Who can apply for Authorisation?

Manufacturers, importers, Only Representatives (ORs) and downstream users can apply and hold Authorisations for their own uses or for uses down their supply chain. It is important to note that the rules regarding who can be the Authorisation holder may have the potential to cause supply disruptions if there are missing links in the supply chain.

What do I need in order to apply for Authorisation?

The Authorisation application needs to contain an Analysis of Alternatives (AoA), Chemical Safety Report (CSR) and we recommend to also include a Socio-economic Analysis (SEA) with every application. In addition, where appropriate, a Substitution Plan should also be provided to the authorities for their evaluation.

When should I begin to plan to apply for Authorisation?

Authorisation is a time-consuming and highly complex process requiring strategic business thinking. A poorly prepared application runs the risk of not receiving an Authorisation or having a short review period. It also requires the support of a dedicated multi-disciplinary team of experienced experts.

As a result, it is important that companies begin to approach and plan their application early. The preparation of these reports requires a substantial amount of data that may only be available to various different actors in the supply chain. The entire application preparation process, including strategy development, information collection and report compilation takes time.

Consequently, REACHLaw advise that you begin the process of preparing your application as soon as possible.

I have an SME company. How can I handle the cost of Authorisation application and ECHA fee for Authorisation?

For the cost of the application, we have developed a successful method for SME companies to apply for authorisation with smaller price tags. In the so called “group DU application” a group of SME DU’s all applying for authorisation can apply together and also share the costs incurring from the Authorisation ECHA fee and the cost of preparing the application. In order for the Group DU application to be successful, the applicants should be closely similar in their business model, size of their business and of course in their use of the hazardous substance. The applicant might already know some other related businesses also interested in the possibility to apply for authorisation, but we at REACHLaw can also do market analysis and look for the co-applicants to share the costs with you.

s my use exempt from Authorisation?

Some uses are exempt from the need for Authorisation, for example if your use is as an on-site or transported isolated intermediate; use in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC and Directive 2001/83/EC {Art. 2(5a)}; Use in food or feedingstuffs according to Regulation (EC) No 178/2002; Use in scientific research and development; etc.

If you are unsure as to whether your use is exempted, REACHLaw can provide exemption legal analysis to clarify you particular situation. Please contact us for more information.

My industry is lobbying to have our use exempt from Authorisation but the Commission hasn’t made any decisions yet. What should I do?

Preparing an application for Authorisation takes time, with information gathering, analysis, report generation, approval and submission. If there is any chance that the Commission could potentially decide against your exemption, we would advise to begin to prepare an Authorisation application as a risk management measure as soon as possible to ensure submission before the Latest Application Date.

This will allow you to continue your activities, safe in the knowledge that, should the Commission decide against the exemption that you are relying on, you have a fall back option protecting your business continuity.

REACHLaw has facilitated companies in several industries to investigate and/or prepare and submit applications as risk management measures, e.g. mineral processing and in vitro diagnostics.

What are the LAD and the Sunset Date and what do they mean?

The Latest Application Date (LAD) is the latest date that an Authorisation application can be submitted to ECHA to ensure that transitional arrangements apply.

The Sunset Date is the latest date that a substance on Annex XIV can be used in the EEA without an Authorisation having been applied for.

What does Transitional Arrangements mean?

Transitional arrangements is the name given to the process of allowing an applicant for Authorisation (and its supply chain where there is an upstream application) to continue using the Annex XIV substance after the Sunset Date for the use applied for. These transitional arrangements remain in place until the European Commission reaches a decision on whether the application should be granted or not.

Once the decision is made the transitional arrangements cease and the decision from the Commission and its conditions become law.

I am a Downstream user and I am not sure if I am in the Supply Chain of the current Upstream Authorisation Application. What should I do?

The first thing you need to clarify is whether you are in the supply chain. You will need to contact your upstream supplier to find this out.

If you are not in the supply chain then you will need to understand if the use applied for covers your specific use. If this is the case, it might be possible for you to change to the supply chain covered by the Authorisation.

If the use is not covered then you will either need to apply yourself for your particular use, or cease using the Annex XIV substance. If you would like to apply for Authorisation, please contact us at REACHLaw for a no-obligations teleconference to discuss your situation.

Is my substance on Annex XIV?

The current list of substance on the Authorisation List can be found here: https://echa.europa.eu/authorisation-list

This link also gives information on the Latest Application Date and Sunset Date of the substance.

Advantages of REACHLaw’s Authorisation services:

DU Applications:

The Authorisation process can seem quite daunting. REACHLaw has gone through the process many times, however, and are ready and able to support your application from the very beginning until the very end.

