An EU ban on microplastics in cosmetic products and the right to regulate

Correspondence Email: e.kentin@law.leidenuniv.nl Abstract In January 2018, the European Commission initiated a restriction procedure on microplastics in cosmetic products. This article deals with the legal implications of a European Union (EU) restriction under the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in relation to the right to regulate in the EU and in the context of the World Trade Organization (WTO). The article argues that in the aftermath of harmonization, the legal scope for EU Member States is dependent on the definition that will be adopted as regards microplastics under REACH: the wider the scope of the restriction, the more probable it is that Member States’ action is restrained. In the context of WTO rules, similar considerations apply as regards the scope of the definition: the wider the scope of an EU ban, the more demanding it will be to satisfy the requirements under the Agreement on Technical Barriers to Trade. Providing scientific evidence is instrumental, as there is little room for the precautionary principle in both regimes.

In the absence of an international environmental agreement on plastic pollution, and in particular on microplastics, countries turn to unilateral measures, even though this kind of pollution may only be effectively tackled on a global scale. 4 We are well aware of the fact that intentionally added microplastics are only a fraction of the problem of (micro)plastic pollution. Nevertheless, we will limit our research to the restriction of microplastics in cosmetic products, as one of the most frequently adopted regulations on microplastics.
Before going into the implications for the internal market and international trade law of an EU ban on microplastics, we first discuss the national bans of microplastics in cosmetic products. Different definitions of microplastics are used and restrictions apply to different categories of products. We also refer to the developments at the EU concerning the restriction dossier currently prepared by ECHA. We acknowledge that an EU-wide ban on microplastics is far from being adopted. However, the implications of the possible EU ban for Member States' regulatory autonomy in the future should be analysed given that the scientific knowledge on microplastics is still developing and further regulatory measures may be needed. The last section explores the right to regulate in relation to WTO law, in particular the TBT Agreement. WTO case law has, in several decisions, stipulated the right to regulate, which should be balanced with the objective of trade liberalization. Would a European ban on microplastics stand the test under the TBT Agreement if challenged?
We evaluate the requirements for a WTO-compliant technical measure, in particular with an EU ban on microplastics in mind.

