Chemical Watch Expo 2017 Guide

Chemical Watch Expo 2017 Guide 25-26 April 2017 Berlin, Germany

Sponsored by:

Supported by: 1

Product safety news and resources Chemical Risk Manager is an online publication designed specifically to support professionals managing the risk of chemicals in the workplace, through the supply chain, and in products. It delivers news and resources to help them with practical challenges in their day-to-day roles.

CW ad

Benefits to you

A time-efficient, cost-effective way of keeping up with new tools and guidance as well as new products and services Brings together in one place information that is essential to your team

TOPICS COVERED

Hazard

Exposure

Risk

Tox, ecotox, environmental fate, physchem resources

Resources for modelling, measurement and monitoring

Resources for assessment and characterisation

Data Submission Resources on regulatory data requirements

Customers

Workers

Suppliers

Resources for managing chemicals in articles

Resources on occupational hygiene

Resources for safe use communication

START YOUR FREE TRIAL 2

www.chemicalwatch.com/crmhub

Welcome to REACH into the Future The first Chemical Watch and Chemical Risk Manager Expo Companies facing REACH for the first time might think ‘why?’ Why spend so much time, money and effort assessing the safety of substances that are already in commerce – many of them having been used in industry and by consumers for decades?

The answer might best be found if you look outside of the Regulation itself. Companies can only hope to manage the safety of chemicals through supply chains responsibly if they know the hazard properties of substances, the details of their use and how exposures might occur.

That might be obvious, but many companies would have struggled to answer these questions before the introduction of REACH in 2007.

Expanding knowledge on chemicals is also a tenet we follow as we go about our work at Chemical Watch and Chemical Risk Manager.

Our vision is to provide the global business community with the information and perspectives it needs to achieve safer chemicals in products.

she said. Better knowledge of a substance’s hazard properties should drive innovation as companies develop chemicals that are intrinsically safer, or find other options to manage risks. They will also be able to support customers who are looking for safer chemicals in products.

There are more than 20 exhibitors present at the Expo, including: • regulatory compliance consultants; • data and information providers; • test houses; • the German Federal Institute for Occupational Safety and Health (Baua) helpdesk; and • Echa, which has experts on hand to answer questions, as well as demonstrate REACH-IT and other software tools.

There are also four workshop streams: • stream 1 is designed for beginners;

Leading advisors and service providers And so, it is our great pleasure to have organised our first Expo, called REACH into the future, which brings together and showcases the leading advisors and service providers in the field. We aim to help companies, especially SMEs, with preparations for the REACH 2018 registration deadline. And we are also keen to see that work done well so it can support better chemicals management in the future.

The REACH Regulation aims to improve protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry.

The statistics around the registration part of REACH illustrate the size of the task. For the final 31 May 2018 deadline the European Chemicals Agency (Echa) is expecting around 60,000 registrations for as many as 25,000 substances. The first two REACH deadlines – in 2010 and 2013 – provided safe use information on 15,000 substances.

Next year’s deadline presents many new challenges. The number of registrations is expected to be nearly three times greater than for the previous deadlines. Many more registrants are expected to be inexperienced, not within the chemical sector, and from SMEs.

Companies take the burden of proof

• stream 2 is for those with more experience of REACH and offers case studies and lessons learned since 2012/2013; • stream 3 is devoted to REACH IT and will be presented by Echa representatives and consultants; and • stream 4 focuses on other REACH-related issues, including supply chain communication tools for formulators, automated read-across, challenging chemical safety reports and higher tier assessments, building an appeal case, and developments in other countries such as China, South Korea, Turkey and the US. In addition, we’ve organised for a plenary presentation from Andrew Fasey, a member of Echa’s independent Board of Appeal. The board is responsible for deciding appeal cases lodged against agency decisions made. So far 90 such cases have been brought to the BoA – and it has reached decisions on nearly 80, thus providing a rich source of information on application of the law.

Take a good look at this guide to plan your two days to ensure you get the most out of the event. Also, be sure to provide any feedback on the forms handed out by Chemical Watch staff. We will use this to help us develop future events.

Welcome from the Chemical Watch and Chemical Risk Manager team

By placing responsibility with companies, REACH is systematically generating relevant information on hazards, uses and exposures, and risks of all chemicals on the market in volumes over 1 tonne/year.

After 2018 registrations this information should be available for 40,000 substances. Before REACH, only a couple of hundred substances had been risk assessed in Europe by member state authorities. So REACH has brought a sea-change in knowledge of chemicals, enabling risks to be identified and then managed.