We will advise you on the type of information that is required, prepare the application in-line with the expectations of ECHA and the committees, and be there with you at all the meetings with the Authorities throughout the process.

Being based in Helsinki gives us that added bonus in that we attend everything in person and, in fact, several members of our team have previously worked in ECHA!

Group Applications:

In addition to the above, REACHLaw has a huge amount of experience delivering Authorisation applications for a wide array of industry sectors. In addition, we have prepared different types of applications, e.g. upstream, downstream, group downstream and sector specific.

Tailoring each application to the specific requirements of the client(s) regarding confidentiality and competition law is a key step in our process. Some of our applications involved supply chains of up to 100 different companies, while others were single DU applications.

This has meant that we have been required to gather information from multiple sources, most of whom were in direct competition with each other. Knowing that confidentiality was paramount to gaining data from the supply chain, REACHLaw has implemented a process to ensure that companies can be assured that their information will be treated with the strictest of confidence.

Being an independent 3^rd party has allowed us to act as a trustee, ensuring there is no breach of competition law.  

Need support with your application? Contact Us! We would be very glad to help you!

What is important in AoA?

In the Analysis of Alternatives (AoA) the applicant should be able to identify all relevant alternative substances and technologies and determine whether they are feasible or not. For each identified alternative, the applicant should consider several aspects e.g. technical and economic feasibility etc. In our experience, it is important to include all information on past and currently on-going studies the applicant has conducted on alternative substances and technologies. The applicant should provide evidence of real efforts made.

How do I identify alternatives?

Defining the use description of the hazardous substance and making it representable for the applicant’s need can be a make-or-break factor in a successful Application for Authorisation. Defining the use well helps to discard alternatives that do not e.g. fulfill the process requirements.

At REACHLaw, we have huge experience in helping clients to identify the relevant information about the alternatives from the applicant and their upstream/downstream supply chain via specified questionnaires.

More on how to identify alternatives can be found in ECHA guidance on Application for Authorisation pages 46-55: https://echa.europa.eu/documents/10162/23036412/authorisation_application_en.pdf/6571a0df-9480-4508-98e1-ff807a80e3a9

What information is needed to analyse alternatives?

For the shortlisted alternatives, the applicant has to present detailed information on the technical and economic feasibility, availability and risk reduction potential. In the technical feasibility section, the applicant should show that the alternative substance or technology does not perform as well or in a high enough level in the process conditions.

In the economic feasibility section, the applicant should list all the costs resulting from substituting the hazardous substance with the alternative, e.g. investment costs, raw material costs etc.

In the availability section, the applicant should consider whether alternatives are available by the sunset date.

In the risk reduction section, the applicant should demonstrate that the alternative substance is less hazardous or at least as hazardous as the substance that it is going to be substituted.

At REACHLaw, we also consider how worker exposure would change if the alternative substance would be used in the current process.

Will all the information about our testing of alternatives be made public, even for our competitors?

The applicant should prepare two versions of the application, the public and confidential version. The confidential version will include all information, this version will only be made available for the authorities; while the public version, which will be made public for everyone through ECHA webpages. In addition, it is also necessary to develop reasoning behind the claiming of information as confidential, using ECHA’s format.

REACHLaw has experience in managing these types of applications and will bring this experience with us when supporting your Authorisation application.

I have already identified a substitute but it is not available before sunset date. Do I still need to apply?

In case the applicant has identified a valid alternative but it is not available before the sunset date, the applicant needs to apply for authorisation. This could be the case when for example testing of the alternative is still ongoing or certification or qualification steps will take a long time to complete. An explicit Research and Substitution plan to demonstrate how substitution will occur is then needed also. The substitution plan is provided to assure the authorities that the substitution will take place in the time requested.

Need support with your application or parts of? Contact Us. We would be very glad to help you!

What is the aim of the SEA and why is it so important?

The aim of the SEA is to analyse and document whether the socio-economic benefits outweigh the risks imposed by the use of the substance in use. An SEA is required for an authorisation application if no adequate control route for use of the substance exists.

Preparation of a SEA is considered mandatory for reasons of due diligence, even if the substance was eligible for the adequate control route. This is because if the RAC doesn’t agree with the applicant’s conclusion of demonstrated adequate control, the application will automatically go through the SEA Route. With a good quality SEA you can demonstrate that the benefits outweigh the risks of your use in a manner that is approved by the regulator. It must include the justification for granting an authorisation and provide a clear view of the costs and benefits of a granted authorisation. That is the key for a successful authorisation application and the continuation of your business.

