The weird call of the week

I have received a fun call Today:

  • Me: what can I do for you?
  • Other: I want to implement Reach on my client. Have you installed Reach on your client?
  • Me: no, I have not done it. What do you mean?
  • Other: someone told me you worked on Reach activities.
  • Me: That’s true. But we have not implemented Reach on the client. We have helped them to adapt its processes and applications in order to be Reach compliance.
  • Other: so isn’t it something published by European Union?
  • Me: Yes, what is published is a set of goals and deliverables that can be done by each company in the way they want.
  • Other: Then, is not Reach an SAP module?
  • Me: no it isn’t.
  • Other: really? Then what is it?

I cannot continue…

At the end, the situation made sense. The customer is a mid-size company who has pre-register all their activities and that now is preparing the processes to arrive to the 10 Tons milestone in 2013.

What is a REACH Only Representative?

A Reach Only Representative is a legal entity established in the EU, nominated by natural or legal persons that manufacture substances, formulate preparations or produce articles outside the EU.

An OR should have sufficient background in the practical handling of substances and the information related to them to be able to fulfil the obligations of importers.

Non-EU company appoints an only representative,

  • Although companies from outside the EU cannot register substances themselves they can appoint an Only Representative.
  • It is important that the OR has the skills, resources and experience to do the job.
  • Companies that import from outside the EU become Downstream Users and need to work with the OR for those chemicals where one is appointed.

This case study is so much interesting:

http://www.hse.gov.uk/reach/casestudies/redflag.htm

Judge people by their feet, not their mouth

3M chief warns Obama over business regulation.

George Buckley, chief executive and chairman of 3M:

“judge people by their feet, not their mouth”

http://www.ft.com/cms/s/0/bd9b4100-429b-11e0-8b34-00144feabdc0.html?referrer_id=yahoofinance&ft_ref=yahoo1&segid=03058#axzz1FFSfnQ3Y

Regulation on the chemical industry is business as usual. Depending of the type of measure, there are companies agreed with those initiatives, there are others than no.

For those they reject to the new conditions first move is threat: we are going to move the company production outside!!

The European Union, knowing this behaviour, based the Reach principles with a basic scope: it applies to the companies that commercialize their products in the EU area. Problem solved. :-)

Danish EPA surveys chemicals in cleaning products

The consequences of the Reach data analysis is starting to have benefits on the European citicens:

The Danish Environmental Protection Agency has published a survey of chemical substances in cleaning products for ovens, cookers and ceramic cooktops. The study determined the ingredients of 21 products and further analysed 14 to measure the level of organic solvents they contained. They also tested four products for the presence of PFOS compounds, but none were found.


The survey concluded that such consumer products do not present a critical health risk to consumers or the environment. However, it did find that some of the products contained organic solvents in concentrations that in certain circumstances may be harmful and therefore the use of such products should be minimised.

Source: http://chemicalwatch.com/6471?rss=news

ECHA Summary of Work Programme 2011

A summary of key objectives for 2011.

ECHA key objectives:

  • First, the Agency needs to publish online the information from REACH registrations and CLP notifi cations. It is an enormous task to make scientifi c information as accessible as possible.
  • Second, ECHA will evaluate the quality of the data of at least 5% of the submitted REACH dossiers and all proposals for testing substances on animals.
  • Third, ECHA will provide two important reports to the European Commission: one on the operation of the REACH regulation which will contain proposals for improving its workability and a second on the status of implementation and use of non-animal test methods and testing strategies.
  • Fourth, is to address chemicals of concern through the authorisation process. As a follow up of the policy initiative of the European Commission, ECHA expects a larger number of Substances of Very High Concern to be added to the candidate and authorisation lists this year.

Manufacturers and importers of substances key objectives:

  • First, submit a registration dossier. Registrants of the same substance must share their data to avoid unnecessary animal testing. The Agency makes the non-confi dential information publicly available.
  • Second, on authorization, to ensure the appropriate control of the most hazardous substances, companies will increasingly need to get prior authorisation for their use.
  • Third, adoption of new proposals for restrictions will be made for the European Commission and, together with new proposals from Member States, submitted to the Risk Assessment Committee. They have to be adopted by the companies.
  • Fourth, companies have to evaluate their chemicals and communicate hazards on the package label. They also have to submit a notifi cation of the classification to ECHA for the public inventory.

Source:

http://echa.europa.eu/doc/work_programme/2011/summary_wp2011_en.pdf

Targeted Risk Assessment (TAR)

Targeted Risk Assessment (TAR), that offers an integrated tool that helps on:

  • Worker Exposure,
  • Consumer Exposure,
  • Environmental Exposure.

I have downloaded the first one (Worker Exposure), it’s an Excel spreadsheet!!

It allows the user to calculate predictions for inhalatory and dermal exposure (Tier 1 level) for the benefit of performing Chemical Safety Assessments.

It’s very easy to use,

  • Open the excel,
  • Allow Macros Execution,
  • Read the “Notes before use” (it takes less than 1 minute, so do it).
  • and go ahead.

You can find the user guide for “Work Exposure” here

You can find more information for TAR tool here

ECETOC, European Centre for Ecotoxicology and toxicology of chemicals

Original information http://www.ecetoc.org/overview

What is ECETOC?

ECETOC is a scientific, non-profit making, non-commercial trade association with a mission to act as an independent, credible, peer-reviewed technical resource to all concerned with the identification of research needs and provision of scientific rationale for the assessment of health effects and environmental impact, and thereby to justify industry’s licence and freedom to operate.