Speaking recently at a Chemical Watch event, Christel Musset also urged companies to see beyond the processes of REACH, and use the information generated to enhance their product stewardship efforts. Companies should see their registration dossiers as an asset,

10 years of informing businesses globally on product safety

10 years of informing businesses globally on product safety

3

Our services for your products       

Safety Data Sheet compilation Classification & Labelling (GHS/CLP) Hazardous substances Dangerous goods classification Downstream user compliance Article obligations consulting Product notifications

productsafety@knoell.com

www.knoellconsult.com

kno-1603-007_az_product safety A5_rz.indd 1

19.10.16 13:32

Sphera has been helping industry leaders achieve excellence in product compliance for over 25 years.

Where are you looking to drive improvements?

Comply with REACH and GHS Automate the creation and distribution of Safety Data Sheets in 46 languages to global markets Leverage global managed content: + 15,000 Regulatory Phrases and Translations + 7,500 Compliance Rules + 300,000 Chemicals & Properties Data Simplify data management and production of SDS Documentation and labeling Streamline chemical management from end-to-end

4

Advancing Product Compliance through innovation, information & insights. ®2017 Sphera. All Rights Reserved.

Improve insight for product classifications and regulatory impacts on your product portfolio Access a team of Regulatory Experts to complement your in-house resources

spherasolutions.com Sphera Solutions, formerly the Operational Excellence & risk Management division of IHS, is now the largest global provider of software and information services in EHS

Contents

Chemical Watch Expo 2017

Programme – pages 6-9 Workshop stream 1:

First steps to REACH registration – page 11 Workshop stream 2:

Advanced themes of registration – page 13 Workshop stream 3:

IT solutions for REACH registration – page 15 Floor plan – pages 16-17 Exhibitor profiles – 18-25

ONE YEAR TO REACH 2018 • • • • •

Registration dossiers with a global mindset Alternative approaches to data gap filling Grouping, QSAR and read-across IUCLID dossiers Chemical Safety Reports (CSR)

Worldwide chemical registrations Visit us at : tox.dhigroup.com DHI Agern5Allé 5 DK-2970 Hørsholm Denmark

Day 1: 25 April 2017 - 09:00 Expo opens 10:30 Coffee break and plenary session: The ECHA Board of Appeal Andrew Fasey, Technically Qualified Member of the Board of Appeal, European Chemicals Agency, Finland Workshop stream 1:

Workshop stream 2:

Beginners’ Session - München Room 1-2

Advanced Session - München Room 3-4

Session 1 - Introduction

Session 1 - Lessons learned from 2012/2013

11:00 REACH overview - why, what’s the objective?

Understanding the jargon

11:00 Case Study: Only representatives duties and chemical importation and inspections

Istvan Mak, Dossier Submission & PIC Unit, ECHA, Finland 11:45 What is your role? Why it’s important to play it fully and engage • Manufacturer, importer, downstream users • Formulator, trader, packer, agent?

• Non-EU, ORs Frederik Johanson, Partner-Sales, REACHLaw, Finland 12:30 Substances, know your portfolio - making an inventory and checking how they need to be registered, eg are they intermediates, or exempt Maria O´Shea, Regulatory and Scientific Consultant REACH, Chementors, Finland 13:15 General Q&A Session

Jose V. Cantavella Cabado, Attorney at Law, Head of Legal Dept., ChemSafe SrL, Italy 11:45 Changes since 2013 Anne Bergner, SCC-GmbH 12:30 New provisions in Data sharing Thomas Delille, Associate, Mayer Brown, Belgium 13:15 General Q&A Session 13:30 Lunch

Session 2 - Testing strategies 14:30 Testing strategies (1) Substance characterisation for REACH

13:30 Lunch

Session 2 - First steps 14:30 Getting help. HelpNet, trade associations/ consortia, consultants. Tips in selecting a partner. What questions to ask, contracts, schedules, deadlines. Keeping on course.

What to do if things go wrong.

Dr Simon Oberholzer, Director: Germany, Switzerland & Austria, Lisam 15:00 Finding co-registrants, Siefs managing the process Anna Forsgren, Manager Chemical Advisors, Intertek Semko AB 15:30 Data needs: Understanding hazard and risk assessment for REACH (dossier is one thing… but know it is the basis for further scrutiny, eg. substance evaluation, authorisation) Dr Neil Hunt, Senior Regulatory Scientist, The Reach Centre, Chemical Assessment Team, UK 16:00 What will it cost - managing costs and minimising them. SME strategies. Data-sharing paying for what you need Claudio Mereu, Partner, Field Fisher, Belgium 6

