitted colourants The EU has had a common regulatory framework for cosmetic products for over 40 years, and over these years several changes have taken place regarding the colourants that have been permitted or restricted, see Figure 2. Above all, structural changes of the lists have been implemented in instalments between 1976 and After 2009, no changes to Annex IV have been implemented. 14

15 1982 Minor changes to Annex III, Part 2 Extensive changes to Annex IV, Parts 2 and 3, to correct for colourants that were not used 1983 Lakes and salts for some colourants become permitted in Annex III, Part Annex III, Part 2 is replaced and renamed List of colouring agents allowed for use in cosmetic products Two provisionally permitted colourants were moved from Annex IV, PART 2 to Annex III, PART 2 and became permitted Annex IV, Parts 2 and 3 are merged into Annex IV, Part Renumbering of the annexes. The previous Annex III, Part 2, becomes Annex IV, Part 1. Annex IV subsequently includes only colourants One provisionally permitted colourant was moved from Annex IV, Part 2 to Annex III, Part 2 and became permitted Four colourants were removed completely 1989 Nine provisionally permitted colourants were removed from Annex IV, Part One colourant is entered into Annex IV, Part 2, and six are removed from it Four colourants from Annex IV, Part 2 are transferred to Annex II and become prohibited 1991 Four colourants are deleted from Annex IV, Part 1 One colourant is added to Annex IV, Part Extension of some colourants in Annex IV, Part 2 One colourant is entered into Annex IV, Part 2, and five were removed from it One of the colourants from Annex IV, Part 2 is transferred to Annex II and becomes prohibited The colourant with CI is prohibited due to carcinogenic properties, Annex II, ref no 386 Three azo dyes are removed from Annex IV, Part 1 because they release carcinogenic aromatic amines One colourant containing iodine is deleted from Annex IV. The parties concerned do not defend its use Figure 2. The technical adaptation of Annexes III and IV in Directive 76/768/EEC concerning the regulation of colourants in cosmetic products in Changes have taken place in , , , , ,28, , , , ,33, , and Scientific evaluations have taken place at other times. When the Cosmetics Directive entered into force in 1976, 311 colourants were permitted. 3 The substances were divided according to area of use and were regulated in the annexes. The colourants listed as provisionally permitted would continue to be investigated in order that they would either: Be permitted or prohibited (moved to the annex with the ban list). 15

16 Remain in the annex for a further three-year period for continued evaluation. Be removed from all annexes (i.e. not regulated in cosmetic products). The investigation continued until 31 December The technical adaptation of the annexes to the Cosmetics Directive has continued since then. In 1982, further changes were adopted so that the lists would correlate better with the colourants that were used in the production of cosmetics. 37 In 1986, the structure of the annexes was changed resulting in 159 colourants being permitted in cosmetic products and 24 colourants being permitted provisionally. 27 A total of 183 colourants were regulated in the Cosmetics Directive s annexes in 1986, which meant that 124 colourants had been removed since Further change of the structure took place in 1988 when colourants for decorative cosmetics were assigned their own annex. 29 Colourants that were permitted for use in cosmetic products were separated into two sub-annexes, one of which lists provisionally permitted colourants. In 2009, the Cosmetics Directive became a Regulation 4. As mentioned above, this Regulation began to be applied in July 2013, and the colourants annex was then given the structure it has today. Scientific evaluations of colourants A more extensive risk assessment of the colourants was reported in 1986 when the SCCS had evaluated a greater number of colourants. 27 Just over 60 opinions were produced for the total of 153 colourants that are on the list today. Subsequently, only individual evaluations have been made concerning colourants in Annex IV ( , , ). These evaluations have not led to rule changes for those substances The hair dye strategy In the last 10 years, the EU has implemented a hair dye strategy which entailed a comprehensive evaluation and regulation of the use of permanent hair dyes and bladder cancer risk. 39 The work began with the Commission making an inventory of which hair dyes that were used or had been used, resulting in a list of 318 substances. Evaluation and regulation then took place in three different steps. The first step involved the industry submitting documentation for the different hair dyes for a scientific evaluation. Since many of the 318 hair dyes were no longer in use, the industry found no reason to produce data for these. For 201 substances, no documentation was received. 17 of the 201 substances were already listed in Annex II and thereby prohibited. The remaining 184 substances were also listed in Annex II of non-permitted substances. However, lack of information is not synonymous with their constituting a safety risk. The second step evaluated the documentation for the 117 substances for which the industry had submitted documentation. This work took place in Initially, a special annex was created in which hair dyes were provisionally permitted pending a final statement. In , changes were implemented by means of 13 different amending Directives to the Cosmetics Directive. The provisionally permitted annex was emptied of content and all substances transferred to either Annex II or to Annex III. The third step investigates the combination of different ingredients, and the work is in its final phase. When the strategy is completed, all permitted hair dyes will be listed in Annex IV. No other colourants will then be permitted in hair dye products. 16

