12 June Room 0B Centre Albert Borschette Rue Froissart Brussels, Belgium

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1 EUROPEAN COMMISSION ENVIRONMENT DIRECTORATE GENERAL Circular Economy and Green Growth Sustainable Chemicals DIRECTORATE GENERAL INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMES Consumer, Environmental and Health Technologies REACH Chemicals Brussels, 04/06/2018 Doc. CA/46/ th Meeting of Competent Authorities for REACH and CLP (CARACAL) Open Session 12 June 2018 Room 0B Centre Albert Borschette Rue Froissart Brussels, Belgium Concerns: Implementation of CLP Annex VIII Agenda Point: 7 Actions Requested: For discussion Written comments can be sent by 11 July 2018 to: GROW CARACAL@ec.europa.eu, ENV CARACAL@ec.europa.eu, An.Jamers@ec.europa.eu, Fabienne.van Raemdonck@ec.europa.eu 1

2 IMPLEMENTATION OF CLP ANNEX VIII Background 1. Notification portal Pursuant to Annex VIII of CLP, importers and downstream users shall submit information in a harmonised format on chemical mixtures classified as hazardous on the basis of their health or physical effects to the appointed bodies, for every Member State (hereinafter 'MS') in which the mixture is placed on the market. It lies in the discretion of the MS, however, to define the tools and specific modalities for submission. Upon industry s request, supported by a large number of Member States, the Commission considered options for the setup of a notification portal at EU level. The portal to be developed and maintained by ECHA could have different functionalities, ranging from a basic dispatch mechanism to a database permanently accessible by national appointed bodies. While a basic dispatch mechanism would mainly alleviate the administrative burden for industry, an accessible database could in addition create efficiency gains for MS as they could to a large extent rely on ECHA's resources for the management of the submitted data. During the ECHA Management Board meeting in December 2017, it was decided that ECHA will develop the portal with the dispatch function. As concerns the searchable database, the Management Board indicated that ECHA will be ready to develop this depending on the availability of the necessary financing and resources. Dispatch function The work to develop the central notification portal was kicked off by ECHA in in January 2018 with a focus on the first basic version with dispatching functionalities. The workflows and processes required to make availablethe notifications to the national bodies in a secure way are currently being analysed. This includes the user management mechanism for appointed bodies to sign up and authenticate their credentials in order to access and download those notifications. As a side note, other functionalities to be included in the first basic version, relevant for industry users, are the preparation, validation and submission of a notification online, tracking of the submission status and viewing of the outcome. Searchable database Concerning the development of the searchable database, the Commission has verified the possibilities for additional financing through the EU subsidy or ECHA fee income (from 2

3 regulatory processes other than the notification obligation under Art. 45 of CLP, as for notifications no fees will be levied at EU level). For this, the Commission together with ECHA have set up a clear and detailed plan on the different functionalities of the searchable database, as well as related financing and staff needs. Based on the outcome of these actions, the Commission services drafted a Commission Implementing Decision, re iterating the legal basis and including a financial fiche on the resources for the years to come, requesting ECHA to develop the searchable database. The draft Decision will be presented to the REACH Committee of 13 June. The vote is expected to be taken during the July REACH Committee meeting. Upon a positive vote, the request will be forwarded to ECHA, where the Management Board will decide on the development of the searchable database. Work on the development of the searchable database could be initiated in summer 2018 with the aim of making it available by November 2019 together with the deployment of version 2 of the portal. 2. Guidance on the implementation of Annex VIII to CLP The ECHA guidance document on the implementation of Annex VIII to CLP was following the usual procedure for drafting and adoption of ECHA guidance documents presented to and discussed with the Partner Expert Group (PEG) on 23 and 24 May. MS competent authorities, appointed bodies, poison centres and industry representatives attended the meeting. For some issues, further consultation with CARACAL was considered desirable (notably the location of the UFI on the label and the requirement to list the UFI in the SDS, as discussed further in this paper). The draft guidance was amended according to the comments received and agreements reached during the PEG meeting. The next step is consultation of the Forum on the guidance, and subsequently CARACAL. The final version is foreseen to be published on ECHA's website by the end of Workability study status update Background During the discussions on the proposal for Annex VIII to CLP potential workability issues were raised at a very late stage of the adoption procedure by the petroleum, construction products and industrial gases sector among others. Given the time constraints, it was agreed in the REACH committee to nevertheless vote on the proposal. The Commission, on the other 3

