REACHModus 1 - The "Planning" Phase
REACHModus 1 includes assessing and planning for the impacts of REACH to a particular organisation. It is focused on meeting the 01 December 2008 deadline for substance pre-registration with the European Chemical Agency (ECHA).
The modules within REACHModus 1 include the following.
| Scoping | REACH affects each business differently. Scoping is a critical step to ensure that a company addresses the correct issues and focuses their resources on the most critical items. Scoping also includes a Legal Entity Review in order to identify if an organisation has multiple legal entities that need to register substances separately. |
| Training and Awareness | H2 Compliance can fill the training and awareness gaps that may be present within an organistion. This is an optional step as some organisations are up-to-speed on REACH. |
| Project Planning and Management | From the outset, REACHModus creates a time and resource schedule and a project plan in order to map out the inputs, activities and outputs for successful project implementation. |
| IT Requirements Review | IT systems vary from business to business. H2 Compliance has therefore searched the IT solutions market on behalf of our clients in order to provide them with the most up-to-date software to handle substance data and manage communications in the supply chain. H2 Compliance will work with the organisation to ensure that the best solution, whether outsourced or in-house, is efficient and meets the on-going needs of REACH. A common misconception is that the effort required for REACH ends when the substances are registered; this is untrue. REACH is an on-going requirement - changes in use, exposures and classification will need to be managed on a regular basis; therefore it is paramount that a strong IT solution is selected from the outset. |
| Substance Inventory Assessment | The assembly and analysis of an organisation's substance inventory is not an easy task. Data on substances can be stored in different locations within an organisation and can be difficult to track down. Assembly of this data will also be dependent on the IT solution that has been selected. H2 Compliance will guide the client with the assembly of the data, but will mostly focus on inventory analysis which is a critical step to identifying which substances require registration, and equally, which substances are critical to your production process. The criticality of these substances and supply chain issues are addressed in the Business Impact Analysis module. |
| Supply Chain Communication | The supply chain impacts of REACH are of serious concern and must be addressed via effective supply chain communication. H2 Compliance's involvement in this process can be specified to the client's needs. It is a resource-heavy activity and can therefore be handled in full or in part by H2 Compliance. |
| Business Impact Analysis and Mitigation | Downstream users of substances are the hidden victims of REACH. If an business's suppliers are not willing to register a substance that is critical for an organisation's production process then it can have serious consequences on your business. Legally, if substances are not pre-registered by 01 December 2008, they will not be allowed to be used or placed on the market until a registration dossier is submitted for that substance. |
| Similar Substance Identification - QSAR | A requirement of pre-registration is to establish the correct identity of substances in order to enable effective grouping of SIEF's. This is a process also known as Quantitative Structure-Activity Relationship (QSAR). QSAR is the process by which chemical structure is quantitatively correlated with a well defined process, such as biological activity or chemical reactivity. The basic assumption is that similar molecules have similar activities. |
| IUCLID 5 Training | Once your inventory has been analysed it is time to prepare for pre-registration. Substance pre-registration data is submitted to ECHA via the IUCLID 5 software programme. It is vitally important that the client is familiar with the structure and function of IUCLID 5 in order to manage legal entities and correctly submit pre-registration data |
| Submisison of Pre-registration Data | The task of submitting pre-registration data is staightforward, as long as the previous steps have been completed successfully. Pre-registration involves entering the required pre-registration data into the IUCLID 5 software and submitting it to ECHA. The required pre-registration data includes the name of the substance, its EINECS and CAS number, name and address of the registrant, envisaged deadline for the registration and the tonnage band. |
| SIEF Planning and Roadmap | After pre-registration takes place, the ECHA will assemble all of the pre-registation and QSAR data and notify registrants of the Substance Information Exchange Fora that they belong to. H2 Compliance will assist the client to project manage future registration deadlines and provide advice on SIEF activities and the protection of confidential business information. This module feeds logically into REACHModus 2, which addresses the management of SIEF activities. |