How to build a good chemical safety report

At the Lead Registrant workshop held last week in Helsinki, ECHA, the European Chemicals Agency, stressed once again the importance of a good chemical safety report (CSR) as key to ensure better protection of human health and of the environment.

A good CSR ensures information passed down to downstream users are of value to ensure safe use of the substances, and that the risks are adequately controlled evidenced by appropriate and meaningful risk assessments.

The whole process of carrying out a chemical safety assessment (CSA), as key part of the CSR is new for many companies, understanding the expectations of what a CSR should contain is still ongoing but lessons are being learnt.

But first of all what is a CSR?

Chemical Safety Reports (CSR) combine and consolidate the information contained in the IUCLID5 end points.  The purpose is to make a risk assessment comparing the hazard assessment collected from the data studies versus the exposure assessments of chemical substances for workers, consumers and the environment.

A manufacturer or importer of a substance in quantities of 10 tonnes or more per year needs to prepare a chemical safety assessment (CSA) and needs to document this assessment in their chemical safety report (CSR) as part of the joint registration dossier. For hazardous substances there is an additional obligation to perform an exposure assessment.

The Chemical Safety Report submitted to ECHA as part of the registration dossier must document the results of the CSA, Exposure assessment and Risk Management (if required).

Important aspects of the CSR are to build exposures scenarios based on accurately defined and appropriate use descriptors, calculate the exposure estimates with the risk assessment tools and finally calculate the risk characterisation ratio comparing the hazard assessment against the exposure assessment.  Exposure scenarios have to be documented in the Chemical Safety Report (CSR) and communicated to the downstream users as annexes to the Safety Data Sheets.

To prepare the ES, suppliers need to liase closely with their customers to ensure that the scenario for exposure is realistic, feasible and conversely, once prepared, the user must not deviate from the operational conditions and risk management measured outlined in the ES.  When one considers the aspect of enforcement, it is important to realize that the CSR and the eSDS will serve as documentary evidence to support what practically has been undertaken within the workplace.

ReachCentrum, in collaboration with TNO Triskelion is offering a series of training courses combining CHESAR, the tool from ECHA helping companies to carry out their CSA and to prepare their CSR, the Advanced Reach Tool (ART), and Stoffenmanager, both are web-based occupational risk assessment and risk control tools for companies. Further information on these trainings, to be held on 13, 14 and 15 February is available here.

On 27 and 28 March 2012, ReachCentrum and Peter Fisk Associates are organising two one-day workshops to help you understand how to focus on the vital information that is being conveyed through your e-SDS. Further information on the workshop “e-SDS and Exposure Scenarios – Their Interpretation and Use” is available here.

REACH: do you know what virtual learning is?

To help you work in a cost-effective manner, ReachCentrum is launching a series of “Virtual Training sessions” in 2012, providing an ideal combination of flexibility and knowledge transfer conveniently – anywhere you have an Internet connection. Virtual training delivers the … Continue reading →

Authorisation process: what about OR?

In December 2011, the European Commission informed ECHA, the European Chemicals Agency, that in their view an Only Representative (OR) of a non-EU manufacturer can also apply for authorisation. Authorisation is the REACH process related to controlling the risk of substances of very high concern (SVHC) by authorising just specific uses and eventually when economically and technically feasible replacing them by suitable alternatives.

Substances on the Authorisation List cannot be placed on the market or used after the so called “sunset date” – unless an authorisation has been granted for a specific use, or the use has been exempted from authorisation.

Following the European Commission information, ECHA updated the webforms to allow ORs to send their applications while developing long term functionalities in REACH-IT. The relevant Data Submission Manual Part 22 – How to Prepare and Submit an Application for Authorisation using IUCLID 5 is also being updated and will be published once the new version of IUCLID is released, which is currently expected to be during summer 2012.

ReachCentrum has developed a service to support  companies ( being manufacturers, importers, downstream users and OR) that have substances that are eligible to be added to the Candidate List or that are already on the Candidate List and that need to file an authorisation dossier.

The main objective of the Authorisation Support Service is to assist the customer in performing all the procedures and tasks necessary within the framework of a REACH authorisation application, including project management, communication with co-applicants and with authorities, legal and financial management.

How does the service work and which steps are covered?

1. Comment on Annex XV dossier proposing identification of SVHC.
2. Comment on recommendation for inclusion in Annex XIV (Substances subject to Authorisation).
3. Submission of application for an authorisation (If a socioeconomic analysis is needed, a service provider will be subcontracted to perform this task).
4. Submission of information on alternative substances or technologies and socioeconomic impacts.
5. Notify agency of intention to comment on the draft opinion of the agency’s committees for risk assessment and socioeconomic analysis.
6. Comment on draft opinion of the agency’s committees for risk assessment and socioeconomic analysis.
7. Update the safety data sheet or provide downstream users and/or distributors with details of the authorisation in another way.
8. Review of authorisation

Further information on the ReachCentrum Authorisation support is available here. A REACH Authorisation webinar will be also held on 7 February 2012 by our Legal officer Vincent Navez. Further information on Authorisation and ECHA is available here.

Unique REACH 2013 Support Programme for SME

Are you a Small and Medium Enterprise (SME) dealing with REACH regulation? Are you looking for some help? You should then know that in line with the “REACH 2013 – Act Now!” campaign launched by the European Chemicals Agency to raise awareness of REACH, a unique industry initiative has been launched to provide SMEs with a series of high quality REACH support products and services from well-known providers, in a single, low-cost promotional ‘bundle’.