How is it financed?
ECETOC is financed by its membership, which comprises 49 of the leading companies with interests in the manufacture and use of chemicals.

Some companies: AzkoNobel, Arkema, BASF, Bayer, Johnson & Johnson, BP, Cepsa, Ciba, Clariant, Coca Cola, Dow Chemical, DuPont, Exxon mobil, Roche, Henkel, Merck, Nestle, Novartis, Repsol, Shell Chemical, Total…

Full list of member’s companies

Why was it established?
An independent organisation, it was established in 1978 to provide a scientific forum through which the extensive specialist expertise of manufacturers and users could be harnessed to research, review, assess and publish studies on the ecotoxicology and toxicology of chemicals. In pursuing its vision, the Association’s main objective is to identify, evaluate and through such knowledge help industry to minimise any potentially adverse effects on health and the environment that may arise from the manufacture and use of chemicals.

How does ECETOC achieve its goals?
To achieve its goals, ECETOC facilitates the networking of suitably qualified scientists from its member companies and co-operates in a scientific context with intergovernmental agencies, health authorities and professional institutions.
ECETOC’s work is manifested as published reports, papers and specialised workshops. Furthermore, it provides scientific representation of manufacturers and users of chemicals via presentations at specialist fora and takes a scientific role in the activities of international organisations and regulatory groups.

More specifically, ECETOC achieves its goals by:

  • Promoting the use of sound science in both industry and regulatory decision-making and reporting on the results;
  • Providing a forum for regulators, academic and industrial scientists for the evaluation of the safe use of chemicals and their associated products;
  • Contributing to understanding of the societal issues associated with health assessment and environmental safety of substances;
  • Ensuring the value of the ECETOC offer is appreciated by business and regulatory decision makers;
  • Identify emerging issues that are of importance to ECETOC member companies.

Vision
To be the leading European health and environmental sciences organisation enabling the safe manufacture, handling and use of chemicals, biomaterials and pharmaceuticals.

Mission
To promote the use of good science in human and environmental risk assessment of chemicals, biomaterials and pharmaceuticals.

CHESAR, CHEmical Safety Assessment and Reporting tool

Original link http://chesar.echa.europa.eu/home

Chesar is a tool developed by the European Chemicals Agency (ECHA) which aims to help companies carry out their Chemical Safety Assessments (CSA) and prepare their Chemical Safety Reports (CSR).

For this purpose the principles relating to chemical safety assessments as described in the “Guidance on Information Requirements and Chemical Safety Assessment” (available on the ECHA website: http://guidance.echa.europa.eu/guidance_en.htm ) have been converted into an IT application.

Chesar provides the structured workflow for carrying out a standard safety assessment for the different uses of a substance. At the same time, the tool is flexible enough to also accommodate assessments in more specific situations. The tool also helps to structure the information needed for the exposure assessment and risk characterisation which will facilitate the generation and updating of a transparent CSR.

Based on these inputs the tool calculates exposure estimates that are compared to the predicted no-effect levels. The purpose of this comparison is to determine whether safe use of a substance can be established. Workers’ exposure estimations provided by Chesar are calculated using the “ECETOC TRA worker” tool (available on http://www.ecetoc.org/tra ). Environmental exposure estimates provided by Chesar are based on the EUSES 2.1 fate model (see below).

Chesar also supports the use of other exposure estimation tools or measured data (has they defined a way to import data exposure?).

Chesar enables re-use of assessments already carried out by the registrant or prepared by industry associations via its data exchange functionality. This functionality supports cross-industry standardisation of the description of uses and of the safe conditions of use.

Technical data:

  • Chesar works as a plug-in to IUCLID 5.2.
  • CHESAR 1.0 does not yet generate a full CSR or the Exposure Scenarios for the extended Safety Data Sheets.
  • Chesar 1.0 is only available for the stand-alone version of IUCLID 5.2.
  • The first upgrade of Chesar including the full CSR generation functionality and the capacity for use with the distributed version of IUCLID 5.2 is planned to be available in July 2010.

EUSES -> European Union System for the Evaluation of Substances.

Reach roadmap

We have developed an IT solution to manage some business processes to be Reach compliance.

These processes are related to:

  • Substance Volume Tracking, for the calculation of the volumes to be registered by substance,
  • Substance ID management, that allow the chemist guys to establish the % of substance for a raw material,
  • Suppliers communications, that handles the relationship between a supplier and Raw Material. It allows to determine the codes of UEW to be handled.

There are some document management needs for Reach, but they still are a little bit far away. We have the CSAs and CSRs.

  • For CSA, I don’t know where it comes from, but it’s supposed that this assessment is added to the CSR.
  • For CSR, there are some information that comes from the UEW for each substance.
  • It’s not clear how they are managing the UEW activities from the suppliers, so it would be one of the first steps…

In summary, I need to spend some days reading / investigating what is the next immediate need of my client in terms of IT to automate more Reach processes.

Reach: SIEF Lead Registrant


Be a Lead Registrant under Reach means leading all registration process/activity for a given substance.

To take into account:

  • Being Lead means High responsibility but no benefit.
  • A reason to be lead can be presented when they do not trust the others in the same SIEF.
  • When a party is a lead it remains the lead for ever!! It means for instance that if you are the methanol lead, every new importer/manufacturer needs to be guided by the lead.
  • If a participant has the largest volume, this party is just voted to be the lead if there is no one volunteering.
  • A reason to be Lead Registrant? because you own a lot of data and it can make the other to use it.
  • Initially the best option seems to be a dormant participant.

I need to continue investigating,