Dr Emma Miller, Scientific and Analytical Services, The REACH Centre, UK 15:15 Testing strategies (2) For lead registration including data gap assessment, intelligent testing strategies and endpoint fulfillment options Dr Remi Vacherot, Regulatory Toxicologist, The REACH Centre, Chemical Assessment Team, UK 16:00 The role of the CRO on the horizon 2025: How the CRO can bring proactive approaches regarding tomorrow’s issues Celia Cavaignac, International Sales Manager Damien Baudiffier, Ecotoxicologist and RRCo Normative and Regulatory Surveillance Manager, RRCo - Rovaltain Research Company

Chemical Watch Expo 2017

@chemicalwatch #CWExpo2017

Workshop stream 3:

Workshop stream 4:

REACH IT - Hannover Room

Other REACH-related issues - Hamburg 2-3

11:00 Chesar in practice

11:00 REACHING forward: A look at SUMI, LCID and ESCOM-XDML

To get the most out of it we recommend you to bring your laptop. Please download Chesar desktop version beforehand from https://chesar.echa.europa.eu

In this presentation, we will take a look at the future for formulators and how they will need to communicate the Exposure Scenario information to their customers as well as how information may be transmitted through the use of ESCOM-XML

Dr Roberta Bernasconi, Scientific Officer, Computational Assessment & Dissemination Unit, ECHA, Finland

Aad van Keulen, Product Compliance Solution Specialist, Sphera Solutions

13:30 Lunch

11:45 Automated Read-Across for REACH

14:30 IUCLID 6:

This session will provide an update on the collaboration between UL and researchers from John Hopkins University on an automated read-across tool for REACH. We will discuss how this in silico tool will help to minimize animal consumption and will predict toxicity to fill data gaps for the REACH registration process

• Dossier preparation, • Dossier creation, • Validation Assistant plug-in To get the most out of it we recommend you to bring your laptop. Please download IUCLID desktop version beforehand from https://iuclid6.echa.europa.eu

Sandra Esteves Murras, Dossier Submission & PIC Unit, ECHA, Finland Tommy Hagg, Product Manager - ECHA IT Tools, Computational Assessment & Dissemination Unit, ECHA, Finland

Look out for practical demonstrations happening at exhibitor stands throughout the Expo, and discuss individual concerns or issues with on hand experts.

Anne Bonhoff, UL Environment 12:30 Challenging CSRs and Higher Tier Assessment Emma Grange, Senior Consultant, Risk Assessment, Enviresearch 13:30 Lunch

The ECHA Board of Appeal 14:00 How to build a case for an appeal under REACH • ECHA Board of Appeal: introduction (structure and procedure) • Can the decisions of the Board of Appeal be further challenged?

Ruxandra Cana, Partner, Steptoe & Johnson LLP, Belgium

Darren Abrahams, Partner, Steptoe & Johnson LLP, Belgium

16:30 Close of workshops / 17:00 Close of Expo Day 1 - Cocktail reception 7

Day 2: 26 April 2017 - 09:00 Expo opens

Workshop stream 1:

Workshop stream 2:

Beginners’ Session - München Room 1-2

Advanced Session - München Room 3-4

Session 3 - Practical steps

Session 3 - Portfolio management and other REACH issues

10:30 Substance identification and how to report it in IUCLID

10:30 Portfolio management (1) • Organisation and administrative challenges resulting from REACH

Dr Laszlo Majoros, Scientific Officer, Substance Identification and Data Sharing Unit, ECHA, Finland

• How clients have been handling the increased regulatory workload

11:45 What next - dossier completeness check, dossier evaluation (Echa’s strategy), substance evaluation, authorisation, updates Marko Susnik, Senior Advisor, Austrian Federal Economic Chamber - Wirtschaftskammer Österreich, Austria 12:30 Q&A Session

• How implementing digital tools can help Ankur Saxena, Director of Business & Product Development, Euphor 11:15 Case Study: SVHC management with the DEKRA “Product Chem Risk” tool

13:00 Lunch 14:00 SME Case study Lars Dobbertin C.S.B., Gmbh, Germany 14:45 Performing due diligence for REACH • EU REACH Focus - from Candidates List (SVHC) to Authorization List (Annex-14) to Restriction List (Annex 17) • Due diligence - data collection, data validation, and data conversation for product level roll-up • Compliance software and tools - quick view on components that are in violation of REACH and generation of product level REACH reports, and easy assessment of compliance status on future SVHC or Annex-14 list

12:00 Q&A Session 13:00 Lunch 14:00 Integrating REACH compliance with global compliance

• How REACH compliance initiatives can be optimized by taking a more proactive approach to the management of chemical substances • How best to obtain information required to support conformance

15:30 Q&A Session

@chemicalwatch #CWExpo2017 www.chemicalwatch.com/linkedin

8

Dr Michael Cleuvers, Managing Director, Industrial Chemicals & Biocides, Knoell, Germany