What is important in SEA?

First of all the approach needs to be systematic and the scope relevant. It is essential to identify the “non-use” scenario early in the process and consider all possible types of responses to non-availability of the substance. An important question that needs to be answered: What would your company, your supply chain and your customers do in the “non-use” scenario? Consultation with the relevant stakeholders is also very important. You will probably need confidential business information from both your company and the relevant supply chain. The impacts should be assessed and presented in transparent manner to produce an unbiased SEA. Minimising and analysing uncertainties in your assessment is critical to give the regulator a comprehensive insight into your case.

How do I assess impacts in an SEA?

Human health and environmental impacts: These impacts cover all possible effects directly related to the toxic, eco-toxic or physiochemical properties of the substance. These impacts also cover any other health and environmental impacts occurring in all affected supply chains with respect to the substance or introduction of alternative substances or technologies.

Economic impacts: These are the costs or savings to manufacturers, importers, downstream users, distributors and consumers in the supply chains.

Social impacts: These are all relevant impacts which may affect: workers, consumers and the general public and are not covered under health, environmental or economic impacts.

Wider economic impacts: These impacts have macro-economic implications such as economic growth, inflation, and taxes. These types of effects follow from the distribution of the economic effects and how the relevant markets function.

What kind of expertise I need to prepare a good quality SEA?

Preparing an SEA can be difficult in many ways. Common mistakes includes e.g. lack of consideration for all significant impacts, lack of awareness of respected data sources and no attempt to quantify where possible and appropriate. In addition to the project management skills, SEA preparation requires experience in toxicology, human health and environmental knowledge, economics, finance and sociology. An SEA must be prepared by highly qualified professionals because many of the impacts and the risks that they pose and their significance, can be challenged and many of the methods used are relatively complex.

How can I minimise uncertainties in my SEA?

Include methods and data sources you have used and analyse uncertainty arising from each of them throughout the whole document. Document all uncertainties you have found. It is important that uncertainties are identified and described throughout and when carrying out the various stages and steps of an SEA. This will help to ensure that good quality data is used to conduct uncertainty analysis. During the SEA, the uncertainty analysis can be used as a tool to identify what further information generation would reduce uncertainties most and therefore be applied to decide on the most cost-effective iteration strategy in order to arrive at a robust SEA.

How do I know what information I will need when making my Authorisation SEA?

REACHLaw has a huge amount of experience with applications for Authorisation and understand the requirements of the Committee for Socio-economic Analysis (SEAC). Using this knowledge, we have developed standardized questionnaires that we will forward to you when we are assisting you with your application. Once we have this information we can then begin to develop your SEA.

Need support with the SEA? Contact Us. We would be very glad to help you!

Do I need a CSR when applying for an Authorisation?

Yes. The CSR is one of the key documents that is used by the authorities to assess the validity of your application. You will need to provide a CSR irrespective of the route of your application, i.e. the adequate control route and the Socio-economic route.

I have Registered and have access to the Registration CSR. Can I use this for my Authorisation application?

There are a few factors to consider here. The first is whether your SIEF agreement allows the use of the Registration CSR for any purposes other than Registration, e.g. Authorisation. Some agreements are specifically limited in this regard.

Secondly, you must consider if the Registration CSR provides a good description of the exposure for the use that you want to get Authorised. It is likely, therefore, that a Registration CSR would need to be updated and adapted for an Authorisation application.

Nevertheless, some information contained within the Registration CSR may be brought across and used.

I have not Registered. Do I need to generate a new CSR for my Authorisation Application?

Yes. If you are, e.g. a Downstream User (i.e. not a registrant) you will need to generate your own CSR for Authorisation.

If you want to use the Registration CSR for such an application, you will need to contact the data owners to get permission to use the data.

However, as is explained in the above, you must consider if the Registration CSR provides a good description of the exposure for the use that you want to get Authorised.

What is the difference between a CSR for REACH Registration and one for REACH Authorisation?

A Registration CSR is used by a SIEF to cover all the intended uses of the supply chain. These uses can be many and varied, in many different industry sectors and for multiple sites of the SIEF members throughout the EEA.

An Authorisation CSR, however, can be much more specific. It only covers the exposure resulting from the worker tasks for the specific use of the Authorisation application and for the SVHC property for which the substance has been listed on Annex XIV and for the sites covered by the application. Also while modelled data can be used for an Authorisation CSR, there is an expectation by the authorities that relevant, specific measured data is used.