4 The study hand, committed to studying those workability issues before the date of application of the Regulation. The objectives of the workability study are (i) to analyse the workability of certain provisions of Annex VIII to CLP in relation to certain industries with complex material inputs and supply chains and (ii) to investigate and propose options to address the workability issues raised by some stakeholders if they are confirmed, and if they can be addressed without losing necessary information for appointed bodies to perform their duties in accordance with Article 45 of the CLP Regulation. Current status and next steps The first call for tender, launched by the Commission and closed on 21 September, did not result in any offers. The Commission launched another call under a different procedure, the deadline for which expired early February Through the Commission's evaluation process a suitable contractor was identified. The contract is expected to be signed any day now so the work can start. MS and observers who have expressed interest in being part of the advisory panel to the study will be contacted in due time for a first meeting with the Commission and the contractor. 4. Actors in the supply chain and related obligations According to Art. 45(1) of CLP legal obligations regarding information submission to appointed bodies are on importers and downstream users. Concerns were raised by Member States and poison centres regarding the potential loss of information in cases where a distributor purchases a product in MS A and places it on the market in MS B. Given the fact that distributors do not have any legal obligations under Art. 45 or Annex VIII, no submission would be done in MS B and information would therefore not be available in that MS in case of an emergency. Moreover, if a mixture was placed on the market under a different brand name in the same MS, the mixture could only be identified via the UFI and not via the brand name. A discussion on the status of re branders and re labellers in particular under Annex VIII to CLP was held at the CARACAL meeting of March 2018, and a solution to overcome the abovementioned issues was proposed. Below, an overview is given of the comments received pursuant to that meeting. The Commission services are currently discussing the matter internally and will present the result of the internal discussions at the November CARACAL meeting. 4

5 SUMMARY OF COMMENTS DE Also actors placing a mixture on the market under a different trade name or manufacturer's name should be duty holders; For DE, the legal wording of the CLP Regula on is clear in providing that whoever re brands a mixture with an own brand name is a DU and falls within the concept of DU under Ar cle 2 (19) of CLP; The concept of 'use' defined under Ar cle 2 (25) of CLP includes the wording 'any other u lisa on' and re branding would fall under this concept; The defini on of distributor under CLP is very narrow, and merely states about 'who only stores and places on the market'; this would be another indicator that re branding ac vi es fall under the defini on of DU and not of distributor; DE refers to the discussion of the REACH Commi ee when adop ng Annex VIII, when DE specified that the duty holders should be defined more specifically; at the me, COM had replied that this was not necessary, given that the concept of DU could be interpreted widely; it appears that COM is now changing its opinion and the reasons given are not convincing; COM argumenta on to ensure consistency between the different regula ons (REACH, CLP) and the guidance documents is not convincing. The reference in guidance to re branders does not exclude the possibility to adopt a different legal interpreta on stemming from the law itself. The actors who use their own manufacturer's or brand name take over the ownership of the mixture and thus they assume responsibility for it themselves (at least as regards product informa on and the product name) thus, these actors should also be duty holders for the obliga ons provided in Annex VIII; 5

