European Commission: Public consultation on a possible restriction of hazardous substances (CMR 1A and 1B) in textile articles and clothing for consumer use under Article 68(2) of Regulation EC No 1907/2006 (REACH)

Introduction

The Federation of the European Sporting Goods Industry, highly welcomes the opportunity to participate in the public consultation on possible restrictions of CMR 1A and 1B substances in textile articles and clothing under EC 1907/2006 REACH. The sweeping nature of the proposed restrictions have the potential for wide-ranging impacts on the global apparel and footwear industry, and FESI seeks to contribute information, insight, and recommendations to aid the European Commission’s (EC) deliberations.

FESI directly and indirectly represents approximately 1,800 sports manufacturers through its 12 national associations, its Special Groupings (European Outdoor Group EOG), its retailers and its directly-affiliated member companies. The European sporting goods industry employs over 640,000 citizens in the EU 28 with an approximate annual turnover of 66 billion euros. FESI members include companies such as:adidas-Group, Amer Group, ASICS,Dainese, Diadora, New Balance, Nike, Pentland, PUMA, Salomon, Saucony and Umbro.Our National Federations are located in Austria, Croatia, Czech Republic, Denmark, France, Germany, Greece, Italy, the Netherlands, Spain, Turkey and the United Kingdom.

FESI shares a critical mass of companies with the Apparel and Footwear International RSL Management (AFIRM) Group with a mission to reduce the use and impact of harmful substances in the apparel and footwear supply chain. Therefore in order to avoid doubling the tremendous amount of work and resources spent in responding to the consultation, FESI and its members wish to endorse the input provided by the AFIRM Group as developed below:

Policy Concerns

The Consultation requests a vast amount of highly technical information on a large number of substances potentially used or found as trace contaminants in the manufacturing of textile articles. Never before has the apparel and footwear industry faced a proposal torestrict so many substances in its products at once, while at the same time being given such a short window of opportunity toprovide important feedback. FESI truly appreciates the two month extension granted from the original January 22nd consultation deadline;however, the breadth of the proposal and the EC’s intent to restrict these substances using the REACH Article 68(2) “Fast Track” process severely limits FESI– as well asthe greater industry’s – ability to provide detailed, scientifically-sound information on more than just a few, priority substances. Of greater concern, the Fast Track process forecloses consideration of the true risk these substances may or may not pose in textile articles and whether the socioeconomic impacts of restricting them would outweigh possible safety improvements. In subsequent sections of these comments we discuss specific concerns about application of the Fast Track process, including the potential for this initiative, though well-intentioned, to undermine the well-established reputation and credibility of ECHA, the EC and the standard REACH restriction process under Articles 69 - 73.

  1. The Proposed Restriction Does not Consider Risk and Disregards CEN Recommendations for Establishing Product Chemical Restrictions

After publishing Technical Report TR 16741 in 2015, the European Committee for Standardization (CEN) was mandated by the EC to initiatethe creation of a guide to support technical committees in developingappropriate product standards to minimize the use of hazardous chemicals in products, andtherebyreducehealth and environmental risks arising from chemical exposures. Still in draft form, the “Guide for addressing chemicals in standards for consumer-relevant articles”[1] provides a number of sound recommendations that should be taken into account inthe current proposal. The EC’s intention to move forward with thisproposalwithout due consideration of the CEN Guideis concerning. FESI questions the purpose and wisdom of allocating resources to development of theCEN Guide while concurrentlypressing forward with a comprehensive proposalthat completely disregardssome of its key recommendations. For example, the draft CEN Guide states that:

When developing chemical provisions for consumer-relevant articles it is essential to evaluate the risks to human health and the environment associated withthe exposure to chemicals. This process has been called chemical risk assessment. Within REACH this is designated as chemical safety assessment (CSA) and is linked to the specific requirements of this particular legislation (e.g. tonnage thresholds). However, the CSA basic principles and procedures required for the purpose of REACH are equally valid for the assessment of any chemical produced in any amount and used in any product in any regulatory context. Hence, REACH guidance documents for chemical safety assessment are a useful reference for establishing limit values for articles in standards.[2]

The guide goes on to suggest that “scope of application of any limit may have to be adjusted to specific user groups, exposure situations and/or materials. Where appropriate a more in-depth chemical risk assessment or chemical safety assessment may be required . . . In such cases the assistance of specialists (e.g. toxicologists) may be required.”[3]

Contrary to these recommendations, however, the proposed restrictions (30mg/kg for the category of classified dyes and carcinogenic amines, and 50mg/kg for the category of "Other" substances) appear in many respects to be arbitrary and inappropriate for every substance in every material type and product potentially in scope. It is scientifically and economically inappropriate and unnecessary to apply the same generic restriction, when each substance may have a completely different risk profile as determined by its function in the article, migration rate out of the article, and toxicological effect. Proper and thorough consideration, based on sound scientific reasoning and analysis, is required for each substance by way of a proper REACH chemical safety assessment to ensure restrictions are proportionate to the risk posed. Without this consideration, additional and substantial burdens will be placed on industry to ensure compliance with unnecessary restrictions that offer little or no improvement to consumer safety or environmental protection. Conversely, where restriction of a substance is appropriate based on new information derived from the ongoing REACH evaluation process, arbitrary general limits may not provide adequate protection of consumer health or the environment.