Nevertheless, group applications are also permitted with Authorisation. As has been seen with some group applications submitted already, if the application strategy is not well developed and the exposure is not deemed representative, then the authorities will likely shorten the Review Period.

What happens to the CSR after the Sunset Date?

After the Sunset Date, if an application for Authorisation has been made, the Registration CSR needs to be updated to bring it in-line with the uses applied for in the Authorisation application. This means is that all uses that all uses for which an Authorisation has not been applied for must be deleted.

In addition, it is possible that following the decision from the European Commission a further update of the Registration CSR will be required.

Need help with your CSR? Contact Us! We would be very  glad to help you!

AfA team’s Winter

REACHLaw’s Authorisation team (AfA team) has been working with many projects during this year and the schedule looks busy also for the upcoming winter. We are glad to be in contact to you through our newsletters.
 
The REACH Authorisation process now has new requirements for the submission of substitution plans when ”alternatives are considered to be generally available”.  These requirements originate from March 2019 when the General Court of the European Union annulled an authorisation for certain uses of lead chromates which Commission had already granted. It follows from the judgment that an authorisation may be granted if the applicant submits a substitution plan.
 
Substitution plans have been required for adequate control route but now since July 2019 also for the socio-economic route. Substitution plan is consisted of factors affecting substitution, timetable with milestones and monitoring. The “public version” of the substitution plan is part of the package on broad information on uses. As such, it will be published on ECHA’s website for the purpose of the public consultation on alternatives for each application for authorisation.
 
New substances to be listed to the Authorisation List are other important recent development. 11 new substances have been accepted to the Authorisation List. The new entries include substances used as polymer additives, functional fluids, crop protection, health care and coatings.  These new substances will need authorisation to be used after the sunset date. Figure below gives some insight which sectors will be affected.

Contact Us 

You can find more info on our experts here and our services here. We will get back to you with timely topics in the future but if you have any questions related to substitution plans or related to authorisation process – please don’t hesitate to contact us.
 
With best regards,
AfA team

All uses of an Annex XIV substance must cease after the Sunset Date, unless there is an applied for or granted Authorisation; or there is a clear, accepted and documented exemption.

But what if there is an unclear case? What if you determine your substance use to be intermediate, and consequently rely on the on-site isolated intermediate and transported isolated intermediate exemption, but ECHA disagree? What if there is some doubt and clarification is required, all the while the Latest Application Date and Sunset Date are approaching?

There are clear cases where the use of a substance is exempt from the need for REACH Authorisation, for example if the substance is present in a mixture at a concentration below 0.1 %(w/w) or on the basis of existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled, for example use in biocidal products within the scope of Directive 98/8/EC; or use in medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC and Directive 2001/83/EC.

Where there is some doubt, relying on an exemption can pose real problems for any business, and Authorisation can be used as a risk management measure to alleviate this risk.

Recently confusion has been growing in the in vitro diagnostics (IVD) industry which relies on an exemption for Scientific Research and Development for test kits following the inclusion of the group of substances 4-(1,1,3,3- tetramethylbutyl)phenol, ethoxylated – (also known as ‘4-tert-OPnEO’), which includes Triton X 100, a surfactant used by the industry. While it appears that some uses are covered by the SR&D exemption, it is unclear for many others. With the approaching Latest Application Date in 2019, the time required to prepare and submit applications for substances with such complex uses, and the strict regulatory environment governing the IVD sector, it is a huge issue with potentially wide-ranging impacts for the companies themselves and patient care.  

LET’S LOOK AT THE FOLLOWING CASE:

In the past a REACHLaw client relied on the use of their substance as an intermediate, however, following a compliance check, ECHA deemed that their use did not fulfill the intermediate definition and requested them to make a full registration, which, in turn, had far reaching consequences for the company as the substance had been placed on Annex XIV. As there was a risk that the appeals process would, at worst, result in ECHA’s Board of Appeal (BoA) agreeing with the ECHA position or, at best, only be complete after the Sunset Date for the substance, the client had to quickly decide on a course of action: cease use of the substance after the Sunset Date until a decision on the exemption was made, or prepare an application for Authorisation. They chose to protect their use through the Authorisation process, while simultaneously appealing to BoA.

This choice resulted in the granting of a 12 years review period. This provided security for their process irrespective of the decision from the BoA. Subsequently, the BoA found in favour of the client. Nevertheless, the dual strategy of appealing while applying provided business certainty and the strategy was vindicated.

What should you do if you are impacted in this way?