6 COM interpreta on on distributors presented at March CARACAL mee ng is impossible to implement and may hardly be jus fied from a legal point of view; conversely to what has been argued by COM, the wording 'for third par es' would rather lead to the conclusion that if actors labelled their mixture with their own name, they would not act for a third party and thus be responsible; COM's interpreta on is impossible to implement in prac ce: the last DU will not have informa on of the further downstream supply chain. DK DK sees a problem in COM's interpreta on that re branders/re labellers are defined as distributors. A lot of useful informa on would get lost; instead, as suggested by BE, re branders should be considered DU who place a mixture on the market on their own behalf; REACH Guidance on Downstream Users should be corrected and state that re branders are DU; At the same me, the roles in the guidance and both the REACH and CLP Regula on should be consistent an analysis should be carried out to assess possible consequences for the qualifica on of re branders as DU; Moreover, further clarifica on of the differences between the concepts of re brander and re labeller may be needed: e.g. if a re labeller merely translates the hazard informa on into the relevant language without changing the label elements then a re labeller could qualify as a distributor ES The fact that re branders qualify as distributors may have a nega ve impact on the availability of quick and reliable product informa on; There are references in Annex VIII which would lead to the conclusion that re labellers and re branders are duty holders (for the re brander: Sec on 1.1, Part B states about the 'brand name'; for the re labeller: Sec on 1.2, Part B states about 'company data as displayed on the label'); It might be difficult to provide adequate emergency health response in those cases where the UFI of a product does not match with the trade/brand name or with the company data; Given that re branders/re labellers are to be considered as 'poisoning agents' (they place the mixtures on the market), ES is highly concerned about the result of having contractual arrangements between the duty holders and the 'poisoning agents'; ES realises that REACH guidance did not consider the role of actors under Annex VIII but it may be necessary that these actors play different roles for the purposes of Annex VIII. IE It is very difficult to align the distributor defini on pursuant to Ar cle 2(20) of CLP to the ac vi es carried out by re branders the la er do not simply store and place the mixture on the market for a third party but they act on their own behalf; Excluding re branders from the DU's defini on would imply the loss of relevant informa on; 6

7 The sugges on that the UFI would enable the iden fica on of a mixture even without a specific submission indica ng the brand/product assumes the following: e original submi er made the necessary submission to the MSs (this is not the case if the product is distributed in another MSs than the MSs of submission by the original submi er); he re brander has not generated a new UFI; More, the most common iden fier of a mixture is the product name/brand name and not the UFI appointed bodies will at first look at the name and only then at the UFI. HU HU shares concerns of other MSs that informa on is lost when distributors place their products on the market in different MSs and when the supplied products are re labelled/re branded; HU does not support COM's interpreta on on distributors; distributors do not act on behalf of their suppliers and are themselves responsible; COM interpreta on might be difficult to implement and enforce from a prac cal point of view. LT Obliga ons of re labellers and re branders should be made clear; LT notes that at the moment re labellers and re branders are not legally obliged to submit, because they are distributors; For the sake of completeness of informa on submission and the preven on of informa on loss, LT proposes to change the REACH Guidance for downstream users as concerns re labellers and re branders; The reference to 'any other u lisa on' under the use defini on of CLP could be interpreted as including re labellers and re branders; The decision that re labellers and re branders need to communicate with upstream suppliers and inform them about new brand changes or other MSs where they place mixtures on the market is appropriate. In this case it could be difficult to ensure submission of correct informa on because it will depend on agreements between the duty holders; It would be good to have a possibility to see no fica ons to other MSs, as such informa on could be useful if poisoning with mixtures bought in other MSs would occur, provided that the confiden ality issues are solved. SE Responsibili es of re branders are unclear and clarifica on is necessary; 1 BE proposal on re branders needs to be further discussed; SE does not agree with the conclusion by the COM on the defini on of re brander; there is no legal requirement for distributors to inform their upstream suppliers; 1 Reference made to the BE proposal is the following BE position paper CA/MS/09/2018: 2dbd 4367 aac1 d33a9d53eea0/17%20 %20CA_ MS_09_Impl_Annex_VIII_CLP_Actors_supply_chain_related_obligations.docx 7