17 Double regulation within the Cosmetics Regulation Work with the hair dye strategy has not covered the general use of the colourants listed in Annex IV, which has meant that some colourants are under double regulation. Annex IV permits 37 substances as colourants in cosmetic products at the same time as Annex II prohibits their use as a hair dye, see Figure 3. The reason why some of the substances were also entered into Annex II was that information had not been received for these in the hair dye strategy. Number of colourants in total regulated in Annex IV Number of these regulated in other annexes Type of regulation 37 in Annex II Prohibited to use as hair dye in Annex III Restriction on use as hair dye 2 in Annex VI Permitted to use as UV-filter Figure 3. Regulation of colourants in the Cosmetics Regulation. Some substances are regulated in several of the Regulation s annexes, while 106 of the substances in Annex IV are only regulated in this annex Regulation of colourants in foods and pharmaceuticals In foods, all added colourants must be approved, and today there are about 40 such colourants. Some foods may not be coloured at all, such as foods for infants and young children. Before Sweden joined the EU, colourants in foods were regulated nationally. In 1975, the National Food Agency reviewed the use of colourants in foods. This resulted in the introduction of restrictions, such as permitted levels. The use of azo dyes was prohibited in Sweden in 1980 with very few exceptions in limited foods. When Sweden joined the EU, a derogation was requested from the then recently adopted Directive 94/36/EC so that azo dyes would continue to be prohibited in Sweden. After the Commission had rejected this request, the ban was lifted in 1998, and today nine azo dyes are permitted in foods. The regulation of colourants in foods has recently been reviewed since the assessments that formed the basis of their being permitted were considered obsolete. The Commission therefore considered there to be a need for a systematic reconsideration of all approved food additives to ensure that current safety assessments were still valid. The Commission asked the European Food Safety Authority (EFSA) to reconsider all food additives that were approved within the EU. In , the EFSA Panel on Food Additives and Nutrient Sources (ANS) 40 evaluated the 41 food colours that were permitted. 41 The evaluation resulted in the acceptable daily intake being lowered for several substances, the maximum permitted levels being lowered for three substances and one substance being prohibited. 17