The first thing is to identify if and what uses are definitively covered by the exemption. This could be performed by outside consultation in the form of an exemption study. If it is still unclear for some uses, then you must decide on a company strategy. Ask yourself, is the cost of applying for Authorisation worth it compared to the cost of not being able to use a substance in a particular process if the exemption is not confirmed? In the vast majority of cases an Authorisation application will be considerably less expensive, even taking into account consultant costs and ECHA fees.

REACHLaw Support

REACHLaw have supported companies in the IVD and other industries to understand their obligations through exemption studies and Authorisation Risk Management strategy development. This allows companies, who are currently engaged in lobbying for an exemption, to select a phased project approach. In this way, should the exemption be confirmed, the Authorisation project can be put on-hold and the costs associated with any pending phases stopped. This ensures that costs are kept to a minimum, while ensuring that valuable time to develop and prepare an Authorisation application is not lost.

It has been said that an economist is: “Someone who solves a problem you didn’t know you had, in a way you don’t understand.”

In the context of REACH Authorisation, however, the problem is, in most instances, quite clear: stop using the Annex XIV substance and face the economic consequences of that, or try to prepare an Authorisation application while justifying the continued use of the substance on socio-economic grounds. The complexity and nuance of undertaking such a task, coupled with the pressure from the potential consequences of not doing it correctly, could mean that it might be more prudent to allow an experienced practitioner to do it for you. Nevertheless, in this newsletter we try to demystify the SEA.

Where to Start?

1. Definition of the relevant supply chain

The relevant supply chain can be identified by determining the material flow related to inputs to and outputs from the uses covered by the authorisation application and economic flows through affected markets. Supply chains are case specific but they usually include suppliers, the applicant, distributors, customers and possibly even consumers.

2. Definition of the in-use scenario

This is the baseline scenario; business as usual, and describes the situation that would arise if no regulatory action was taken. A proper in-use scenario should include an historical trend, current situation and future forecast of the business for all relevant players in the supply chain. The focus on the applicant is, of course, the most significant.

3. Definition of the non-use scenario

This is the scenario in which an authorisation application for use of a substance is not granted and you must stop using it. How would you and the relevant actors in the supply chain react? Credibility is hugely important when defining a non-use scenario. If it is not credible then it might be questioned, weakening your argument for authorisation.

4. Definition of the impacts

What kind of impacts the non-use scenario causes in the relevant supply chain in terms of human health, environmental, economic, social and wider economic impacts? These should be expressed, when possible, quantitatively. Monetisation is the key which enables the comparison between the in-use and non-use scenario in the analysis phase. Correct and reliable monetisation can prove to be very tricky.

5. Analysis

Last but not least is the analysis where the focus is in the differences between the in-use and non-use scenarios i.e. comparing the risks against the benefits of a granted authorisation in monetary terms.

Sometimes the goalposts can change; meaning that more information is required for example, if there is an additional SVHC property of your substance. The hot topic at the moment is how to manage human health and environmental impacts with endocrine disrupting and other environmentally hazardous substances. As we speak ECHA is preparing Q&As which may clarify what approach can be taken. Before the publication we can only say for certain that a well justified non-use scenario, monetised benefits of continued use, qualitative information on releases, together with quantified releases and environmental concentrations, description and justification of risk management measures should be enough to conclude that benefits outweigh the risks.

The next latest application date for Applications for Authorisation is less than a year away on the 4^th January 2019, with two other latest application dates also coming that same year. In particular, the latest application date of 4^th July 2019 should be interesting, with the substances in the group 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated, including for example the widely used Triton X-100, likely to result in many new applications.

So what if you have identified a use for these substances but you still have not even started to prepare an application? Applications for Authorisation are complicated procedures and require the input from a variety of people with different skills, backgrounds and knowledge. Nevertheless, with experienced guidance, and depending on the type and number of uses, 1 year should be sufficient to prepare an application. In order to help you, we have broken down the timeline for an Application for Authorisation, highlighting the milestones and specific issues related to them.

The timeline for an Application for Authorisation-process

An Application for Authorisation is comprised of three distinct documents: An Analysis of Alternatives, Socio-economic Assessment and Chemical Safety Report. These documents require the input of a whole team of people with expertise in R&D, process engineering, HSE, finance and sales. Because of the complexity and scale (dependent on the number of uses and strategy used to apply for authorisation) the development of an Application for Authorisation can take about 1 year to just prepare the application reports.

Before the final application is submitted to ECHA, the Agency offers the possibility to discuss your application in a Pre-Submission Information Session (PSIS-meeting). This meeting allows ECHA’s experts, who are used to working closely with the opinion making scientific committees, give their view on the draft application, and provide advice and constructive feedback. In our experience these meetings have been very informative. It has been good to get another view on the application which helps to highlight sections that still might need elaboration. Therefore, we strongly recommend all applicants to use the opportunity to get feedback on the application before it is submitted.