8 Need for short term solu on in the guidance on Annex VIII; a sustainable solu on can only be achieved through a legal amendment. UEAPME UEAPME agrees with the COM interpreta on on re branders; Re branding is not legally defined and re branding and re labelling are not considered 'use'. FECC FECC agrees with COM interpreta on and fully supports it. 5. Requirement to place UFI on the label The Commission has received requests from industry on several occasions to allow printing of the UFI on the packaging instead of on the label. The main argument mentioned relates to the costs associated with the high number of expected label updates as a result of UFI updates. The Commission has understanding for industry's concerns; in addition, it can be questioned whether, from an emergency health response perspective the placement of the UFI on the packaging may have a negative impact on the speed or quality of the health response. From a legal point of view, however, Annex VIII is clear on the obligations: following Part A, section 5.2. the submitter 'shall print or affix the UFI on the label of the hazardous mixture'. Looking at the CLP operative provisions, Art. 32(4) read in conjunction with Art. 31(5) allows placement of the supplemental labelling information outside the label as long as it is located 'with' the other label elements in Art. 17(1)(a) to (g). An amendment of Annex VIII, removing the specification where the UFI should be located, could therefore allow for the flexibility requested by duty holders. Art. 31(5): A label shall not be required when the label elements referred to in Article 17(1) are shown clearly on the packaging itself. In such cases, the requirements of this Chapter applicable to a label shall be applied to the information shown on the packaging. Art. 32(4): The supplemental information shall be placed in the supplemental information section referred to in Article 25, and shall be located with the other label elements specified in Article 17(1)(a) to (g). The Commission invites CARACAL members and observers to provide feedback as to what their position is with regard to (i) allowing for the flexibility to place the UFI also on the packaging (albeit within the legal constraints dictated by CLP Art. 32(4), i.e. the UFI should be located with the default labelling information) and (ii) whether that would necessitate an 8

9 amendment of Annex VIII. It should be noted that this amendment would be independent and separate from any possible amendment resulting from the workability study. 6. Requirement to place UFI in the Safety Data Sheet Annex II to REACH, section 2.2 specifies the following with regard to the compilation of Safety Data Sheets (SDS): 'The applicable label elements in accordance with Article 25 and Article 32(6) of Regulation (EC) No 1272/2008 shall be provided'. Since the Unique Formula Identifier (UFI) is part of the supplemental labelling information (following Art. 1 of Regulation (EU) No 2017/542) it is also to be included in the SDS. As a consequence, every time the UFI changes, the SDS needs to be updated. Given that in the case of packaged products, the UFI will be available on the label/packaging it can be questioned to what extent the UFI is still required in the SDS. In contrast, in the case of unpackaged products or products for industrial use only where the explicit decision is taken to list the UFI only in the SDS and not on the label/packaging (following Annex VIII, Part A, section 5.3.) there is a clear need for inclusion of the UFI in the SDS. In that case, an update of the SDS is needed without undue delay in the case of a UFI change. In order to maintain the balance between information provision on the one hand and avoidance of unnecessary administrative burden in the form of SDS updates on the other the Commission sees merit in the following approach: (i) exempt the UFI from having to be listed in the SDS for mixtures where the UFI is given on the label/packaging; (ii) where no UFI is available on the product label/packaging itself (in the case of unpackaged products or where the choice is made not to provide the UFI on the label of industrial mixtures), the UFI needs to be listed in the SDS. In that case, the SDS needs to be updated without undue delay whenever the UFI changes. For this approach to apply, the necessary provisions would need to be foreseen in Annex II to REACH, which is currently in the process of being amended. A corresponding change in Annex VIII to CLP would likely also be required. The Commission invites CARACAL members and observers to provide feedback as to what their position is with regard to (i) the approach proposed above and (ii) a possible amendment of Annex VIII. It should be noted that this amendment would be independent and separate from any possible amendment resulting from the workability study. 9

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