15:30 Optimizing REACH compliance: Best practices in proactive chemical substances management

Larry Yen, Green Soft Tech

Let's connect

Jochen Dettke, Product Manager Chemical Regulatory Compliance & Product Sustainability, DEKRA Assurance Services GmbH

• Benefits of conducting a feasibility assessment to determine the ease of REACH compliance

Nadeem Butt, 3E company

Chemical Watch Expo 2017

@chemicalwatch #CWExpo2017

Workshop stream 3:

Workshop stream 4:

REACH IT - Hannover Room

Other REACH-related issues - Hamburg 2-3

Session 3 - S ubmitting member dossiers directly in REACH-IT

10:30 Current status and future of chemicals management in Turkey • Turkish Chemicals regulations in force today

10:30 Submitting member dossiers directly in REACH-IT

• Implementation of EU REACH in Turkey • Overview of Turkish REACH KKDİK Regulation

Terhi Rantala, Scientific Officer, Dossier Submission & PIC Unit, European Chemicals Agency, Finland

• Challenges for companies putting products into the Turkish market

13:00 Lunch

14:00 Cost reduction in REACH: Alternatives to testing The standard endpoints required for REACH registrations are often met by performing the relevant OECD tests in a laboratory. However, there are often other options available that may help to reduce the cost of the registration. These include data waivers, the use of read-across and QSARs. This presentation will provide some background to the available alternatives and their pros and cons. It will also provide some advice about what to look for when reviewing a testing proposal from a CRO.

Dr. Yaprak Yuzak KUCUKVAR Manager, RGS Turkey

11:15 REACH’s consequences in the rest of the world: an overview of how REACH is spreading globally • South Korea • China • USA

Christine Lepisto, UL

12:00 Q&A Session 13:00 Lunch

Peter Jenkinson , Managing Director, CEHTRA SAS

14:45 Read-Across or QSARs? Which one to apply and when?

This talk will primarily focus on providing an overview of the two most commonly applied in silico alternatives, namely Read-Across and QSARs to replace experimental studies (in vivo/in vitro) for regulatory endpoints.

Several commonly used Read-Across and QSAR tools will be discussed. For each tool, an overview of its working principle and methodology will be provided and the model performance will be evaluated using multiple case studies. The advantages and disadvantages of the tools and their relevance for regulatory purposes will be discussed.

As both of these in silico approaches appear to be similar to the uninitiated, the presenter will also provide some useful tips with some example scenarios to decide whether to apply Read-Across or QSARs for a given situation.

14.00 Worldwide regulatory compliance: an overview on GHS implementations in the world

Dr. Ettore Gislon, EHS Regulatory Expert, Selerant srl

Faizan Sahigara, QSAR Expert, Kreatis SAS

16:00 Close of Expo 9

WITHIN AND BEYOND REACH Chemwatch is unique in providing; Expertise, Data and Software-as-a-Service (SaaS) for chemicals management integrated within a modular Software Platform.

Our software and services bring together: CHEMWATCH INTEGRATED SOFTWARE INCLUDES:

EH&S DATA & TOOLS

REGULATORY, SUPPLY CHAIN AND PRODUCT LIFE-CYCLE MANAGEMENT

APPROVAL WORKFLOW SUPPORT FOR YOUR ORGANIZATIONAL STRUCTURES, PROCESSES AND PROCEDURES

•

SDS authoring tools linked to regulatory data

•

Chemical classification module linked to label template gallery

•

Job risk-assessment, for multiple products used simultaneously

•

SDS management

•

Chemical label design software

•

Inventory management (Bar-code & Tablet support)

•

Library boasting 35,000 phrases in 47 languages

•

Regulatory data for 900,000+ chemicals; 6,000 lists, 8,000 chemical families

Stand 1 | chemwatch.net | info@chemwatch.net

Fieldfisher is a full service European law firm advising international clients on large and complex regulatory matters.

With five partners and ten professionals in Brussels, Fieldfisher’s EU Regulatory Group is one of the largest fully dedicated EU regulatory team and is the only team combining advisory, consortia management and litigation work on REACH, pesticides and biocides both at the EU and national levels thereby constituting the go-to firm for product defence.

We advise and represent clients on matters arising under several areas of EU products legislation, including general product safety and eco-design requirements, and more broadly EU market access legislation.

10

Fieldfisher is supporting companies in REACH activities with the aim of: • • • • • •

complying with REACH and CLP requirements; setting up and managing consortia including data sharing discussions and letters of access; communicating effectively with ECHA, Member States and SIEF members; preparing submissions to ECHA and MSCA; coordinating comments on draft decisions and updating dossier or submit further testing proposals; legal assistance in challenging ECHA decisions before the Board of Appeal concerning dossier evaluation, substance evaluation, new data requests and data sharing disputes.

