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Within Reach

2018 may be over two years away, but deadlines have a tendency to sneak up much quicker than anticipated. European companies that manufacture chemical substances – or import them from outside the EU at 1-100 tonnes per year (t/y) – must start implementing, or proceeding with, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.

Understanding and planning the right compliance approach is key to ensuring that international uniform chemical information database (IUCLID) registration dossiers are accepted. But, with the amount of work that goes into these documents, many businesses need assistance, and pharma is turning to CROs that have the experience and tools necessary to complete the process.

Understanding REACH

REACH is an EU regulation and was originally introduced in 2007. It is designed to improve the protection of human health and the environment by identifying the intrinsic properties of chemical substances earlier and more efficiently. It also aims to enhance innovation in, and the competitiveness of, the EU chemicals industry.

However, compliance does not come easy; REACH has often been called one of the most complex chemical regulations in the world. In addition to setting standards for production, import and use of substances, it holds the industry responsible for assessing and managing the risks posed by chemicals, while providing appropriate safety information to end-users.

In the 2014 evaluation report from the European Chemicals Agency, it was found that more than 60% of dossiers failed when checked for compliance. Whether this is due to, for example, incorrect substance identification or the misuse of read-across – using data of structurally similar substances to characterise a different substance – companies can benefit greatly from the assistance of a third-party expert. Those that are poised to take advantage of such help are those that develop or import pharmaceutical intermediates.

Determining Intermediate Status

Intermediates under REACH are defined as substances that are manufactured for, and consumed in or used for, chemical processing, in order to be transformed into another substance. These have to be registered unless they are non-isolated – meaning that, during synthesis, they are not intentionally removed from the equipment in which this process takes place. Although isolated intermediates do have to be registered, this can be completed under a different regime when certain conditions are met.

When registering intermediates, if the producer or importer can prove that the product has been manufactured and used under strictly controlled conditions (SCC), considerably less safety data is required, in comparison to that needed for a standard substance. The registrant will indicate on the dossier that they have the necessary written confirmations in-house from all downstream users of the substance.

SCC standards require, for example, that an intermediate is rigorously contained by technical means during its whole lifecycle; is handled by trained personnel; and that special procedures are put in place for its cleaning and maintenance. Producers and importers of intermediates will also have to confirm that all downstream users are exercising SCC. In filling out dossiers correctly, it is important to fully understand where products fall within these requirements – for instance, whether SCC applies during manufacture and use throughout the entire supply chain.

Selecting an Approach

To ensure REACH compliance is met efficiently and with limited cost, organisations need to develop their programme as soon as possible; planning ahead will guarantee that regular business is not interrupted.

Before the process even begins, pharma companies need to determine whether or not they are going to complete registration in-house or outsource it to a CRO. Currently, global capacity for both REACH expertise and testing is limited, and while several chemical and pharma firms have already begun looking at accessing and securing the required capacity, others are still waiting – risking being unable to meet the deadline. In addition, stalling proceedings could lead to a sudden avalanche of required work, as well as strong competition as businesses fight for CROs.

In taking a conventional approach to the REACH regulation, pharma companies must first fully understand their own business portfolio. A quick assessment of the substances they produce or import will determine which are subject to REACH, and what steps must be taken to comply. After identifying the intermediate status of pharmaceutical substances, an organisation will then need to complete a data gap analysis to decipher what testing is required. Ultimately, all of the information – such as substance identity (composition and analytical data), identified uses and production volumes – will be used to prepare the registration dossier for submission.

If a pharma company chooses to outsource the work, it will usually need to put out a request for proposal and collect bids from potential partners. After examining their options and identifying a collaborator, businesses are left hoping that the CRO laboratory they choose meets the REACH deadline, and that they are not hit with unexpected costs outside of their budget.

Experienced Partners

Fortunately, there are CROs that have already created comprehensive solutions for the REACH pharmaceutical intermediates standards. Armed with knowledge and experience, a CRO can complete analysis, testing and dossier submission quickly and cost-effectively, while also minimising the number of supply and communication channels. It is advisable to take a ten-step approach, which should help every registrant successfully complete the registration process.

When working specifically with intermediates, the CRO can check whether the substances fulfil all of the requirements as defined by REACH, before registering them under a different regime (as an intermediate manufactured and used under SCC). However, often the requirements are not entirely fulfilled, and the product will need to be registered under the standard regime and regular testing will have to be carried out. If this is the case, a CRO can aid the business in moving forward with the appropriate action.

Experienced CRO partners will be fully transparent and help plan budgets leading up to 2018. A clear strategy should be based on each company’s own deadlines, starting with the due date and working backwards. Part of the package should include constant status reports and full control over the process. In addition to guaranteed capacity for the duration of the scheme, pharma firms will have the potential to add substances or supplementary tests throughout the duration of work.

Why Wait?

Implementing a REACH programme with a CRO will give companies access to a number of key participants. The main point of contact and coordinator will be a project manager that owns, schedules and records the regulation process, to ensure timelines and expectations are met. This person will also monitor the studies and provide regular updates, monitoring key areas, such as regulatory affairs, planning, scientific decisions and finance. All operations should include a clear process for quality and service feedback to ensure optimum performance throughout the lifetime of the agreement.

Pharma would be best advised to not leave preparation for the 2018 REACH deadline to the last minute. If assistance with any part of the process is required, enlisting the aid of an experienced CRO will provide peace of mind and assurance for accurate and efficient substance registration.

Box 1: REACH Outlined

The REACH regulation was introduced in 2007, with phased implementation up to 2018. Under the legislation, in order to produce and market chemicals in the EU, companies must demonstrate their substance’s safety to the European Chemicals Agency, and outline the required risk management measures to the downstream user (including the consumer). REACH defines certain procedures for the collection and analysis of data on hazards, and – if these are deemed unmanageable by authorities – the product’s use may be restricted, or even banned. Its guidelines apply to all chemical substances, so could affect most European businesses across a wide range of sectors.

Box 2: Ten Steps to Registration

1. Inventory – includes the identification of substances, tonnage information, use mapping, collection of in-house data and checking of intermediate status
2. Late pre-registration – late registrants will have to complete a data quality check and submit an IUCLID
3. Refinement of inventory – all Substance Information Exchange Forum data will be gathered and a literature search conducted
4. Data evaluation – the preparation of summaries, hazard assessments, and classification and labelling. For intermediates, preparation of the required documents (followed by step 9)
5. Determination of data gaps – a preliminary overview of data gaps in the dossier
6. Completion of data requirements (Annex VII/VIII) – read-across and quantitative structure activity relationships will be used to fill in gaps; animal testing is a last resort
7. Chemical safety assessment/report – classified substances (>10t/y) require labelling (for example, corrosive) and need to complete a lifecycle analysis, an exposure assessment, risk characterisation, determination of risk management measures and risk scenario building
8. Preparing a test proposal – testing is needed for substances exceeding 100t/y that have data gaps
9. Dossier preparation, finalisation and submission – all collected data will be brought together in the IUCLID, and the dossier is created
10. Safety data sheet – an extended safety data sheet is required for classified substances

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Jeannette Paulussen is Head of Regulatory Affairs at WIL Research, and has worked in similar roles across the CRO industry – both in the Netherlands and the UK – since 1997. She joined WIL Research in June 2010 as a Senior Regulatory Affairs Manager, responsible for consultancy on REACH, associated dossiers, chemical safety assessment for human health and project coordination. Jeannette has a PhD in Pharmacy.
Jeannette Paulussen
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