18 Directive 2009/35/EC on the colouring matters which may be added to medicinal products establishes that there is no reason, on health grounds, why the colouring matters authorised for use in foodstuffs should not also be authorised for use in medicinal products. Therefore, the Member States shall only authorise the colouring of medicinal products for human and veterinary use if they are covered by Annex I to Directive 94/36/EC on colours for use in foodstuffs Published scientific information concerning health effects For a selection of colourants occurring in the Medical Products Agency s random sample of children s products, a number of searches were performed for scientific information from the year The searches were performed in a number of databases by the Medical Products Agency s information retrieval specialist, see Annex 2. The searches showed that a handful of colourants have a relatively large amount of data from the year The colourants that stand out are CI (Sunset yellow), CI (allura red), CI (tartrazine), CI (Blue 1) and CI (erythrosine). However, several of the studies tested mixtures of several colourants, and study results for individual colourants are not as common. The searches performed by the Medical Products Agency in this assignment show that scientific documentation on the health effects of colourants is relatively rare. The most common search results concern use and levels in foods, textiles, etc Use of colourants Only the colourants listed in the annexes to the Cosmetics Regulation may be used in cosmetic products. For the colourants in Annex IV, conditions are stated for their use in the categories Product type/body part, Maximum concentration in ready for use preparation and Other. There are Product type/body part restrictions for 59 substances in the form of three options; Rinse-off products (36 substances) Not to be used in products applied on mucous membranes Not to be used in eye products Maximum concentration in ready for use preparation is only stated for 5 of the 153 substances. Under the category Other, purity requirements are stated for 51 substances. Because no maximum levels are stated, it is probable that the manufacturers perceive the regulation to mean that the substances can be used in the products at any level at all, except for the 5 substances that have restrictions on level. SCCS opinions from 1986 often state that the substances are used in concentrations of approximately 0.1% (between %). 27 However, the SCCS has not adopted a position on whether the used concentrations are to be maximum permitted levels or whether higher concentrations can be accepted. An indication that the permitted colourants in cosmetic products are perceived to be thoroughly investigated and without health risks, despite this being highly questionable, is found in the area of tattoo inks. Tattoo inks are not covered by the provisions for cosmetic products, but the Council of Europe Resolution (ResAP) from refers to Annex IV of the then Cosmetics Directive, something which was later transposed into national legislations for tattoo inks in some countries, including Sweden. The provisions that follow ResAP state that colourants with some kind of restriction in product type under Annex IV to the Cosmetics Regulation may not be used in tattoo inks, which 18

19 indicates that the other colourants in Annex IV to the Cosmetics Regulation can be used and expected to be safe in tattoo ink. The exposure entailed by the colourant in tattoo ink is more risky compared with use in cosmetic products since its application is permanent and made in the skin Presence of colourants in random samples For a supervisory guidance project in spring 2016, the Medical Products Agency purchased six randomly selected make-up products that were especially intended for children. A review of the lists of contents on these make-up sets for the skin showed that 23 colourants were used in these products, of which several substances were present in several parts (e.g., powder, lip gloss), see Figure 4. The Medical Products Agency has also examined the declaration of content in six randomly selected lipsticks. There were 17 different colourants in the lipsticks. A total of 26 different colourants were used in these make-up sets and lipsticks. Figure 4 Colourants present in lipsticks and in make-up sets especially intended for children. Some colourants were present in several parts of make-up sets (e.g., powder, lip gloss). Only two of these colourants have been reviewed by the SCCS in recent years, in 2010 and Four substances only have SCCS opinions from 1986, but for the remaining 20, no opinions from the SCCS can be found. This review of the above-mentioned cosmetic products shows that these colourants are in use and that a new scientific review is therefore justified Colourants classified according to the CLP Regulation Suppliers of chemicals are to classify, label and package their chemical substances and mixtures in accordance with the CLP Regulation. 9 If a supplier places a hazardclassified substance on the market, it is to notify the classification and labelling to ECHA within one month. In most cases, the supplier classifies their own substance or chemical mixture, a practice known as self-classification. In some cases, an EU-wide decision is made for a chemical, known as harmonised classification. These harmonised classification decisions are obligatory for the suppliers of these substances or mixtures to apply. Harmonised classification often refers to the most hazardous substances; usually with carcinogenic, mutagenic, toxic for reproduction or respiratory sensitising properties. The harmonised classifications aim to protect human health and the environment. 19

