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Päivi Jokiniemi and Paul Trouth
Article related to: REACH
REACH 2018: how to meet your information requirements
ECHA Newsletter interviewed Dr René Hunziker from Dow Europe GmbH to gain an insight into how Dow is gathering information to fulfil the legal requirements for the substances they are preparing to register in 2018. His message is: start now, plan your testing strategy and use the available support to help you.
Meeting the information requirements on a substance can be a lengthy process with many things to think about. "First, get started straight away," Dr Hunziker, Product Sustainability Leader at Dow says.
Dow staff are already actively preparing and planning their REACH registrations. "Our first step was to collect all available analytical data and then start generating additional data where necessary. Following that, we collected all hazard-testing information on products and developed a draft test plan. Once the identity of the substances has been confirmed, we will reach out to the substance information exchange fora (SIEFs) to check for any additional information and propose any necessary testing," Dr Hunziker explains.
| Dr René Hunziker. |
Challenges and opportunities
A major challenge for Dow is to make sure that the many substances produced by third parties and imported by Dow as co-formulated products or as monomers of polymers in their products are compliant. "As a result, our businesses need to take difficult decisions on whether to rely on the manufacturer for compliance or whether to register the substance ourselves," Dr Hunziker points out.
As some time has passed since pre-registration, it can also prove difficult to determine who is still intending to register a substance that is not currently registered. This makes data generation more difficult as there is first a need to understand what data exists among all the potential registrants.
However, registering in 2018 also brings many opportunities. "A significant number of the substances that we need to register are already registered. The required information is typically available together with a completed hazard assessment," he informs. This makes it easier to collect all the necessary data to meet the information requirements.
Attention should still be paid to validating at an early stage whether your substance really is covered under the existing registration. "Even if this is the case, there may still be uses unique to your company that require further justification on their safe use," Dr Hunziker points out.
Another challenge is forecasting the actual volume of the substances that will be registered for 2018. Depending on the volume, the information requirements may be higher or lower, which in turn affects the time needed for the preparations.
Start preparing now
Dr Hunziker suggests a two-tiered approach to your testing strategy. Firstly, assess whether a reliable prediction can be made using QSAR models. "We are looking at opportunities for QSAR and read-across today because, if at the end we find these inappropriate for a given substance, we still have ample time for standard testing," Dr Hunziker says.
This emphasises the importance of time. "To make best use of the opportunities of an intelligent testing strategy, there needs to be room for failure," Dr Hunziker says. For substances produced between 10 to 100 tonnes a year, Dow plans for a minimum of one and a half years to perform standard testing. In addition, a six to twelve-month waiting period is planned for scheduling laboratory testing. At the end of the testing, Dr Hunziker recommends at least a further six months for completing the hazard assessment and the documentation of safe use where needed. This amounts to almost three years of planning and testing for each substance.
Letter of access
Dr Hunziker explains that in his experience there is very little room to negotiate on a letter of access. "The agreements that are offered have been adopted already by a large group of data holders and cannot be varied for each new registrant. This applies for small and medium-sized enterprises (SMEs) as well as for larger companies".
He highlights the importance of ensuring that the proposed agreement only covers the information required for the tonnage band you need and reminds that the cost sharing should always be fair and transparent.
"We have also started to review the disseminated information for substances where we may need a letter of access. We are doing this to verify that the information for selected endpoints meets our expectations," Dr Hunziker adds.
Using QSAR and read-across
If done properly, the non-animal test methods such as QSAR and read-across can be viable. However, they still represent a significant challenge to both registrants and regulators. "For read-across, we start from a hypothesis and then collect and provide evidence to validate it. The significant opportunity lies in the fact that we can read across to data and studies that are more comprehensive than what is required for the 10-100 tonne a year substances," Dr Hunziker clarifies.
As a helpful source of information, he recommends reading ECHA's illustrative example of a grouping of substances and read-across approach. It gives an outline of the level of information ECHA expects and includes explanations.
Dr Hunziker says that QSAR is a reliable source of information at a reduced cost. "For a series of endpoints, both risk assessment and classification can be covered by QSAR, such as biodegradation or for octanol water partitioning. QSAR methods can also assess all constituents in a substance and provide more confidence in the result on that basis," he adds.
In his department, the QSAR Toolbox is often used. "I am amazed at the amount of scattering in the data when we pull analogues for a reasonably well defined category. The toolbox helps to show whether the scattering reflects the inherent noise of the data, or points to different mechanisms of toxicity that need to be considered in our assessment".
Available support within your reach
ECHA has recently launched a website dedicated to the 2018 registration deadline which Dr Hunziker welcomes. "It offers excellent and essential information in multiple European languages," he describes. ECHA's workshops and events like the upcoming Stakeholders' Day also provide essential information that is recorded and available on the website. "The national helpdesks and their websites are another important source of information, and they are all free of charge," he says.
He goes on to explain that for first-time manufacturers or formulators who can join a registration, the information available in the joint registration will likely be sufficient to help them prepare their own. However, first-time lead registrants should consider establishing a relationship with a competent consultant and with a testing laboratory. "I recommend a consultant independent of the laboratory who can help them through the process – similar to using a site manager in a larger building project who is independent of the building company," he concludes.
Dr Hunziker is the Product Sustainability Leader for Dow's chlorine products business. In this role, he is responsible for the safe use of products and for meeting regulatory requirements globally. He will speak about REACH Information requirements at ECHA's 10th Stakeholders' Day conference on 27 May.
- REACH 2018 web pages
- Information requirements
- Grouping and read-across
- QSAR Toolbox
- What about animal testing?
- ECHA's 10th Stakeholders' Day
- Terminology - in 23 languages
Dow Europe GmbH
Dow Europe GmbH is part of The Dow Chemical Company.
Dow manufactures plastics, chemicals and agricultural products. With a presence in about 160 countries, it employs about 54,000 people worldwide. Dow sells directly to end-users primarily in the human and animal health and consumer products markets.
Interview by Adam Elwan
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