Claudio Mereu

Koen Van Maldegem

Partner Tel: +32 (02) 742 7060 Email: claudio.mereu@fieldfisher.com

Partner Tel: +32 (02) 742 7062 Email: koen.vanmaldegem@fieldfisher.com

Atten d in Mü the wor k nche n roo shops ms 1 -2

Workshop stream 1

First steps to REACH registration The 2018 REACH deadline will be challenging: nearly three times the number of registrations are expected than for the previous deadlines in 2010 and 2013; many more registrants will be first timers, from outside the chemical sector, and small and mediumsized enterprises (SMEs).

Echa has set up a 2018 webpage with resources to help those new to the process. It includes a seven step process to registration, explaining who has to register and where to start.

In addition, every EU member state has set up a helpdesk to respond to questions from companies. A list of the helpdesks can be found on the agency’s website too. Trade associations and industry consortia also provide extensive support.

Joint registration and Siefs Under REACH there is an obligation to share the data needed for a registration dossier. This helps reduce animal testing, and minimise costs. It is done through a mechanism called substance information exchange fora (Siefs).

Siefs are made up of companies with an interest in the same chemical; so the first steps are finding co-registrants and agreeing that you all have the same substance. On Echa’s website there are tools to help companies do this. The 2018 Siefs are expected to be small and many companies may find they are the only registrant.

One lesson learned from previous deadlines is the need to be clear on your substance identity. This can be tricky; many companies working to previous registration deadlines found they were in the wrong Sief.

General principles of identifying substances are described in section 5 of the Guidance for identification and naming of substances under REACH and CLP. It deals with both well-defined substances, and gives information on when two UVCB substances (those of unknown or variable composition, complex reaction products or biological materials) can be registered together. Some industry groups have also provided advice on substance identity and ‘sameness’ and Echa provides some sector-specific support.

For the 2018 deadline, an early step is also to find out if a substance has already been registered for the two previous deadlines. This can be done by checking Echa’s database. If it has a Sief will already exist, and you’ll be able to find the names of lead registrant in a list provided by the agency.

If no registration exists for your substance already, you will have to find out if other companies are planning to submit a dossier for it.

This is done through REACH-IT which contains pre-Sief pages for all substances and their associated companies. It is based on information gathered during pre-registration.

If no other companies pre-registered the substance, you are on your own. It is thought that this will be the case for many preparing for the 2018.

physico-chemical properties, toxicity and ecotoxicity.

It is required for all substances subject to registration; and • a chemical safety report (CSR), which is based on the assessment of the conditions of use under which the risks are controlled.

It is required for substances made or imported in quantities of 10tonnes/year or more.

For substances registered in quantities between 1-10 tonnes/year, the technical dossier also contains exposure related information, such as main use categories, types of use, significant routes of exposure.

The exact information requirements depend on the tonnages made or imported each year, and for substances below 100tonnes/year are outlined in Annexes VI, VII and VIII or the Regulation.

Companies buying access to registration data should only pay for the information relevant to their tonnage band.

Avoiding animal testing is an important consideration. Any vertebrate tests that have to be conducted will need Echa approval, obtained by submitting a testing proposal.

Less data is available for substances being registered in 2018.

Even though there are reduced data requirements for registrations below 100tonnes/year, there is still going to be a considerable need to generate data within the companies making registrations.

It is also important to understand that registration is not just a form filling exercise. The test data and information included in registration dossiers is reviewed by the agency, both manually and automatically, to identify risks that might need further regulatory attention. Including inaccurate use information, for example, could lead to your substance being scrutinised for evaluation under REACH. Companies dealing with substances subject to REACH authorisation have also had problems because of inaccurate data in their registration dossiers.

Speaking at a recent Chemical Watch conference, Echa’s registration director, Christel Musset said registrants should: • be clear on the supported uses, and uses advised against, and the tonnage per use; • clarify substance identify, providing more information than the CAS number; and • provide robust justifications for qualitative or quantitative structureactivity relationship (Qsars), read-across or category approaches.

Echa 2018: www.echa.europa.eu/reach-2018 Helpnet: www.echa.europa.eu/about-us/partners-and-networks/helpnet Cefic: www.cefic.org/Industry-support/Implementing-reach/ Service Providers Guide: www.chemicalwatch.com/REACH_services

The registration dossier – data needs There are two parts to a registration dossier: • a technical dossier, containing information on the substance, its manufacture and use, its classification, guidance on safe use, and robust study summaries that provide information on the

11

ReFaC’s team of regulatory professionals can assist your company – in complete confidence – through a wide range of cost-effective REACH solutions and a portfolio of compliance solutions, including...