The submission to ECHA should happen before the latest application date, but ECHA encourages applicants to send in their applications in certain periods so that they can better organise their work. These periods are called “submission windows” and there are four windows every year: 7^th to 21^st of February, May, August and November. With the example of Triton X-100, the latest submission window of the 7-21 May is almost 2 months before the latest application date (LAD in 4^th July 2019). It is important, therefore to understand that you might not always have time until the very end of the latest application date to submit your application.

Post-Submission Process

After you have submitted your Application for Authorisation, the next milestone is the public consultation which lasts for 8 weeks. This is the period when your application is available for everyone to see. It is designed to attract comments from alternative providers, non-governmental organisations and other interested third parties. .

Following the public consultation ECHA (usually) organises a Trialogue meeting between the rapporteurs of scientific committees, the applicant and third party representatives (hence the name: Trialogue). The third party representatives invited to the meeting are usually industry representatives, environmental organisations or alternatives providers who made comments during the public consultation phase. In this meeting, the applicant has the possibility to clarify any issues the rapporteurs have raised when reviewing the application, and answer any questions the rapporteurs may have presented to the applicant.

The ECHA scientific committees have a legal deadline to deliver a draft opinion on the authorisation within 10 months of receiving the application. It usually takes another two to four months before the final opinion is published depending on whether the applicant wishes to comment on the opinion or not.

The European Commission does not, however, have a similar legal deadline for giving their decision on whether to grant an authorisation. In our experience, it can take up to a year from the final opinion from ECHA to when the Commission has made the final decision. Thus, it can take more than two years to receive the decision on authorisation after submitting the application. In the vast majority of cases this has meant that the sunset date, the date after which the use of the substance is banned without an authorisation, has already passed before you receive your authorisation decision.

But how can you carry on using your substance if you have applied for authorisation but you have not received any decision from the commission before the sunset date?

Do not worry. You can carry on using the substance without a decision on authorisation as long as you have applied before the latest application date. These are called “transitional arrangements”. Therefore, it is crucial that you submit your application before the latest application date to guarantee that you can continue using the substance in your production.

If you submit your application after the latest application date, you are not eligible for the transitional arrangements and you need to stop using the substance after the sunset date. This can have severe impacts on your business as you need to stop any processes where the substance is involved. This of course affects your ability to serve your customers, which could lead to losses in sales, market share and may even hurt the reputation of your company.

In conclusion, we strongly recommend that you start the application process early, with a partner that has experience in applying for authorisation, to guarantee your access to the market and mitigate any risks posed by the authorisation requirement.

If you are familiar with REACH authorisation, at this point you are probably already aware that substances with endocrine disrupting (ED) properties have been placed on Annex XIV.  As a result various industrial users have roughly a year to prepare applications for the use of these substances if companies think that they are not capable of substituting before 2021. They should start preparing an Application for Authorisation (AfA) without delay and submit it at the latest by 4^th of July 2019, which is the latest application date for these substances. ED substances in authorisation are a hot topic lately, especially with regards to preparing the Socio-economic Analysis (SEA). But why is that? This newsletter briefly explains what all the fuss has been about.

Before ED substances were added to the authorisation list, it contained substances mostly classified as carcinogenic, mutagenic or toxic to reproduction (CMR), whose properties pose risk to human health. In SEAs for CMR substances the risk to human health is monetised via excess cancer cases and willingness-to-pay estimate. Monetised risks are then compared to monetised benefits to reach a conclusion whether an AfA is justified or not. This is a relatively straightforward exercise, and the methodology has been adopted universally by industry and authorities.

ndeed, the principal purpose of a SEA has been, and will be, to demonstrate that the benefits of continued use outweigh the risks. That is the origin of the fuss around ED substances. They pose risk to the environment and it is not as straightforward to monetise this as a CMR substance. At the moment, there is no universal method to monetise this environmental risk.

The monetisation of ED substances is seen as very difficult for two reasons. Firstly, ED substances can remain and accumulate in the environment over long periods of time. In the long-term, the effects of this accumulation are unpredictable, and exposure is difficult to reverse because ending releases will not necessarily result in a measurable reduction in exposure. Secondly, deriving thresholds or dose response relationships is extremely difficult for these substances. With current methods, it is problematic to establish a no-effect concentration for the environment, and to estimate reliably how they behave in the environment and what the consequences of releases are.

