Japan Chemical Industry Association
JCIA
The Japan Chemical Industry Association (JCIA) has nearly 180 member companies, with 80 organizations engaged in the manufacturing and handling of chemical products and related services.
ID: 574906315390-52
Lobbying Activity
2 Apr 2024
Japan Chemical Industry Association (JCIA) appreciates the opportunity to provide the following comments in response to the proposal. JCIA respects the ambition of the European Chemicals Strategy for sustainability, which calls for the safe management of chemicals. Although we understand the establishment of a common data platform is one of the most important initiative to realize the concept of "one substance, one assessment", we have much unclarity on the details of the data platform from the draft regulation. But we would like to make some comments, including requests, to ensure that there are no problems in the future operation of the data platform, as a member of the industry responsible for providing data. 1. Article 2: Definitions Definitions of terms may vary depending on the legal context in which they are used. For example, with respect to "substance", the scope of impurities or the methods and requirements to determine the identity of a substance may differ depending on the applications and regulations. In the current situation where the grouping approach is being advanced in REACH and CLP, the identification of "substances" is essential because multiple substances are evaluated as a substance group or multi-constituent substances are evaluated. In addition, there is a definition for nanomaterials set by the European Commission, and in REACH, those are already managed according to that definition and separately from its constituent substances. In some cases, such as carbon black, Multi-Walled Carbon Nanotubes (MWCNT), and Single Wall Carbon Nanotubes (SWCNT), the assessments themselves are different. In order to avoid confusion between these groups of substances and specific forms of substances for assessment and to achieve the "one substance, one assessment" concept, we would like to see particular clarity on the definition of "substance" handled in the data platform, so that there is no confusion among the relevant regulations. If a controlled vocabulary is to be developed, we would like it to see consideration given to ensuring the appropriate assessment of the same substance according to its use and the purpose of the regulation based on the definition of its vocabulary. Furthermore, we would like the polymer identity for the assessment to be consistent with that for registration currently being considered in the REACH revision. 2. Article 3: Data contained in the platform We believe that the scope of information excluded from the common data platform based on paragraph 3(a) and (b) is reasonable in view of the intent of the platform. In the future, when considering the inclusion of information other than the data source proposed here in the platform, we would expect the platform proceed with caution in coordination with industry experts when it relates to information that depends on the properties of products, including composition of substances. 3. Concerns about the use of data collected under different regulations (1) Different regulations have different data generation processes and collection requirements, resulting in differences in the scope and level of data collected. In conducting assessments under each regulation, the data generation process and scope of application should be taken into consideration before use to ensure conformity with the purpose of the regulation. It is presumed that more predictive data will be submitted in the future, and we would appreciate clarification of the assessments for which such data are acceptable. (2) Although the operators have submitted notifications under the respective regulations, it is possible that at the time of notification, they did not anticipate that the data would be used outside of the relevant regulatory authorities. If the data is to be used outside of the relevant regulatory authority in the future, we would like the business operator to be briefed in advance and to have sufficient consent. Although confidential information of business operators s
Read full responseResponse to Revision of EU legislation on hazard classification, labelling and packaging of chemicals
29 Mar 2023
Japan Chemical Industry Association (JCIA) appreciates the opportunity to provide the following comments in response to the proposal of amending CLP regulation. JCIA supports the EU's efforts to strengthen the Chemicals Management under the Chemicals Strategy for Sustainability (CSS). However, the CLP is a regulation that forms the basis of EU chemicals regulations, and its revision will affect not only the businesses in EU but also in other countries that handle chemicals through their supply chains. In order to ensure that this amendment will have the appropriate effect on global business, the concerns of non-EU businesses with respect to this proposal are described below. 