We advise companies in connection with the necessary administrative proceedings, in particular including proceedings at the European Chemicals Agency (ECHA) in Helsinki. That applies in particular to proceedings for the registration or authorisation of substances according to Regulation (EC) No. 1907/2006 (REACH) and likewise for active substances approvals and product authorisations under Regulation (EU) No. 528/2012 (BPR) and comparative parallel regimes (e.g. relating to plant protection products or fertilisers). Cooperation between technical and legal expertise is usually required in this connection. We are very familiar with the legal classification and assessment of demanding chemical-technical or toxicological issues. We are aware from our many years‘ experience that the precisely appropriate shaping of administrative proceedings and corresponding applications is often of strategic significance for the business affected. The extreme importance is illustrated not only by the market and marketing prohibitions threatened by the lack of or inadequate registration, approval or licensing. Market and legal developments to be considered for the future also have decisive influence. And, of course, existing intervention and control powers of the competent authorities must be considered. We advise companies on the structure and conduct of such proceedings and on the defence against additional measures of ECHA (e.g. in the course of substance or dossier evaluation). In addition, we also represent companies before national administrative and criminal investigation authorities (e.g. in proceedings initiated by competent market surveillance authorities). We have long years‘ experience in cooperation with the specialist departments in companies of various industries and their technical advisors. If necessary, we can also avail of our excellent advisor network. And, of course, we represent companies in relevant proceedings before national and European courts and the Board of Appeal of the European Chemicals Agency (ECHA). In doing so, we subject not only the specialist assessment of the relevant authorities but also and in particular the procedural rules to close scrutiny in the interests of the company affected.
Nearly all legislative acts in chemicals regulation demand or permit that companies cooperate and share data and costs in the course of the preparation of required official proceedings. Based on our more than ten years of experience, we have advised companies on the structuring of such data and costs sharing agreements and assisted in negotiations between market players. We also act in the area of subsequent review of costs sharing models and the development and implementation of reimbursement mechanisms. In addition, we also monitor and support the formation of consortia for registrations, authorisations or approvals. We advise companies in connection with questions of accession to consortia and the enforcement of rights in consortia. Of course, we also support the ongoing work within consortia in many cases for example with regard to the consortium management. That includes not only ensuring the necessary competition law compliance but also support in the necessary interaction with authorities at national and European level in applications of the consortium and its members. We also regularly act in proceedings to fine tune regulatory conditions or in drafting official guidelines.
Implementing chemicals and substance law requirements is demanding for companies including in day-to-day business. Compliance with continuously changing regulatory provisions requires flexible and adjustable compliance processes. That applies not only to the interaction with customers and suppliers but also to the organisation of processes in the business. Compliance risks are often lurking at the borders of responsibility between various departments. We advise companies operatively on the structuring and implementation of compliance projects. It is always our aim, in such cases, to take appropriate account of the existing processes and organisational structures and to ensure compliance with regulatory requirements by means of moderate adjustments. We thereby structure the material specification, information acquisition and evaluation, goods inwards control, supplier evaluation and quality assurance processes. Apart from establishing the necessary processes and methods, adequate anchoring in the company by means of corresponding announcements (e.g. by operational instructions and training), appointing responsible persons or teams for individual tasks in the context of compliance processes and the setting up of functioning communication processes between the participants are crucial. We also support companies in specific questions in the operative business. Our work extends from support in answering customer enquiries (e.g. under Art. 33 REACH), through reviewing product labelling (e.g. under CLP or BPR) to answering questions regarding the marketability of products (e.g. having regard to restrictions under REACH). With comprehensive experience gained from dealing with such projects and questions in companies of various industries, we are best equipped to develop tailored solutions within a short time and to support the operative business practice free of friction.
A further building block of our chemicals law advice is supporting and assisting companies and economic and industry associations at national and European level in advance of legislative amendments. We participate in consultation processes in connection with the introduction of new regulatory requirements. That includes advising on statutory amendments e.g. the introduction of new restrictions or approvals according to REACH. Our spectrum of services also includes supporting and framing the development of guidelines of responsible authorities, in particular ECHA. And, of course, we provide support in connection with the ongoing development of entire regulatory areas for example in case of recasts of legislative acts. In that process, we develop meaningful positions in close consultation with companies and/or associations by conducting direct consultative discussions with responsible authorities such as the EU Commission, the ECHA and/or national authorities or participate in decision-making processes within the corresponding committees such as Competent-Authority Meetings or self-constituted working and expert groups, consortia or standardization bodies. We not only undertake in the above connection tasks such as drafting position papers, but rather initiate regulatory assessment of proposed measures in advance and advise on the development of appropriate options for action and lines of argument taking account of the potential procedural developments. We thereby place companies and associations in a position to react at an early stage to pending changes and to develop appropriate implementation or avoidance strategies.