Consortium & SIEF management

SDS and eSDS development

Data gap analysis and registration strategy

Supply chain management

Preparation of lead and joint registration dossiers

CLP compliance management Exposure assessment

www.refac.eu +44 (0) 1270 258530 12

Workshop stream 2

Advanced themes of registration Many lessons have been learned based on the first two REACH registration deadlines. The recommendations included in Echa’s annual evaluation report are useful for those compiling new dossiers.

In the latest report, published at the end of February, the agency said that companies should: • ensure exposure assessment and risk characterisation cover all hazards. Such assessments must be carried out for substances made or imported in quantities of more than 10tonnes/year that are in the scope of REACH and meet the hazard classification criteria; • understand the requirements for skin corrosion/irritation, serious eye damage or eye irritation, acute dermal toxicity and skin sensitisation; and • prepare in good time for the 2018 deadline to understand requirements, get organised with co-registrants, and determine if data needs to be generated.

As well as learning from past experience, registrants should be aware of changes in the regulatory requirements.

New data-sharing provisions These changes include new data-sharing provisions, which were adopted in a European Commission implementing Regulation on joint submission and data-sharing. The agency released guidance earlier this year to reflect the new rules. These look closely at cost-sharing mechanisms, joint submission obligations, cooperation agreements and disputes Echa also offers the following practical advice on data-sharing on its website: • • • • • • • • •

ask for the price of data you need; make sure you only pay for the data you need; clarify what you get for your money; request a cost breakdown; analyse the cost breakdown; make sure you only pay the appropriate administrative costs; discuss the reimbursement scheme; request information on the method used for calculating cost; find an agreement on future costs; and

• discuss the payment methods.

Defaulting to non-animal testing The REACH annexes (VII-X) list what data is needed to meet the standard physico-chemical, toxicological and ecotoxicological information required for REACH registration. Annex XI sets out additional rules that provide options for avoiding testing of a substance because its properties can be extrapolated from: • existing data, which has not been generated under Good Laboratory Practice, but is nonetheless scientific; • the weight of evidence; • results from valid qualitative or quantitative structure-activity relationship (Qsars) models; • in vitro methods; or • the grouping of similar substances and read-across approach.

As well as reducing the cost of testing, such approaches also minimise animal testing. However, registrants should provide scientific justifications of the use of non-test data in their dossiers, and may be

Atten d in Mü the wor k nche n roo shops ms 3 -4

called to account for their actions if the dossier is evaluated by the agency. Most companies use contract research organisations (CROs) to carry out testing, and, many seek external expert advice on the best testing strategies. However, it is important to understand the basic legal requirements, the pros and cons of different approaches, and what options are available.

The REACH annexes were amended last year to require non-animal tests to be conducted as a default for getting data for skin and eye irritation, acute dermal toxicity, and skin sensitisation.

Registration based on studies conducted in accordance with the previous requirements do not need to be modified. However, when dossiers are updated, they need to follow the new requirements.

Those registrants who, for example, met the previous requirements with an in vivo study do not need to carry out additional in vitro studies, the agency says. However, a justification for not submitting the in vitro study needs to be included when the dossier is updated.

Echa has updated its advice on the use of OECD test guidelines to support the change in REACH requirements for the following hazard endpoints: • skin corrosion/irritation; • serious eye damage/eye irritation; • acute dermal toxicity; and • skin sensitisation.

Further advice on how to use in vitro methods and other alternatives can be found in the updated Chapter R.7a of Echa Guidance on information requirements and chemical safety assessment relating to skin corrosion/irritation, serious eye damage/eye irritation, skin sensitisation and acute toxicity.

The overall guidance on how to use alternatives to animal testing to meet information requirements for REACH registration was updated last year. It built on experience from the previous deadlines.

The update includes the following ‘how to’ advice: • • • • •

avoid unnecessary testing on animals; report data waiving; report weight-of-evidence; use and report Qsars; report in vitro data; and

• report read-across and categories.

Good advice on complying with the registration requirements of REACH can also be gathered from enforcement activities. The Echa enforcement Forum brings together all national bodies working in this area, and early joint projects have focused on registration.

In 2011, it found that 7% of companies inspected were not in compliance with the relevant registration duties of REACH. Some infringements were very basic, though essential, requirements.

Two years later, the Forum said that 5% of inspected substances were non-compliant with registration requirements, and 3% lacked the required registration.

Forum recommended that stakeholder organisations should intensify their support and information on the REACH obligations, especially towards SMEs and only representatives (ORs) – the organisations that non-EU based companies hire to register substances imported into the region.