1) Addition of new hazard classes (Article 1(4)) As the UN Sub-Committee of Experts on GHS start to discuss whether to introduce the new hazards into the GHS in a proposal by the EU, we ask that the evaluation criteria for CLP also be consistent with those of the GHS. 2) Harmonized classification (Article 1(17)) The scientific and technical criteria for determining the new hazard class are not yet published as stated in page 1 of the proposal. Therefore, we are concerned that it is not feasible to perform a harmonized classification for all ED, PMT/vPvB, and PMT/vPvM in the same way as CMR. For businesses that classifies their products as soon as the Delegated Act enters into force, if the harmonized classification is issued without time from the self-classification and the differences between them are large, a new notification of reasons may be required. In the future, extension of the GRA is also being considered in the REACH revision. We are concerned that the scope of restriction will be automatically extended by becoming subject to the Harmonized Classification, resulting in excessive restrictions on products that are useful to EU society despite their low risk. When they are classified as Cat.1, this will have a ripple effect on the regulation of plant protection products and cosmetics, affecting many industries. The transition period for substance classification in the revised Delegated Act is 24 months, but considering the regulatory impact after classification, a grace period of 48 months or more would be necessary. 3) Obligation to notify Self-classification to ECHA (Article 1(20)) Article 40.1(g), (h) of CLP will be found after the notification of classification made based on the Agreed entries in Article 41. Therefore, they are not considered to be appropriate for the notification items. It is understandable that the C&L inventory should be unified as much as possible, but if, as in the proposed amendment, notifiable classifications other than ANNEX VI must be checked, differences from the self-classification must be clarified, and the reasons for the differences must be reported, it would be burdensome for businesses to check the most severe classification for each substance when multiple registrations have been notified for a single substance, and to provide the reasons for the differences. In addition, the burden on businesses is high for samples for testing and research. Moreover, if, for example, the most severe classification is derived from a trace component due to a difference in the manufacturing process of the substance, it is difficult to explain the reason for the difference between the company's classification and that of other companies, and therefore it is not appropriate to make this an item for notification. Even if a reason is to be reported, we propose that the hazards to be covered be limited to hazard classes of particular concern, such as CMR, and that the comparison of classifications be limited to information on REACH-registered substances. For example, if the reason is that the REACH registrant was unaware of information in an academic article, it may lead to a change in the classification of the registration information. We propose to make the reason for submission a choice rather than a descriptive type (e.g
Read full responseResponse to Introducing new hazard classes–CLP revision
17 Oct 2022
JCIA has repeatedly requested that the new hazard classes be discussed first in the UN GHS. Even if the CLP introduces the new hazard classes prior to the UN GHS, we hope that the impacts on the global supply chain, including products necessary to build a sustainable society in Europe, will be minimized.
On the other hand, we appreciate the EU’s cautious approach in discussing the introduction of neurotoxicity, immunotoxicity, and terrestrial toxicity as new hazard classes in the CLP.
In introducing a new hazard classes, we consider the following with respect to period of application: Since Most of European and global companies generally use a system to make SDSs, we request that consideration be given to updating the system, securing relevant testing institutions to classify EDs, and preventing confusion in the global supply chain. In addition, we request that a time frame be set with due consideration given to the establishment of guidelines and the time when evaluation by testing institutions becomes practically possible. As for the specific deadline for the introduction of hazard classes, we believe it would be helpful to refer to the time when the GHS was introduced. When the GHS was introduced in 2008, there was a 5-year deadline for introduction starting in 2003. Since this new hazard classes are the first hazard identification in the world, we believe that a 5-year introduction deadline should be set for substances. For mixtures, we propose a deadline of 7 years with an additional 2 years in line with the draft regulation.
With the introduction of the new hazard classes, manufacturers, importers and downstream users will be required to collect a large number of evidences, including ED identification. On the other hand, proposed grouping of substances, such as those being considered aim to identification of substances of concern in REACH, may hinder scientific evaluation and may also be a major obstacle in the development of products essential for a sustainable society.
If EU will introduce new hazard classes, we hope that the guidance will be early enhanced to make it easier to understand for businesses inside and outside the EU. The guidance should clearly explain the concerns and questions indicated in the attachment.
When these new hazard classes are introduced into the CLP Regulation, we would like to ask for clarification on how the CLP notification obligation and the database at the ECHA site will be subsequently made in the operation of the law. In addition, we would like to request that the EU market continue to take careful measures in the study of expanding the scope of products covered by the CLP Regulation, which is separately underway in conjunction with the addition of this new hazard class, as the impact on the EU market is expected to be even greater.
About JCIA
The Japan Chemical Industry Association (JCIA), a member of International Council of Chemical Associations (ICCA), represents the major Japanese companies engaged in the chemical business. JCIA member companies supply a wide range of chemical products to most kind of the manufacturing industries and contribute to the development of digitalisation and greening of the world.
