Practical guide for SME managers and REACH coordinators : How to fulfil your information requirements at tonnages 1-10 and 10-100 tonnes per year : version 1.0 July 2016

This Practical Guide is intended for people responsible for gathering all information needed to compile a technical dossier for a substance to be registered under the REACH Regulation. It is not an exhaustive guidance for experts or consultants, but it is aimed at business managers or REACH coordinators, mainly in small and medium-sized enterprises (status of SMEs). This Guide is on information requirements, i.e. on what information is needed in the registration dossier. It will focus on the following aspects for each required element: - What is it/what does it mean? - Why is it relevant/what is influenced by it? - When is it needed? o Not all elements are needed in every dossier. - Who can do it? o Many elements require an expert to gather and evaluate the information to draw conclusions, but some elements may be done by non-experts. - How can the information be gathered? o A brief indication of relevant methods with links to further information. - How much time does it take? o Some information needs to be created, e.g. through a test; this can take substantial time. For many activities in the preparation of a registration dossier, you will need expert help. To show the level of expertise needed for specific activities, a colour coding scheme is used in this Guide. If only administrative expertise is needed, i.e. if you do not have to be an expert in a specific scientific field, this will be indicated by the words administrative expertise. The words scientific expertise indicate that a certain level of scientific expertise in the relevant field is needed. A junior scientist with relatively limited experience should be able to do this activity. In cases where you need an experienced, more senior scientist to do an activity properly, this is indicated by the words advanced scientific expertise. Generally, if you are an SME, the (advanced) scientific expertise may need to be hired from outside, e.g. from a contract research organisation or a consultant