Document ybmD0vxp4rMjZVbdZgzJeozBV

JAPAN COSMETIC INDUSTRY ASSOCIATION May 31, 2023 Comments on Proposed Restriction of PFASs Dear Sirs and Madams: Japan Cosmetic Industry Association, JCIA, is representing interest of more than one thousand Japanese cosmetic companies. We would like to express our sincere gratitude to your significant efforts to tackle the emerging issues such as PFASs to protect and preserve the global environment. At the same time, we concern that the proposed restriction of PFAS is an excessive measure because it restricts more than 10,000 of organofluorine compounds (PFASs) on the grouping basis with their persistent nature without risk assessment. We are submitting comments regarding to "1. Inconsistences in the Proposed Restriction" and "2. Exhaustive Grouping of PFAS may Unnecessarily Restrict Chemicals" at the public consultation of ECHA as follows: 1. Inconsistences in the Proposed Restriction (1) Hazard Identification and Characterisation In this restriction proposal, hazard information is not described properly. Both "very persistent" and "concerns associated with their persistent nature" are explained as hazard. However, none of these considerations are recognized as a "hazard" under EU legislation. Also, toxicity data with dose-dependency are missing. The restriction proposal presents significant challenges in this respect from a legal perspective. The proposal shall be based on hazard, exposure and risk assessment, however, the concerned hazard is unclear on this proposal. (2) Exposure Assessment As there is no assessment of the conditions of use for individual PFAS compounds under the current dossier, potential exposure and releases of individual PFAS compounds cannot be estimated. PFASs are defined collectively but are not evaluated individually with respect to their usage. We cannot demonstrate that specific PFAS would in fact be released to the environment without exposure assessment based on usage of individual PFAS compound. (3) Risk Identification The current proposal doesn't follow the requirements imposed to ECHA regarding risk identification. Article 68 of REACH requires the Agency to demonstrate that a risk exists, and that the risk must be controlled at the Community level. In this context, the necessity of risk management should be described. (4) Restriction of PFASs only by persistency is not consistent with principles of the existing regulatory flamework for restriction of substances. There is no substance registered in Annex XVII, which contains 76 entries (as of May 2023), by the reason of persistency only. Substances listed in Annex XVII are restricted under REACH described in the Title VIII as "RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES". As quoted above, general principle of restriction of chemicals under REACH is to restrict chemicals not only based on persistency, but by comprehensive environmental risk assessment. 6TH FL., METRO CITY KAMIYACHO, 1-5, TORANOMON 5-CHOME, MINATO-KU TOKYO, JAPAN 105-0001 TEL: FAX: 1 JAPAN COSMETIC INDUSTRY ASSOCIATION 2. Exhaustive Grouping of PFAS may Unnecessarily Restrict Chemicals The current PFASs Restriction Proposal would restrict numerous PFASs substances that have not been risk-assessed and for which no unacceptable risk has been demonstrated, by grouping all various PFAS substances together and by restricting them as a single class in breach of Article 68(1) REACH. Article 68(1) REACH provides that substance(s) can be restricted only if they pose an unacceptable risk to human health or the environment. This unacceptable risk must be clearly demonstrated by conducting a risk assessment that follows the conditions of Annex XV to REACH (and by cross-reference of Annex I and Annex XIII). Such risk assessment comprises hazard identification and characterisation, exposure assessment and risk characterisation. (1) Short-chain PFASs should be Out of Scope of the Restriction Short-chain PFASs should be out of scope of the restriction because they have lower bioaccumulation. The definition on PFASs of the authorities of five countries is very broad so that it is possible to include a substance which has low or no bioaccumulation. It is appropriate and reasonable to exclude them from the scope. PFASs are theoretically known to be highly persistent, because the carbon-fluorine bonds are one of the strongest chemical bonds in organic chemistry. Experimental data have shown some of them are highly persistent in water/soil/sediment or any other relevant environment. However, the chemical structure of PFASs is widely diverse and that may lead widely diverse of physiochemical or hazardous characteristic property of PFASs. In fact, it has been reported that some PFASs have different physicochemical properties such as water solubility depending on the chain length, and as a result, have different bioaccumulation potential. The following statements can be found in the report on perfluoroalkyl substances by The Agency for Toxic Substances and Disease Registry (ATSDR) land UNEP2. short-chain species have relatively good solubility in water and alcohol.' The bioaccumulation potential of perfluoroalkyls is reported to increase with increasing chain length.1 The short-chain substances are not as bioaccumulative as the longer-chain substances such as PFOA and PFOS. 1 PFAAs (perfluoroalkyl acids) with shorter chain are in general less bioaccumulative. 2 (2) Appropriate Exposure Assessment and Risk Identification Based on Usage and Properties are indispensable PFASs are used in various industrial sectors. It is essential to design exposure scenarios for each PFAS used in different applications and to conduct exposure assessments according to their properties. This leads to proper identification and management of risks to achieve circular economy and minimizing chemical pollutions. We would really appreciate if you could consider our comments. 1. Toxicological Profile for Perfluoroalkyls Draft for Public Comment, June 2018, The Agency for Toxic Substances and Disease Registry (ATSDR) https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf 2. Report of the Persistent Organic Pollutants Review Committee on the work of its fifteenth meeting, p.15, October 2019, UNEP. http://www.pops.int/TheConvention/POPsReviewCommittee/Recommendations/tabid/2 43/ctI/Download/mid/18045/Default.aspx?id=53&ObjID=27348 6TH FL., METRO CITY KAMIYACHO, 1-5, TORANOMON 5-CHOME, MINATO-KU TOKYO, JAPAN 105-0001 TEL: FAX: 2 JAPAN COSMETIC INDUSTRY ASSOCIATION <Related Articles> 1) Conditions of Restrictions under REACH Article 68(1) of REACH describe as follows: There must be an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which Must need to be addressed on a Community-wide basis Additionally, any decision to restrict must take into account the socio-economic impact of the restriction, including the availability of alternatives Articles 69 to 73 of REACH describe the process for the adoption of restrictions by means of amendments to Annex XVII to REACH. 2) Regulations for "Restricted Proposal" in REACH Annex XV to REACH lays down the requirements applicable to a dossier, referring to the relevant parts of Annex I to REACH, as applicable, for the methodology and format. Section 3, Part II of Annex XV specifies that: "The risks to be addressed with the restriction shall be described based on an assessment of the hazard and risks according to the relevant parts of Annex I and shall be documented in the format set out in Part B of that Annex for the Chemical Safety Report." 6TH FL., METRO CITY KAMIYACHO, 1-5, TORANOMON 5-CHOME, MINATO-KU TOKYO, JAPAN 105-0001 TEL: FAX: 3