The proposed limits of this consultation are also far more stringent than the CEN Guide’s recommended general limits for CMRs in consumer relevant-articles, which are derived from the Toy Safety Directive, i.e., 1000 mg/kg for Cat 1A & 1B carcinogenic and mutagenic substances and 3000 mg/kg for Cat 1A & 1B substances toxic to reproduction. Even if the EC justifies restriction of CMRs to much lower levels than the general limits established in the Toy Safety Directiveby applying the ALARA (“As Low as Reasonably Achievable”) principle, the CEN Guide is clear that technological feasibility and economic considerations should be taken into account. Utilizing the Fast Track process without appropriate consideration of risk, socioeconomic impact, or feasibilityto implement general limits for textile products not only contravenes the well-established and highly regarded REACH restriction process, it completely disregards the CEN Guide’s recommendations and is simply bad policy.

  1. It is Unnecessary to Consider Restriction of Substances already Regulatedin Consumer Products by the EU

The Textiles Consultation covers 291 substances in three separate lists, one of which is a catch-all for a variety of different chemical classes. A number of the substances which would be covered by the Fast Track procedure under Article 68(2) are already found in Annex XVII of REACH, e.g., phthalates, azo dyes and various heavy metals. It is not necessary to impose further restrictions on these substances when they have already been through the full process of scientific and socio-economic evaluation according to the standard REACH procedure under Articles 69 - 73,and without proper consideration of whether there is new scientific evidence to suggest that the scope of the existing restriction is insufficient for the protection of human health and the environment.

  1. The EC should apply the Standard REACH Restriction Procedure under Articles 69 - 73 to CMR 1A and 1B Substances

It is clear that the reduced scientific evaluation and lack of socioeconomic impact assessment present significant challenges to all stakeholders, in particular because the scope of the proposed restriction is so broad, covering nearly 300 substances and encompassing all “Articles that contain a part that consists of at least 80% of textile fibers by weight.” This definition covers a wide array of products across multiple industries and is inconsistent with the idea that this should be a “first test-case” of the Simplified Procedure. As such, FESI requests that the European Commission utilize its discretion to continue with the effective and highly regarded application of the standard REACH restriction procedure under Articles 69 - 73 for CMR 1A and 1B Substances. This includes all incremental steps such as Annex XV Dossier creation, RAC and SEAC assessments, and the Forum of Exchange consultation. Departing from this tested and effective process risks undermining the credibility and reputation that ECHA, the EC, and the REACH restriction process itselfhave gained after several successful consultations in which industry stakeholders were given ample opportunity to provide detailed and scientifically sound feedback on risk and socioeconomic impact for full consideration. Prior restrictions developed from application of the standard REACH processresulted inpragmatic limits and implementation timelines that enabled the apparel and footwear industry to take necessary steps towards ensuring compliance acrossthe value chain. This includes development of validated and harmonized test methods to accurately and reliably detect the presence of restricted substances in products to ensure legal certainty in EU economic operations. It is our desire to see this effective process continue into the future.

  1. The Proposal is Unclear about when the EC thinks the Standard Restriction Procedure will apply

The EC has indicated that for some substances the usual restriction procedure will apply instead, particularly when evidence is received of a certain degree of “complexity” through the Textiles Consultation. However, the EC has said that the criteria for this “complexity” will only be defined once it has received the responses to the Textiles Consultation. Respondents will not be able to provide meaningful input about whether substances should be covered by the Restriction without guidance from the EC as to what constitutes a “complex” case and how the decision to adopt the standard procedure instead will be made. Moreover, as noted in the CARACAL document (CA/102/2014 of 7 November 2014), Article 68(2) does not provide specific guidance for how the Simplified Procedure should be applied to finished articles, resulting in significant uncertainty from industry and other stakeholders about this entire process.

  1. The Proposed Restrictions Will Have Significant Trade Implications

If the proposed restrictions go ahead on such a large number of substances, it will have a significant impact on the global apparel and footwear industry, as well as other textile companies. Manufacturers and suppliers with operations in the EU may be forced to limit the products they sell in the EU temporarily or stop selling some or all of their products entirely. As such, the proposed restrictions will place a huge burden on the industry and create an unnecessary barrier to trade without a properly justified scientific basis to protect human health or the environment.

This raises serious questions about the conformity of the Restrictions with EU obligations pursuant to the World Trade Organization and other international trade agreements. The Restrictions are also not in harmony with the "regulatory" coherence" sought in the ongoing US-EU negotiations of the Transatlantic Trade and Investment Partnership.

Many other countries have implemented national regulatory systems for chemicals which are based on REACH due to its reputation as one of the most respected regimes in the world. The current proposals would call into question the scientific integrity of REACH and the leading position it holds. Further, if the proposed restrictions go ahead, it may encourage other countries to adopt a less rigorous scientific approach when considering the national regulation of potentially hazardous substances. This not only threatens the integrity of REACH, it could also lead to other technical barriers to trade being faced by apparel and footwear manufacturers elsewhere in the world.

Comments on Specific Chemicals

As globally responsible and leading companies in our industry-sector, we welcome efforts toimprove consumer and environmental protection that are science and risk-based with pragmatic implementation timelines. This philosophy is core to our global programs and initiatives. An important example of this approach to continuous improvement, taken by FESI members, is the implementation of robust manufacturing control programs to manage priority chemicals through Restricted Substance Lists. For successful implementation, these efforts need to be based on robust sound science, and cover all related socio-economic aspects relevant for the EU community.

Given the limited timeframe granted for consultation, FESI can offer detailed information and recommendations on priority CMR 1A and 1B substances for which control measures have already been taken by leading brands, as a matter of best practice or in response to existing global legislation, and on several other CMR 1A and 1B substancesthat we believe will aid in the EC’s deliberations. Included in the formatted table requested by the consultation are a number of substances that FESI believes should be considered for regulation using the standard REACH restriction process.

[1] Draft CEN Guide XX:2017: “Guide for addressing chemicals in standards for consumer-relevant articles — Part 1: Guide”

[2]Ibid., 14.

[3]Ibid., 14.