20 ECHA s classification and labelling register is a database containing classification and labelling information on notified and registered substances from manufacturers and importers within the EU. In order to examine whether the colourants permitted in cosmetic products have been classified, the Medical Products Agency performed searches in the register. These searches showed that 57 of the 153 colourants in Annex IV to the Cosmetics Regulation have some kind of self-classification. Only two of the colourants have harmonised classifications, zinc oxide and aluminium, but these classifications do not concern health. It is difficult to determine how well these self-classifications indicate that the colourants are a hazard, as the number of registrants that had notified a particular classification can vary greatly for the same substance. However, when a larger ratio of the total number of registrants for a substance is in consensus and the classification is the same, it is perceived as more probable that the classification is consistent with the substance s intrinsic hazard. In this assignment, the Medical Products Agency has assessed that it is relevant to take note of the colourants for which 50% or more registrants have selfclassified the colourants as sensitising (SkinSens), carcinogenic, mutagenic or toxic for reproduction (carc, mut, repr) or system toxic (STOT). This assessment shows that six colourants should be noted, see Table 1. Table 1 Number of colourants in Annex IV (CI items) per hazard class that have self-classifications according to the CLP Regulation. Colourant CMR SkinSens STOT Class and number CI X X SkinSens1/STOT_RE2 (29/55) CI X SkinSens 1 B (69/191) & SkinSens1 (36/191) CI X Carc2 (65/130) CI X STOT_RE2 (66/97) CI X STOT_RE2 (30/44) CI X STOT_SE3 (298/572) Azo dyes In recent decades, attention has been given to azo dyes since they are associated with certain health risks. The colourants list in Annex IV to the Cosmetics Regulation contains 50 azo dyes, and only four of these have been reconsidered as cosmetics colours after There a restrictive stance regarding the use of azo dyes in respect to food, and there has been extensive work to reconsider and regulate the use of azo dyes in foods. Some azo dyes were prohibited in foods as early as the 1970s. These are still found in Annex IV to the Cosmetics Regulation without having been reconsidered. However, exposure to azo dyes differs between their use in foods and cosmetic products. Today, nine azo dyes are permitted in foods and 50 in cosmetic products. Azo dyes is a collective name for a large group of synthetic colourants with wide use in, e.g., foods, goods, pharmaceuticals and cosmetic products. Common to azo dyes is that they contain a chemical structure that is called azo group and that is often bound to an aromatic ring. Azo dyes can be broken down into aromatic amines; arylamine. Several of these aromatic amines have been classified as carcinogenic, mutagenic and/or toxic for reproduction. A list of 22 aromatic amines that can be formed as degradation products from azo dyes are included in the REACH restriction rules, and these may not be present in textile goods. 43 Mammals metabolise azo dyes in the liver through reductive cleavage to amines, but this has also been shown to occur in skin absorption in 20

21 mice, guinea pigs and humans 44 and in reaction with skin bacteria in rats 45. However, not all azo dyes are broken down into harmful substances. Azo dyes in foods and pharmaceuticals There are nine azo dyes that are approved for use in foods. Seven of these may be used in almost all foods that may be coloured, but two of them may only be used in some individual foods (E 123 and E 180). A study from the United Kingdom has indicated that some azo dyes in foods can give children concentration difficulties. This study has then been evaluated by EFSA, which believes that it is not clearly scientifically proven that these substances are harmful. Nevertheless, negotiations at the EU level resulted in foods containing certain azo dyes having to carry the following labelling; May have an adverse effect on activity and attention in children. 46 Azo dyes in foods can also give rise to hypersensitivity reactions such as asthma, hives and eczema in people with skin problems. 47 Especially notable is the azo dye Red 2G (E 128), which was previously permitted as a colourant in certain foods. EFSA evaluated the substance in 2007, basing it on the conclusions of the European Union risk assessment report on aniline 48. That report concluded that aniline should be considered as a carcinogen since a genotoxic mechanism cannot be excluded. Since the colourant Red 2G (E 128) extensively degrades into aniline, EFSA concluded that the substance should be regarded as a safety concern and EFSA withdrew the ADI for the colourant Red 2G. 49 The substance was then prohibited as a food colour through Regulation (EC) No 884/2007 on emergency measures suspending the use of E 128 Red 2G as food colour. 50 The same substance is permitted for use as a colourant in cosmetic products, but it is then called CI 18050, and the substance is listed as No 38 in Annex IV to the Cosmetics Regulation. Even though the exposure routes differ, it is remarkable that an EU body s evaluation and assessment that the substance should be regarded as a safety concern does not have a greater impact on its use in another consumer product area such as cosmetic products. The use of azo dyes in pharmaceuticals has mainly been discussed in oral medications for children on the basis of their potential risks of side effects. EMA guidance from 2007 highlights that azo dyes are considered to be colourants with a documented safety risk and that their use should be restricted in pharmaceutical products for children when they are only added for aesthetic purposes. 51 Azo dyes in cosmetic products In Annex IV, 50 out of 153 colourants are azo dyes (CI numbers ). Many of the azo dyes that are permitted in cosmetic products have been evaluated on the basis of their use as hair dyes. Only four of these azo dyes have been re-evaluated on the basis of their use as a permitted colourant in all cosmetic products. An evaluation was performed in 2002 since Germany considered it important to re-evaluate four of the azo dyes. This resulted in the Commission tasking its Scientific Committee on Cosmetic Products, then called SCCNFP, with evaluating the safety of the following four azo dyes: CI CI CI CI The re-evaluation was based on concerns that these substances form carcinogenic amines when they are metabolised. 52 The SCCNFP s assignment was to take a position 21