IN COSMETIC PRODUCTS
The existence of microplastics was first described in the journal Science in 2004, revealing that microscopic plastic fragments were widespread and increasing in the marine environment. 7 In the years since, scientists published an abundance of evidence regarding microplastics, from measuring the presence and quantity to the ingestion of microplastics by animals and presence in food chains. 8 Intentionally added microplastics, in particular those in rinse-off products, are generally discharged in wastewater streams, in most parts of the world directly into surface water, but also after treatment in wastewater facilities. 9 The release of intentionally added microplastics in cosmetic products in the environment is most effectively prevented by banning them from these products. 10 Table 1 outlines the initiatives countries have taken so far. In 2015, the first national regulation on microplastic pollution was adopted. Following legislative initiatives in several states, 11 the US Microbead-free Waters Act of 2015 prohibits the manufacture and sale of rinse-off cosmetic products that contain 'microbeads'. 12 A microbead is defined as 'any solid plastic particle that is less than five millimetres in size and is intended to be used to exfoliate or cleanse the human body or any part thereof'. 13 The Act also provides that further regulation of microbeads in rinse-off cosmetic products by federal states is not permitted and should be revoked if already in place. In this regulation, the distinction between rinse-off and leave-on products was introduced, suggesting that primarily rinse-off products would lead to disposal in waterways. 14 United States -Microbead-free Waters Act of 2015 (in force) --Rinse-off cosmetic products Microbead: any solid plastic particle that is less than 5 mm in size and is intended to be used to exfoliate or cleanse the human body or any part thereof Sweden has also announced a ban prohibiting rinse-off cosmetic products that contain plastic particles which have been added for exfoliating, cleaning and polishing purposes. 22 Plastic particles are defined as solid particles of plastic which are 5 mm or less in size and insoluble in water. 23 The Swedish notification refers explicitly to the US and French regulations and it seems that Sweden has attempted to follow the definition in these regulations.
New Zealand notified the WTO in March 2017 of its proposed ban on microbeads in 'wash-down' cosmetic products. 24 In October 2017, New Zealand announced that the proposed ban will be extended to include cleaning products, such as household, car and industrial cleaning products. 25 A microbead is defined as 'a waterinsoluble plastic particle that is less than 5 mm at its widest point ', 26 thereby tying in with the regulation in the United States and Canada. 27 However, the extension to other, non-cosmetic, wash-off products is novel.
The United Kingdom has announced four legislative proposals, Belgium has notified a voluntary sector agreement to phase out microplastics, initially from rinse-off cosmetic products, and gradually from cleaning and maintenance products. 28 The latest notification came from Italy, proposing to phase out microplastics in exfoliating rinse-off cosmetic products and detergents by January 2020. 29 As an EU restriction on microplastics is being prepared by the ECHA, and expected to be published in January 2019, we can only speculate on the definition of microplastics. ECHA has adopted a working definition, reading 'any polymer-containing solid or semi-solid particle having a size of 5 mm or less in at least one external dimension', though acknowledging that this definition is likely to evolve. 30 Although most legislation adheres to the definition that was adopted by the United Statesany solid plastic particle that is less than   human body or any part thereofwe can see variations. Canada explicitly includes hollow, amorphous and solubilized particles, with different functions, while France does not set a size limit. Most bans apply to rinse-off cosmetic products, but New Zealand extends the ban to cleaning products. The EU has declared that it will investigate all relevant products, including leave-on cosmetic products, such as make-up and sunscreen, and also cleaning products and products for agricultural and industrial use. In this article we will focus on microplastics in cosmetic products only. The definition of microplastics as well as the category of products is of crucial importance for determining what the level of harmonization is after the adoption of an EU ban. Would there be room for deviation, for example, by extending the definition to all synthetic polymers, solid or not? And would Member States be able to apply a restriction on leave-on cosmetic products? These kinds of issues are also relevant for the test whether the EU restriction would be in accordance with WTO law. If an EU restriction would depart from solid plastic particles and rinse-off cosmetic products, to more encompassing regulation, would it pass the test of Article 2(2) TBT Agreement?

MICROPLASTICS ON THE REGULATORY AUTONOMY WITH IN THE EU
Any future EU ban on microplastics under REACH will harmonize completely the conditions of manufacture, placing on the market and given the fact that much knowledge on the human health and environmental impacts of microplastics is still lacking. Moreover, at least some Member States seem to be active in regulating chemicals at the national level. 35 For example, it has been argued that France and Denmark are in the belief that they are still allowed to regulate chemicals if they consider the measures taken on the basis of REACH as insufficient. 36 Especially France seems not to limit itself to dealing with emergencies and has, for instance, adopted a mandatory nanomaterial reporting in the absence of a Union-level registration system. 37

| The concept of harmonization
Before considering in more detail Member States' possibilities for derogation, we first look at the concept of 'harmonization'. This is because the scope for Member States' action is largely based on the harmonization measure adopted under REACH. In particular, two issues arise in this context: the stage at which harmonization takes place and the extent to which the manufacture, use and placing on the market of microplastics is harmonized.  The extent to which harmonization has taken place is a more complex issue and closely related to the definition that will be adopted for microplastics by REACH. This is because the definition determines the range of substances covered by the REACH prohibition and, accordingly, the 'scope' of the prohibition. For example, the scope of a prohibition covering only solid microplastics is narrower than the scope of a prohibition covering also those that are water soluble. The same may apply for the categories to which the restriction pertains. In our opinion, the scope of harmonization will also depend on the decisions that have been made during the restriction procedure. If a form of microplastic or a certain category of products has explicitly been excluded from restriction during the procedure, we may assume that harmonization has taken place for these forms of microplastics and categories of products. Since ECHA has announced it will investigate all forms of microplastics and all products with intentionally added microplastics, an explicit decision can be expected. We can imagine that the underlying reasoning of exclusion of forms of microplastics or certain products from the restriction might also affect the scope of harmonization. A national ban will be absorbed in case the national measure falls within the EU restriction and the EU ban is wider than the national measure. This would be the situation for most national bans, if an EU ban restricts also other forms of microplastics than solid ones or if an EU ban restricts also detergents and leave-on cosmetic products and not only those that are rinsed off. In those situations, the EU ban would be wider than the national bans and, for that reason, the national regulations will be replaced by the EU ban.