Even without full quantification of risks, however, it is still possible to assess environmental risks. As the relevant guidance documents show, it is possible to use qualitative and semi-quantitative approaches. When the benefits of the continued use are significant and the emissions are properly controlled, a qualitative assessment should be enough. In a more complex case, in-depth semi-quantitative analysis may be needed. This would include an assessment of the monetised benefits of continued use and quantified release estimates, complemented by qualitative information and a cost effectiveness analysis based on the emissions reduction and compliance cost related to the use of the substance.

One thing stays luckily intact. Assessing the benefits of continued use of environmentally hazardous substances does not differ from other AfAs. This assessment is based on the non-use scenario, where the substance is no longer available for use, and its impacts on society and the applicant

Given the experience of some broad upstream applications for Authorisation, like MOCA and the CTAC application covering many hundreds or thousands of downstream users, with complex supply chains and hidden dependencies, what is the next step for companies currently covered by these applications?

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Initially when the Authorisation process was starting it was envisaged that the process would be similar to that of REACH registration. Upstream actors would apply and these applications would cover all the uses of their downstream supply chain.

In this way a company that, for example, formulates a mixture would secure its own market while ensuring good function of the internal market to its customers, their customers and their customers’ customers.

Issues, however, arose with this Authorisation application strategy; it became clear quite early in the life of the process that such applications, unless very specifically defined, would fall foul of uncertainties in the mind of the authorities. Nevertheless, instead of failing the applications due to the level of uncertainty, it seems that the approach taken was to give short review periods of 4 years as well as adding Conditions of Use to the approval.

So what should you do if your use has been covered by one of these upstream umbrella applications that has only received either a 4 years review period recommendation from ECHA, or a 4 years review period from the Commission?

Well the first thing to consider is whether it is possible for you to substitute in the given timeframe?

If the answer is Yes, then there is nothing to worry about and you should substitute!

But if the answer is No, then you will need to come up with a strategy to protect your use of the substance. You should make sure, however, that, as a minimum, you implement any Conditions of Use from the upstream application that covers you at the moment.

Some Authorisation strategies that you might consider could be:

• Formulator/re-packager covering specific sectors of interest:

If you formulate, re-formulate or re-package a substance and sell this to your customers who then use it, for example in surface treatment, an application would need to encompass the formulation, re-packaging as well as your customers’ use.

Such a strategy could be structured in a way that reflects the priorities of your company. This could mean that the application focuses on, for example the most important industry segments for you that would maximise the return on investment in applying for Authorisation, i.e. a so-called sector specific group applications. 

It is also the most specific type of group application and can reduce the potential uncertainty about granting an application from the decision makers.

A potential drawback is that the upstream supply of a particular substance might not be guaranteed, especially if the Authorisation uses covered are for niche sectors.

In addition, if a company is located in the UK, in order to protect your uses and the uses of your supply chain, we would suggest considering an Authorisation application as a Risk Management Measure. This is because should the UK remain a REACH territory after its exit from the EU, there might not be enough time to begin preparing an application by the time it is known what the UK’s status will be.

• Hope that the current application will be renewed and rely on this to cover your uses:

This could be a risky scenario for your company as you must be able to quickly adapt to a decision by the upstream to not apply.

As the current mood from the authorities around such broad upstream applications is negative it is possible that to re-apply in this manner might be difficult. Especially considering that the ECHA opinions for these types of applications have specified that more detailed and representative information from all members of a supply chain is required; this information being extremely difficult or impossible to collect.

Possible problems with this Authorisation option are that factors such as the non-use scenario, alternatives landscape, exposure and number of companies within the supply chain may differ, company to company and supply chain to supply chain.

Nevertheless, it could be useful to approach the upstream actors to check if they are considering a re-application. Should this be the case it is important to make sure that your use(s) and those of your supply chain are covered. You must also ensure that any Conditions of Use for the original application are in place so that you are actually covered.

• Rely on your downstream customers applying:

Downstream end user applications for Authorisation remove some levels of uncertainty that can be present in broad upstream applications. Even if a group of downstream companies apply together the level of uncertainty is reduced compared to broad upstream applications covering multiple sectors, all with potentially different alternatives landscapes, substitution timeframes and non-use scenarios.

Ultimately this would be the most specific type of application, however, it can limit your company’s market if not all its customers are involved in the consortium.

Furthermore, only the named applicants would be covered by a possible Authorisation from the downstream in this way, meaning that new/potential customers in the EU would not be covered and they would require their own Authorisation for use your products.