22 on whether the substances were assessed to be safe and could thereby remain as permitted colourants in Annex IV or whether any restrictions were to be recommended. The evaluation only covered the possible mutagenic and carcinogenic properties of the azo dyes. The SCCNFP s conclusion was that all the colourants were expected to degrade into carcinogenic amines. This degradation could take place both on the surface of the skin in reaction with skin bacteria, through metabolism in the skin in conjunction with skin absorption or in the liver after absorption into the body. Data for the substances genotoxicity was assessed to be insufficient. Only the substance CI was examined with regard to carcinogenic properties, but there too the studies were assessed to be insufficient. The SCCNFP s conclusion was that no risk assessment could be carried out due to the lack of sufficient data for the products purity, toxicity and exposure. Using the available literature, the SCCNFP made the assessment that the four azo dyes, and other azo dyes that can be broken down into carcinogenic aromatic amines, can pose a health risk to consumers. The substances CI 12150, CI and CI were therefore removed from Annex IV and may no longer be used as (decorative) colours in cosmetic products. As a result of the hair dye strategy, the three substances above have today been placed in Annex II, where they have been prohibited for use as hair dyes. In February 2004, the industry submitted new data for substance CI 26100, and the Commission tasked its Scientific Committee, then called SCCP, with once more evaluating the risks of using CI as a colourant in cosmetic products and with taking a position on whether further restrictions were necessary for the substance. This time, the SCCP s comments were that the data submitted was still insufficient for being able to assess the risks of using CI as a colourant in cosmetic products. The data that was lacking included skin absorption studies of CI and its metabolite 4- amino azobenzene, as well as studies of the substance s toxicity after repeated exposure and harmfulness to the unborn child, known as teratogenicity. The SCCP pointed out that studies were needed to assess the local mutagenic/carcinogenic potential of the substance CI when applied on the skin. No rule change has been implemented at the EU level for the substance CI 26100, but it is still a permitted colourant in Annex IV to the Cosmetics Regulation Overall assessment of colourants The Medical Products Agency has assessed, evaluated and aggregated the various criteria for all colourants and entered them into the table in Annex 2. This has yielded an overall prioritisation with values from 2 to -4. The more criteria that have been assessed to be deficiencies, the lower the prioritisation. More detailed information about this can be found in the table. This overall prioritisation shows that especially the following 15 substances have many deficiencies and should be prioritised for further investigation: primarily CI 12085, CI 20470, CI and CI 45410, but also CI 10316, CI 13015, CI 14270, CI 14815, CI 15850, CI5980, CI 15985, CI 16290, CI 27755, CI and CI CI An azo dye for which there is no opinion at all from the SCCS and that the Medical Products Agency has found in products on the market and for which there is a scientific report of allergic contact eczema. Annex IV sets a maximum concentration of 3%. 22