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If a Member State comes to the conclusion that the national measure does not fall within the scope of the harmonization, the Member State in question is entitled to maintain in force its restriction on microplastics. This is outlined by Article 128(2) REACH, which provides that Member States may maintain in force and introduce national rules to protect workers, health and the environment in cases where REACH does not harmonize the requirements on the manufacture, placing on the market or the use. In this case, the scope of harmonization becomes essential. If an EU ban limits the restriction on microplastics to only solid plastic particles used to exfoliate or cleanse in rinse-off cosmetic products, would all other microplastics and products that do not fall under the restriction be harmonized? While we cannot predict the outcome of the restriction procedure, we presume it is essential that a restriction measure on microplastics should explicitly determine which microplastics and products it intends to harmonize and thus should define the scope of harmonization.
If we, however, assume that the EU ban does harmonize the regulation on all microplastics, issues may arise when national regulation is more stringent. In that situation, a Member State may be entitled to  The issue raising concern here is that the stance adopted in relation to the condition implies an onerous burden on Member States. In order to meet the condition, the mere desire to protect the environment is not enough: the notifying Member State must be able to demonstrate that the problem is specific for the Member State concerned due to, for example, the high population  72 Thus, the Member States are not allowed to impose more stringent measures to deal with a problem that is common for the whole Union. This conclusion raises concern especially in the context of microplastics that cause problems worldwide. Such a strict assessment may lead to the situation in which the more widespread the environmental problem is, the less likely it is that a Member State will succeed in its application for derogation. 73 Article 2 of the TBT Agreement provides the key obligations with which a technical regulation has to comply: the non-discrimination obligation, the obligation to refrain from creating unnecessary obstacles to international trade and the obligation to base technical regulation on international standards. 88 According to Mavroidis, this process should be seen as WTO members taking 'the first steps toward "rationalizing" their regulatory interventions '. 89 In the following section, we apply these criteria to a possible EU restriction on microplastics, being aware that this assessment is highly speculative. We focus on an EU ban under REACH, though

| The EU ban on microplastics as a technical regulation
In EC -Asbestos, the French prohibition of asbestos and products containing asbestos fibres was challenged by Canada. One of the issues was whether the prohibition qualified as a technical regulation under the TBT Agreement, and the AB referred to three essential 75  features of a technical regulation: reference to an identifiable product, description of product characterizations and demanding mandatory compliance. 90 Regarding an EU ban on microplastics, this issue will raise minimal debate. The national bans have been notified consistently, with the exception of the US Microbead-free Waters Act of 2015, as a technical measure, being applicable to certain cosmetic products, namely, to rinse-off products. Even if microplastics are banned as a substance in any product, rather than as an ingredient of certain products, the prohibition could be seen as a technical measure, as was confirmed by the AB in EC -Asbestos. 91 Only if all microplastics are totally banned in their natural stateas in a plain banwithout further references to products, a situation that is highly unlikely at this stage, one could question whether the element of identifiable product would be satisfied. 92 In that case, only the GATT 1994 provisions, in particular Article I on most-favoured-nation (MFN) treatment, Article III on national treatment, Article XI on quantitative restrictions and Article XX on general exceptions, would apply. It should be noted that even if a measure is consistent with the TBT Agreement, measures could still be inconsistent with GATT 1994. As indicated above, in this article we limit our analysis to consistency with the TBT Agreement.
Regarding the criterion of product characterization, all national bans lay down product characterizations, such as the size of the plastic particle and the function of rinse-off products. An EU ban on microplastics would, by defining microplastics and categories of products, fulfil this requirement. The third feature, mandatory compliance, is satisfied by the nature of the procedure under REACH: a restriction in the meaning of Article 67 REACH is a mandatory measure per se.