13

EH&S Solutions

Safety Data Sheets & Labeling Software Selerant is a global company specialized in the development of software solutions that manage regulations, directives and rulings in the EHS (Environment, Health and Safety) and PLM (Product Lifecycle Management) fields.

Safety Data Sheets and labelling creation

Selerant provides software solutions to manage and create Safety Data Sheets and Labelling in compliance with several worldwide GHS implementations and their related languages.

Selerant’s software suite, equipped with a multilingual user interface, • allows hazard calculation according to GHS-based regulations, • automates the process of distribution of generated Safety Data Sheets, • manages further specific documents (e.g. technical data sheet, IFRA certificat etc.), • has functions dedicated to the designing and printing of labels.

Moreover, there is the possibility to manage additional specific product legislations, such as the ones related to Cosmetics Detergents, Flavors and Fragrances.

SDS distribution

ERP integration

Meet us at the stand 24 Selerant Deutschland / Prosisoft Otto-von-Guericke-Ring 3 Eingang D - 65205 Wiesbaden Phone: +49 (0) 6122 7268 550 Fax: +49 (0) 61227268 551 Email: eu-sales@selerant.com ChemicalWatchAd_PRINT.pdf

1

3/20/17

9:08 AM

ChemicalWatch_210x148mm.indd 1

Introducing

27/03/17 13:50

REACHAcross SOFTWARE

TM

ADVANCED AUTOMATION FOR READ-ACROSS

UL is redefining REACH compliance with REACHAcrossTM software, an in silico tool that combines the best aspects of QSAR and read-across approaches to help companies meet regulatory deadlines.

LEARN MORE >>

Featuring more than 100 million chemical structures and sensitivities of 80%, the tool will provide a new approach to REACH compliance.

SEE MORE >>

14 UL and the UL logo are trademarks of UL LLC ©

ulreachacross.com

Stand 13

Workshop stream 3

IT solutions for REACH registration Registration dossiers have to be prepared using the Iuclid software application, which is based on the harmonised templates developed by the OECD. Once a dossier has been created using Iuclid, it has to be submitted to Echa through REACH-IT. Last summer the agency released an updated version of the software, with the aim of streamlining the REACH registration process through new functionality and better usability ahead of the 2018 deadline.

The tool also takes account of changes in the Regulation and aims to improve dossier quality.

It had already updated Iuclid in April 2016. Iuclid 6, is much easier to install on desktop computers. In particular, no additional software is required. Registrants will need to use Iuclid 6 files to submit or update their dossiers.

The high number of low volume chemicals in scope for the 2018 registration deadline is likely to translate into a high number of submissions from lead registrants with no prior experience of REACH. Many of these will be SMEs with limited budgets for regulatory compliance activity, and they could be alone, with no co-registrants for the same substance.

Consequently, while enhancing the support for frequent users, the agency has also tried to improve the usability of REACH-IT for so-called non-frequent users. The primary objective is to simplify and streamline the user experience. It has integrated help into the application and made the user interface more intuitive.

Online dossier creation for registration And REACH-IT now has a simplified process allowing some registrants to build and submit Iuclid 6 registration dossiers entirely online.

Companies can use this if they are: • • • •

a member of a joint submission; reporting standard information requirements; have only one composition; and are relying fully on the hazard information provided by the lead registrant.

Others need to continue to use the standard Iuclid application.

One substance, one registration REACH has always had a 'one substance, one registration' requirement: if a substance is the same as that belonging to another registrant, or group of registrants, a joint registration must be submitted. The idea is to minimise the costs for industry, make best use of the available information and reduce animal testing.

Echa has tightened up its management of the requirement, with changes to REACH-IT to ensure that dossiers for the same substance are not submitted separately.

Specifically, the application will now only allow you to register your substance: • as part of an existing joint registration; or • as a lead registrant, looking to create a new joint registration.

It will, however, allow you to submit data independently of your coregistrants as an 'opt-out’, if, for example, you disagree with them over what should be submitted. Under such circumstances, you would not need to share the cost of the relevant data, but nonetheless you would be part of the same registration.

Atten d the in th e Ha worksho nnov p er ro s om

Plugins The new version also includes changes to the ‘validation assistant’.

This enables users to check their substance datasets and dossiers, before submitting them. This way they can identify and correct any issues that might prevent successful submission. The plugin simulates many of the checks performed by Echa, for example, it can mimic the agency’s automated validation process.

It should be pointed out that the agency is also checking some dossiers manually, and these are obviously not covered by the new tool.

Several other plugins have been developed, including: • an updated report generator, for creating the chemical safety report (CSR); • one that provides a dissemination preview, which shows how the dossier will be published; and • a fee calculator.