23 CI An azo dye that the SCCS was not able to assess in 1986 due to lack of information. Has been self-classified as skin sensitising in CLP. CI An azo dye that was examined by the SCCS in 2005, but for which it could make no assessment and requested supplementary information no later than March No supplementary information was received. CI A colourant for which there is no opinion at all from the SCCS. The substance has been assessed in CLP self-classification to have specific target organ toxicity following repeated exposure. The substance was found in the Medical Products Agency s random sample and is thus in use. CI A substance that was assessed by the SCCS in The substance was assessed to be safe at concentrations of 1.0% and 0.2% in various types of hair colourants. At the same time, the substance was assessed to be a potent skin sensitiser. The Medical Products Agency s MoS calculations for use in lipstick yield MoS values of between 51 and 333 depending which level is in the lipstick, see Annex 3. MoS values should generally exceed 100. CI An azo dye for which there is no opinion at all from the SCCS. The substance is no longer permitted in foods. CI An azo dye for which there is no opinion at all from the SCCS. The substance is no longer permitted in foods. CI An azo dye for which there is no opinion at all from the SCCS. The substance is no longer permitted in foods. CI An azo dye that was reviewed by the SCCS in No NOAEL/LOAEL could be derived from submitted studies. However, on the basis of effect level, the SCCS was not able to assess that the substance entailed any risk for use at a maximum of 0.4% in hair dye. The SCCS recommended that a review be conducted of the safety for use in other products, but no such review has been conducted. The Medical Products Agency s margin of safety calculations for use in lipstick yield values of between 170 and 1111 depending which level is in the lipstick, see Annex 3. But here, the Agency used effect level rather than NOAEL, which is recommended for the calculation of MoS. The substance was found in the Medical Products Agency s random sample of some lipsticks and make-up sets for children. The substance may be used in foods, but only for edible cheese rusks. CI An azo dye for which there is no opinion at all from the SCCS. The substance is no longer permitted in foods. 23

24 CI An azo dye for which there is no opinion at all from the SCCS. There are many new scientific publications for this substance regarding various biological effects. The substance was found in the Medical Products Agency s random sample of some lipsticks and make-up sets. The substance is permitted in foods, but is required to have a special warning. CI An azo dye for which there is no opinion at all from the SCCS. The substance is no longer permitted in foods. CI An azo dye that the SCCS requested more information about in 1986, but this was not received. The substance is no longer permitted in foods. CI The SCCS has not given an opinion on this substance. The substance has been considered in CLP self-classification to have specific target organ toxicity following repeated exposure. CI The SCCS has not given an opinion on this substance. The substance has been assessed in CLP self-classification to have specific target organ toxicity following single exposure. Even if these 15 substances stand out as having particularly inadequate documentation, the aim must be for there to be a current opinion from the SCCS on all colourants permitted under Annex IV to show that they are safe to use in all products for which they have been approved. 4. Investigation of faster adaptation of new findings and hazards The focus of this part of the investigation was to identify improvement proposals with the aim of ensuring that the substance lists in the Regulation are kept current and updated in accordance with scientific findings. The investigation has also identified proposals for speeding up the process of updating the substance lists in the Cosmetics Regulation and for how the Medical Products Agency could increase the opportunity for influence at the right time Use of positive lists The Medical Products Agency believes that the current design of the annexes with a grouping of substances is justified. The lists are very useful for the Agency s own supervisory work and they facilitate communication with both consumers and companies regarding which colourants, preservatives and UV-filters are permitted in cosmetics. In order for positive lists to ensure that only safe substances are used in cosmetics, it is necessary for the assessment of the substances to be based on current scientific findings. The scientific documentation used for regulating foods, pharmaceuticals and chemicals should also form part of the documentation for assessing substances in cosmetic products. Recently, colourants have been evaluated for use as 24