| Non-discrimination principles
The non-discrimination principles of national treatment and MFN treatment are included in Article 2(1) TBT Agreement, which sets out that 'in respect of technical regulations, products imported from the territory of any Member shall be accorded treatment no less favourable than that accorded to like products of national origin and to like products originating in any other country'. 93 Two steps can be distinguished: first, it has to be determined whether the relevant products are 'like'; and, second, if so, whether the measure treats them 'no less favourable '. 94 In US -Clove Cigarettes, the AB made a clear statement regarding the determination of 'likeness'. The issue at hand was whether clove and menthol cigarettes were like products, as clove cigarettes were prohibited and menthol cigarettes were not. In the panel report, likeness was determined by focusing on the objectives and purposes of the technical regulation. However, the AB chose to follow the competition-based approach, which is also used in the context of the GATT 1994 provisions. The AB stated that 'the concept of "treatment no less favourable" links the products to the marketplace, because it is only in the marketplace that it can be determined how the measure treats like imported and domestic products'. 95 The AB further referred to the considerations made in EC -Asbestos regarding physical characteristics and consumer preferences, including evidence relating to health risks, which was the underlying concern of the measure. 96 In EC -Asbestos, Canada claimed that its products with asbestos fibres should be considered as like products, though the AB found on the basis of health considerations that the physical properties of the products were very different, which would influence consumers' behaviour, and therefore products with asbestos fibres could not be seen as like. 97 The AB in US -Clove Cigarettes concluded that regulatory concerns underlying a measure 'may be relevant to an analysis of the "likeness" criteria under Article III:4 of the GATT 1994, as well as under Article 2.1 of the TBT Agreement, to the extent they have an impact on the competitive relationship between and among the products concerned '. 98 Applying this analysis to a possible EU ban on microplastics, we can observe several issues. While it might be true that the physical properties of products with microplastics will be different with regard to environmental impact, the competition-based approach of the AB in US -Clove Cigarettes will most probably lead to the finding that products with microplastics will be considered as like products.
Most consumers are not aware of the presence of microplastics in cosmetic products. This is even truer for different types of microplastics in case the definition in the EU ban would diverge from more commonly used definitions.
The second step is then to assess whether the like product is treated less favourable, covering both de jure and de facto discrimination. The AB in US -Clove Cigarettes referred to the case law estab- rather than reflecting discrimination against the group of products'. 101 The question is whether the measure 'is designed and applied in an even-handed manner' 102 and 'the particular circumstances' of the case, including the 'design architecture, revealing structure, operation, and application' of the measure, should be scrutinized. 103 Hence, it should be examined whether an EU ban would discriminate against imported products. If a detrimental impact on non-EU cosmetic products is observed, it may not be considered discriminatory if it is based on a legitimate regulatory distinction.
An EU ban should therefore be designed and applied in an evenhanded manner. The process of restriction under REACH may be essential in that respect. It has been observed that the approach of is not about whether the measure is trade-restrictive or not, but about whether it is more trade-restrictive than necessary. 106 As the phrase suggests, the measure should fulfil a legitimate objective, which includes 'the protection of human health or safety, animal or plant life or health, or the environment'. 107 According the AB in EC -Seal Products, the articulation of the objective pursued should be considered, though 'all evidence … including "the texts of statutes, legislative history, and other evidence regarding the structure and operation"' should be taken into account. 108 Furthermore, 'a Member shall not be prevented from taking measures necessary to achieve its legitimate objectives "at the levels it considers appropriate"', though the measure should also be examined as to whether it, 'as written and applied, actually contributes to the achievement of the legitimate objective pursued by the Member'. 109 As all evidence has to be taken into account, the question arises whether there is room for the application of the precautionary principle in case there are uncertainties or gaps in scientific evidence.
The TBT Agreement does not explicitly mention the precautionary principle, or a situation of insufficient evidence, like the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) does. 110 In EC -Hormones the AB concluded that although there might be some relationship between the precautionary principle and the SPS Agreement, it cannot override its provisions. 111 While the precautionary principle has not been addressed by a panel or the AB in relation to the TBT Agreement, there seems to be some room for the application in the terms 'legitimate objective' and 'assessment of risks' in Article 2(2) of the TBT Agreement. 112 The case law on the SPS Agreement shows, however, that this space is minimal and we do not expect that this will be different for the TBT Agreement. 113 Regarding the national bans on microplastics, in the notifica- In case a more encompassing ban is established, for example, by using a broader definition of microplastics than in existing national bans or by including more product categories, the trade-restrictiveness test will be more challenging. While a restriction on microplastics in cosmetic products undoubtedly leads to less microplastics in the environment, it remains to be seen, in relative terms, what the effect is on microplastic pollution in general. Successful voluntary initiatives phasing out certain microplastics in certain products and the limited contribution of cosmetic products to microplastic pollution in general could be aspects to consider within the balancing process. While we conclude below that no international standards exist, scientific consensus on the harmfulness of microplastics and the level of protection may contribute to establishing a certain level of protection as legitimate objective. This should be substantiated with data.
Although the WTO requires an assessment of the actual applied measure, we think the restriction dossier and process serves as a good preparation for a challenge under the WTO agreements.