The REACH 2013 Support Bundle is a worldwide initiative from chemSIX, supported by industry leaders Chemical Watch, ReachCentrum and Reach Delivery and is designed to make it very easy and attractive for companies to get access to the best information, knowledge and support on a small budget. In addition, it stimulates SMEs to (re)start their projects early in 2012 which is necessary given the tight REACH deadlines of 2013.

The initiative comprises a series of products and services which have been packaged together in a one-time promotional ‘bundle’ to create a comprehensive, distance learning, support package for SMEs in the industry. The one-time price for the whole package is €1155 and is available to companies worldwide for a limited time only, expiring in mid-February 2012.

Be aware! The promotional package ends in 22 days!

The unique package (the ‘Bundle’) is described in detail here.

Read the press release

LET’S FOCUS ON: Letter of Access – what it is and how does it work

ECHA, the European Chemicals Agency, organises a “Lead Registrant Workshop” on 2-3 February 2012 in Helsinki. The workshop is targeted to (new) lead registrants and Mark Meesters, our ReachCentrum Support Services Manager, will be speaking on day two, about the “electronic selling of Letter of Access”, our so-called LoA shop.

But do you know what a Letter of Access is? Mark Meesters will explain us in this issue the purpose of a letter of access and how our service works.

The REACH regulation does not make provisions in regards to the Letter of Access concept. However, Article 10(a) of the REACH Regulation includes: “Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (vi) and (vii) for the purpose of registration”. Therefore we can assume that the LoA can be used to serve this purpose as proof of the right to refer. The registrant makes a statement that he has permission to refer via a LoA in IUCLID5.

The concept ‘Letter of Access’ (LoA) entails two main types/ principles:

• LoA granting permission to use/ refer to studies
• LoA granting right to refer to the entire Joint Submission for a certain tonnage band

In a nutshell, the Letter of Access ensure the access to REACH registration dossiers including access to data in chemical safety reports. The LoA serves as proof (see article 10 REACH) for enforcement authorities.

The signature of the SIEF agreement by a SIEF member cannot act as a proof of the legitimate possession or permission to refer. The SIEF agreement and the LoA do not substitute each other but are complementary. Their combination is recommended. The SIEF agreement contains rules agreed upon in the SIEF, while the LoA summarizes the access rights.

What about the price of the Letter of Access?
The price of a Letter of Access is determined by two factors:

1. Costs to prepare the registration dossier
2. Number of companies sharing the costs

The first factor is built up of various cost items, e.g. testing costs, dossier writing costs (like IUCLID and CSR), administrative costs, etc.). The Lead Registrant or Consortium needs to document all these costs in a transparent system. The second factor is determined by the number of companies that want to register the substance for the various tonnage bands. The costs are normally shared equally, but taking into account to the data needs a registrant has in a certain tonnage band.

Why an automate system?
In order to be able to not only answer theoretical questions relating to access to the dossiers but also meet the needs of our customers in a practical way, in 2010 ReachCentrum launched its “Letter of Access Module”. This tool automates the task of sending invoices, collect payments and subsequently delivering Letters of Access to the SIEF members, avoiding delays to token deliveries and cutting down incorrect payments, making the whole process smooth and cost efficient.

How does the system work?
Via a digital invoice system, buying access to a registration dossier and the corresponding delivery of the Letter of Access is ensured in a secure and transparent way. The seller (Lead Registrant/ Sief Leadership Team/Consortium) provides certain information to set up the system for the sale of a LoA, like the REACH IT xml file containing contacts of all pre-registrants, the price for a LoA, the SIEF agreement (if electronically signed), the Token number of the joint submission and accompanying documents if applicable (IUCLID, CSR).

Once the system is set up for a certain substance the registrant can login, using his UU-ID and create an account. Depending on the process chosen by the Lead Registrant, first signed SIEF agreements are collected and then the price is determined or the price is already available and the LoA can be purchased in one go. Often more SIEF registrants show up than expected, in which case the Lead Registrant reimburses excess of cost shares received to the registrants.

The graph below gives an overview of this process:

Is the Letter of Access process valid for lower tonnage bands? What will be the difference with the first 2010 registration?
The system is set up to deal with all tonnage bands, hence in almost all cases the system contains the prices of Letters of Access for the various tonnage bands as determined by the Lead Registrant. In theory a registrant could already buy a LoA now and register in 2012, with a tonnage band of 1-10 t/a (and not in 2018 which in most cases would be the applicable timing).

The difference with lower tonnage band Letters of Access is only the price. Normally the price for a Letter of Access in a lower tonnage band is less, because the data requirements are less. When calculating the price for a lower tonnage band Letter of Access the Lead Registrants takes this into account already.

Further information on how the LoA shop works can be found here. Have also a look at our demos:

Part 1 – How to sign up http://reachcentrun.emea.acrobat.com/p79871725/ Part 2 – How to purchase a Letter of Access http://reachcentrun.emea.acrobat.com/p12553993/
Part 3 – Letter of Access – the commitment http://reachcentrun.emea.acrobat.com/p39017700/

Lead Registrant Workshop organised by ECHA

This gallery contains 1 photos.

ECHA, the European Chemicals Agency, organises a “Lead Registrant Workshop” on 2-3 February 2012 in Helsinki. The workshop is targeted to (new) lead registrants and will take place in ECHA’s conference centre. Mark Meesters, our ReachCentrum Support Services Manager, will be speaking … Continue reading →

Hello world!

Welcome to our new ReachCentrum’s blog.

You will find here information about the chemical world and latest news in view of the forthcoming 2013 REACH deadline. ReachCentrum, thanks to its overall series of services, will accompany you throughout the entire REACH process.

Stay tuned and up to date with us!

The ReachCentrum team