25 hair dyes but not for the substances general use in cosmetic products, something which affects the credibility of the positive list. The Medical Products Agency perceives the substances listed in Appendices IV VI to be considered safe to use. One indication of this is that the regulations for tattoo inks refer to these lists. During industry dialogue with representatives of some cosmetics companies, their views were requested regarding the function of the positive lists. The meeting revealed that the companies, as expected, use the various positive lists as a starting point, a first step in the formulation process, and then with respect to the specific purposes the lists have (colourants, preservatives and/or UV-filters). The companies stress that the lists are a starting point for further safety evaluation. The companies are generally positive about the legislation for cosmetic products having these lists Improvement proposals regarding the presence of substances on the lists The Medical Products Agency proposes That the Commission has an evaluation performed for all the colourants rules in Annex IV in order to determine whether there is scientific documentation for continuing to permit the substances with the restrictions and conditions stated in the lists. A review is also needed for Appendices III, V and VI. The Commission should either request that the SCCS performs the entire evaluation or that the Member States perform an initial review of various substance rules. The documentation that the Member States can contribute is then sent to the SCCS for final assessment. The Commission cannot impose the Member States with any obligation to carry out investigations or measures. But the Member States have responsibility for monitoring compliance with the Regulation so that only products that are safe for human health are made available on the market (Articles 3 and 22). This means that the Member States are responsible for monitoring all constituent substances that are used and new findings about the substances. A voluntary commitment by the Member States to monitor various substances would facilitate this task. The evaluation should entail: 1. Inventory of the scientific documentation justifying the substance s being regulated in Appendices IV VI to the Regulation. It is important to point out whether the substance lacks underlying documentation or whether previous SCCS investigations have pointed out the need for supplementary information that has not been provided. 2. Examination of whether there is scientific documentation for the substance in other regulations, such as those covering chemicals, foods or pharmaceuticals. 3. Examine whether any new classification under CLP has been made, e.g., CMR or sensitising properties. Article 15 of the Cosmetics Regulation is treated when initiatives are to be taken with regard to CMR. 4. Search for what has been published about the substance in scientific articles. A common view among the Member States regarding relevant criteria should be produced and regarding documentation on the data needed for further evaluation by the SCCS. It is also desirable for the evaluation to contain: 25

26 5. Inventory of the substances use in order to remove outdated substances, such as substances containing mercury (Annex V), which is no longer used. This inventory should tentatively be implemented by the Commission in collaboration with industry organisations. 6. Horizon scanning in the form of information including the occurrence of undesirable effects from using the substances, for example information from contact dermatology associations. The information obtained will form the basis for initiating a new assignment for the SCCS. It is estimated that points 1 4 will take about one week for one person to carry out for one colourant since there rarely appears to be much information published on the health risks of the colourants, see section There are probably synergies if the work is done for several similar substances at the same time. The time expenditure for points 5 6 is more difficult to estimate as the extent of documentation is likely to vary greatly Improvement proposals for maintaining the relevancy of the substance lists Maintaining scientifically relevant substance documentation requires both horizon scanning and regular review. The Medical Products Agency proposes the following measures. That the Commission requests that the SCCS systematically monitors the substance rules and identifies whether the substances are regulated in other regulations, such as those covering pharmaceuticals, foods or chemicals. It shall also be monitored whether any classification under CLP is made, e.g., CMR or sensitising properties. New findings should generally result in the initiation of a review case. At the next review of the Regulation, it is proposed that requirements on fixedterm re-evaluation of the substance rules in Appendices IV VI be introduced. At the next review of the Regulation, a clarification is also proposed whereby substances no longer in use can be removed from lists IV VI so that the annexes will be current Improvement proposals linked to the process The actual process from initiating a proposal to investigate a substance until regulation has been implemented usually takes several years, even though parts of the process have a more or less fixed term, see section 2.3. The scientific documentation is mainly discussed in steps 1 up to and including step 6. From step 7, the discussions mainly concern the design of regulation. Some steps are open to public influence, see Figure 5. 26

27 1) Information about new findings is received by the Commission 2) The Commission requests a scientific opinion from SCCS 3) SCCS investigates the documentation and produces an opinion 4) SCCS submits the scientific opinion for public consultation 5) Final opinion from SCCS to the Commission 6) The Commission prepares a working document as a scientific basis for a future regulation. The basis is discussed by the working group 7) The Commission prepares a draft regulation. The draft is discussed in the working group 8) The Commission submits the regulation proposal for public consultation 9) The Commission sends the proposal for regulation 10) Voting takes place in the Standing Committee 11) The European Parliament and the Council assess the proposal 12) The Commission adopts the proposal 13) The new regulation enters into force 14) The new regulation is applied to products Figure 5. The steps in which the Member States and companies have the opportunity to influence proposals are marked with a light colour. The Medical Products Agency generally finds that steps 1 up to and including step 10 take a long time, with step 1 to step 5 in particular being perceived to vary greatly in time expenditure. The conditions for the working group handling step 6 and step 7 are not optimal since participants often receive the documentation at a late stage ahead of working group meetings. A procedure of sending comments after the meetings has been developed, but this does not facilitate international consensus between the Member 27