| International standards
As the preamble of the TBT Agreement points out, international standards contribute and facilitate the conduct of international trade, thereby explicitly encouraging harmonization. 120 Article 2(4) TBT Agreement requires that international standards should be used as a basis for technical regulation, except when these standards would be ineffective or inappropriate. In two cases, the conformity of technical measures has been assessed on the conformity with international standards. In US -Tuna II (Mexico), the AB deliberated at length on the definition of standards and the international standardizing body, requiring that these bodies should be open to all WTO members. 121 Reference was made to a dolphin-safe standard, developed under a regional treaty, but the AB stated that this organization did not satisfy the requirement of being 'international', and thus not being able to develop international standards within the meaning of the TBT Agreement. So, although 'standards' may include rules, guidelines or recommendations, the threshold for being 'international' is rather high. Therefore, it seems unlikely that the definitions used in national regulations, such as those on microplastics, could function as international standards, even in case these regulations use the same standard. Also, an EU restriction measure on microplastics, harmonizing the EU market, would not qualify as an international standard. While plastic pollution has recently received increased attention, both within the EU as outside, no initiative for global regulation on microplastics has been taken so far. Voluntary initiatives of the industry pertain to phasing out certain solid microplastics in rinse-off cosmetic products, in Australia and Europe. 122 Nongovernmental organizations and scientists have criticized the narrow definition of microplastics and limited category of products.
Hence, we conclude that no international standards regarding microplastics exist that could be used as a basis for an EU ban. Concerning the regulatory autonomy within the EU, we conclude that the Member States' right to regulate first of all depends on the scope of harmonization. Therefore, Member States' scope for regulatory action on microplastics in the EU is largely dependent on the definition that will be adopted under REACH. In case the national and REACH definitions on microplastics are identical, no problems are likely to arise. By contrast, if an all-encompassing definition is used at the EU level, the Member States' scope for action is limited competition-based approach of the AB, cosmetic products with and without microplastics will be considered like products and a restriction should be non-discriminatory to products originating outside the EU, both on paper and in practice. It seems that such a distinction is not made by any of the national bans and an EU ban should follow this practice.

| CONCLUSION S
Applying the 'not more trade-restrictive than necessary' test, the outcome regarding an EU ban is less predictable due to a variety of definitions and product categories that can be adopted. The REACH restriction procedure, including the comprehensive requirements of the restriction dossier, may anticipate the balancing and weighing of the test, though the actual operation and application of the measure remain decisive. Departure from more frequently used definitions and categories of products might require additional justification in relation to the legitimate objective and alternative measures. Scientific evidence, also in the absence of international standards, could become essential in this respect.
Hence, the design of a restriction dossier under REACH, including a comprehensive impact and risk assessment of the proposed restriction and substantiated with scientific evidence, may anticipate a challenge at the WTO. But at the same time, it may deter EU Member States from implementing further national measures, as the compilation of the dossier is perceived being too burdensome. We come to the conclusion that the wider the scope of an EU ban, the more demanding it will be to satisfy the conditions of a legitimate technical measure under the WTO. A wide scope in an EU ban, implicating a higher level of harmonization, may also constrain the possibilities for EU Member States to adopt stricter national measures. We recommend that careful consideration should be given to these issues when defining the scope of the restriction on microplastics in the current restriction process under REACH.
A final point is that the availability of scientific evidence is essential for the risk assessments that are required in both regimes.