To Summarise:

Should your upstream Authorisation holder not re-apply, your uses will no longer be covered which would have the consequence of meaning that your uses of a substance or formulation,  and those of your customers, will no longer be legal in the EU.

Given the complexity of such broad upstream applications it is probable that at least some of these Authorisation holders will decide not to submit a review for their current Authorisation applications.

Furthermore, if you are considered a Downstream user covered by an upstream Authorisation, any application by you will be considered an “Initial” application and not a review of a current application.

This means that if the Latest Application Date has already passed, you will NOT be covered by any “Transitional Arrangements” that an Authorisation holder might benefit from if they submit a review report 18 months before the end of the “review period” of their current application.

With many potential pitfalls, we would advise that companies commence actions to protect their use(s) of SVHC substances with 4 years review period opinions from ECHA as soon as possible and by early 2019, at the latest to ensure that a decision comes from the European Commission before the end of the upstream application review period.

A substance becomes a substance of very high concern (SVHC) when it meets one or more of the criteria such as carcinogenic, mutagenic, toxicity for reproduction, PBT; and/or if there is scientific evidence of possible serious effects to human health or the environment. Once this type of substance is identified, one of the possible Risk Management Options open to the authorities is Authorisation, meaning that any user of the substance must apply for a specific permission for that use.

The Chemical Safety report is one of the elements required when assessing the safe use of an SVHC in an Authorisation application. It describes the uses applied for covering the properties of the Annex XIV listing and includes a chemical safety assessment (CSA).

The CSA consists of the evaluation of all available information with the purpose of assessing the risks arising from the use of the substance covering all the life cycle stages of the use of the substance, from procurement to waste, as such or in a mixture.

An evaluation of exposure is developed, including consideration for any Risk Management Measures (RMMs) like technical controls, operational conditions and use of personal protective equipment (PPE), etc. that are in place for the process to avoid or reduce the human exposure. Furthermore, the Environmental exposure identifies the environmental emissions that should be minimised using technical controls, operational controls and suitable waste management measures. Moreover, an assessment of the likelihood of exposure to humans via the environment is also included when this is considered necessary.

This information will be reported in exposure scenarios which aid the authorities in deciding if there is safe use of the substance and/or products containing the substance by demonstrating the controls in place. Consequently, the information reported in the CSR is crucial for a successful Authorisation application.

In summary, an accurate assessment on how the chemical is used will be documented in the CSR and it will serve to prove safe use of the substance and/or products containing the substance.

What can be done to ensure an effective assessment?

During the course of the assessment, questions like Is the substance in general suitable to be widely used by untrained workers in small business and by consumers? Which types of exposure controls are needed at work places to handle the substance safely? or How much of a substance can be used per day at an industrial site without onsite pre-treatment of wastewater? will facilitate the elaboration of more precise conditions and allow the refinement of exposure estimations. Likewise, in many cases, the use of the substance is geographically spread across Europe and the identification of all the sites where it is used is critical. Therefore, efforts need to be put in the understanding the What, Where and How your supply chain makes use of the SVHC substance or SVHC containing mixture.

Potential consequences for your business due to inappropriate CSRs

It needs to be understood that substances on the Authorisation list are considered the worst of the worst in terms of potential negative impacts to humans or the environment from exposure. For these SVHC substances, in our experience, the authorities have strict interpretations of what they will think are suitable risk management measures, and will always s augment these with their own suggestions in their opinion.

A chemical safety report is, consequently, key to demonstrating to the authorities that all measures in place by you and your supply chain are sufficient to mitigate any risks from the hazard. A CSR that has been prepared correctly for an Authorisation application reduces the uncertainty in the eyes of the authorities and strengthens the case for a positive decision on Authorisation.

Furthermore, from a practical point of view, the CSR is the basis for the compilation of extended Safety Data Sheet (e-SDS) that should be updated and distributed to your supply chain on granting of an Authorisation. It is, therefore, not only important for you that the CSR is prepared properly, but also for your downstream supply chain. 

Once completed, what benefits can we get from a CSR?

Adherence to the RMMs in the CSR will contribute to the safe use and handling of SVHC substances, ensuring your workers, the public and the environment are protected from potentially hazardous and negative effects.  It can also act as a baseline from which additional RMMs can be added, ensuring continuous development in the safe use of such substances within your processes.  

Furthermore, the exposure scenarios contained within the CSR should be appended to the extended safety data sheet (e-SDS) which allows for communication of the risks and hazards along the supply chain, when required.

In short, this document will help you to maintain and manage your product and processes safely, while giving the authorities confidence that you are doing everything in your power to ensure the minimization of risks from the use requiring Authorisation.