Some consultants are exploiting gaps in the EU Regulation on the joint submission of data and data sharing for REACH registrations, according to law firm Mayer Brown. Writing in this months Global Business Briefing, the firm’s Jean-Philippe Montfort and Thomas Delille warn that some consultants, seeking to sell low cost access to EU registration to their clients, are challenging “essential elements” of the implementing Regulation. In particular, these consultants are taking advantage of lead registrants’ obligation to share available data and respond to a request for it, they say. “Potential registrants or their consultants,” say the lawyers, “are using their right to request an itemisation and justification of the data, as a means to contest [fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][registration] costs and push lead registrants into a corner.” Because of this, discussions between registrants are “getting more difficult”. The Regulation requires ECHA to ensure the “one substance, one registration” principle is upheld, even when a new registrant fully opts out of the joint submission of data. “This is causing problems, with some companies and consultants not only refusing to pay their share of the costs (normally achieved by obtaining a letter of access), but also requesting the key to the registration dossier, known as a token,” they say. Companies justify their request on the basis they will otherwise opt out from all endpoints, where information has been jointly submitted by existing registrants, and have the pretext of a disagreement on the information and/or its cost. If ECHA receives a complaint, this can turn into a joint submission dispute. In such cases, the agency asks the parties to show they have made every effort to reach an agreement on access to the joint submission. If the potential registrant has done this, the agency will probably grant them the access the lead registrant is refusing. The lawyers say this is a “very dangerous development”. It is particularly so when the prospective registrant lacks legitimate rights to refer to full study reports. There is no guarantee for the lead registrant that ECHA will verify the new registration. In these situations, the lead registrant would need to appeal or pursue “lengthy and uncertain national proceedings”. Cases where new registrants “copy and paste already submitted information and refer only to published studies through a full opt-out registration, without contributing to the assessment costs, naturally appear unfair to existing registrants,” they say. “This is because those free riders cherry pick the data served to them on a silver plate.” The full article is available at: Global Business Briefing.
Chemical Watch, 23 September 2016 ;http://chemicalwatch.com ;[/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]