Read full responseResponse to Revision of EU legislation on registration, evaluation, authorisation and restriction of chemicals
1 Jun 2021
The Japan Chemical Industry Association (JCIA) welcomes the feedback opportunity regarding Inception Impact Assessment/Revision of CLP. The JCIA supports the noble ambitions of the EU’s Chemicals Strategy for Sustainability (CSS) which aims to improve the EU chemicals policy, including REACH and CLP, for sustainability and competitiveness. The JCIA has a keen interest in the significant changes in REACH and CLP, particularly in terms of international harmonisation and regulatory predictability.
Please find our comments as attached.
Read full responseResponse to Revision of EU legislation on hazard classification, labelling and packaging of chemicals
1 Jun 2021
The Japan Chemical Industry Association (JCIA) welcomes the feedback opportunity regarding Inception Impact Assessment/Revision of CLP.
The JCIA supports the noble ambitions of the EU’s Chemicals Strategy for Sustainability (CSS) which aims to improve the EU chemicals policy, including REACH and CLP, for sustainability and competitiveness. The JCIA has a keen interest in the significant changes in REACH and CLP, particularly in terms of international harmonisation and regulatory predictability.
Read full responseResponse to Amendments of the Annexes to REACH for registration of nanomaterials
6 Nov 2017
Regarding the Definition for Nanomaterial and Nanoforms
1. For nanomaterials, what shall be complied with is described in the amendment proposal, but in practice, the first task is to judge whether it corresponds to nanomaterials. The review and potential revision of the definition for nanomaterial should be finished before this amending an Annex of REACH.
2. REACH regulation does not include the term “nanomaterial” which is very important and should firstly be defined in the text of REACH regulation by quoting Commission Recommendations after the review and potential revision.
3. The present amendment proposal includes the term “nanoform,” wherein Commission Recommendation 2011/696/EU did not. “Guidance note on nanoforms” in Annex VI includes the first explanation for the term “nanoform,” which should be explained to satisfy the requirement in Annex I. Therefore the term “nanoform” should be mentioned in the definition for the term “nanomaterial” in the text of REACH regulation, which describing the details in the Annex or guidance is desirable.
4. Nanomaterials include existing materials without new or enhanced properties derived from nanosize. It has been recognized that those materials are seamlessly maintained under the current framework in REACH. We hope that harmonizing the regulatory management of nanomaterials with other regions will be considered to specify nanomaterials required regulatory management additionally under this amendment of an Annex in REACH by adding “new or enhanced properties derived from nanosize.”
5. We hope that the requirement of information to register on newly added nanomaterials with a low possibility of exposure, for example by compounding to immobilize in a matrix such as resin, will be exempted. Furthermore, as it is difficult to judge whether a mixture containing nanomaterials is subject to this regulation, we request guidance to clarify the judgment criteria for nanomaterials in mixture.
6. Considering registrants who are facing this type of issue for the first time, we would like a longer and gradual grace period set based on the number of tons of nanoform substances.
Regarding the Tonnage
7. Substances with multiple nanoforms may require the registration dossier to be substantially revised. If it is necessary to provide all the requested information for each nanoform (or a set of nanoforms) based on the total tonnage of the substance, there are concerns that the registration fee for that substance will lead to extremely high costs. Because the fee includes the costs of acquiring all of the requested information and the examination fees for all of them, the fee may multiply the number of nanoforms (or sets of nanoforms) registered in the dossier. Evaluations as needed, with a tiered approach by exemplifying ECETOC proposals, for example, are desirable.
8. In Annex III (1–10 tons), we would like to request the phrase “for substances with nanoforms, unless those nanoforms are soluble in biological and environmental media” should be deleted and stay the original text according to Annex III essentially targeting regardless of nano and non-nano substances with hazardous concerns for CMR or disperse or diffuse applications.
Regarding the Test Method
9. We hope that newly added nanoform substances as organic chemicals will be clearly indicated in 7.8 in Annex VII mentioning “7.8. The study does not need to be conducted if the substance is inorganic.”
10. TG211 among aquatic toxicity studies (9.1.1 and 9.1.2 in Annex VII and 9.1.3 in Annex VIII) for aquatic organisms in OECD has been determined to be “applicable to nanomaterials,” wherein TG210, TG202 and TG201 are proposed modification. It is premature to conduct these tests and it is considered to be an item to be added after the test method for evaluating the behavior of nanomaterials in the environment and the aquatic toxicity has been established.
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