Some companies have tens, or even hundreds, of users working on thousands of substances spread across several Iuclid 5 databases.

They are trying to work out how they can shift to using just one Iuclid 6 database in order to take full advantage of the new features.

Of course, it’s a lot of work,” Echa’s Mike Rasenberg says. “But they are really interested in doing it because it will save them time and effort in the long run.”

Chesar 3 has improved functionality Echa’s latest version of its chemical safety assessment and reporting (CSA/CSR) tool, Chesar 3, has an increased scope of the application in terms of the range of substances with which it can be used.

The term ‘complex substance’ encompasses unknown or variable composition substances, complex reaction products and biological materials – collectively known as UVCBs – as well as multiconstituent substances.

Substances that transform have historically presented a problem for CSRs. Bitumen provides a useful example. It has volatile and nonvolatile parts, but only the volatile part represents potential worker exposure. So creating a CSR that treats the substance as one uniform entity is too crude.

To remedy this, Echa has created a new concept, the assessment entity that allows much more transparency. Use of this concept is optional: it is intended for cases requiring such clarification.

Functionalities have also been improved for the assessment of environmental and human health risks. If the user needs to make the same change to several contributing scenarios, for example, they can now edit them all at the same time.

Companies participating in the Chesar and Iuclid 6 sessions at the workshop should bring their laptops, and have downloaded the desktop versions of the two software tools beforehand: • https://chesar.echa.europa.eu • https://iuclid6.echa.europa.eu

15

u

mb Ha

18. ECHA 19. Baua - REACH-CLP-Biozid 20. REACH Centre 21. ECHA 22. ECHA 23. DEKRA 24. Selerant 25. Green Soft Technology 26. SCC 27. GBK GmbH Global Regulatory Compliance

First Floor

18

rg R E AC 2-3: H

19

REACH IT

Hannover:

Buffet

27

20

t

Atrium

Lif

16

Foyer

Lobby

26

21

22

23

Buffet Buffet

24

WC

WC

25

Advanced session

München 3-4:

Beginners’ session

München 1-2:

17

1. Chemwatch 2. CEHTRA 3. Intertek 4. Enviresearch Ltd 5. ReachLaw 6. Rovaltain Research 7. ChemSafe Srl 8. Eurideas Linguistic Services 9. CSB-Online 10. Euphor 11. Chementors 12. 3E Company 13. UL Environment 14. UL / Safeware Quasar 15. Reach Global Services 16. Envigate (ReachSpektrum/EcoMole Ltd) 17. Fieldfisher 28. Lisam Systems 29. DHI

S1. Dr Knoell S2. Sphera

Ground Floor WC

WC

1

28

Foyer

4

2

3

29

16

S1

17

15

Buffet

13

Lobby

Atrium

14

S2

CW Registration

12

Buffet

Berlin

5

11

6

10

9

8

7

Exhibitors

STAND 12

3E Company, a Verisk Analytics business, provides data and information services which enable companies to improve compliance with EH&S requirements such as GHS, REACH, TSCA, and Employee Right-toKnow. We offer SDS authoring and management; regulatory research tools; integrated content; consulting services and more. www.3ecompany.com | info@3ecompany.com

STAND 19

Three regulations – One helpdesk: The REACH-CLP-Biozid helpdesk, established at the Federal Institute for Occupational Safety and Health (BAuA) in Dortmund, is the official German authority helpdesk for manufacturers, importers and users of chemical substances and biocidal products in Germany.

We provide information and guidance in connection with the implementation of REACH, CLP (GHS) and Biocidal Products Regulation. www.reach-clp-biozid-helpdesk.de | reach-clp-biozid@baua.bund.de

STAND 2

CEHTRA offers scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations: from portfolio strategy to the notification of chemicals, from human exposure to site audits.

CEHTRA’s subsidiary KREATiS offers an alternative to experimentation with High-Accuracy QSARs to calculate HSE properties at an advantageous price compared to laboratory studies. www.cehtra.com | cehtra@cehtra.fr

STAND 11

Chementors provides chemical safety services to companies affected by chemical regulations in the European Union and in China. We offer top notch research and expert services to support our customers’ registration tasks. We help you with the whole process starting from data acquisition to preparation of the final registration documentation. www.chementors.eu | jan.nylund@chementors.eu

www.eurideastranslation.com

Eurideas Language Experts We connect you with the World.

Eurideas Language Experts is based in Brussels, the capital of the European Union. We are specialized in chemicals, REACH, biocides, food additives, agrochemicals, cosmetics, pharmaceuticals, other scientific topics, as well as in regulatory affairs related to the registration of chemicals.

We translate: -

SDSs, MSDSs, eSDSs Exposure scenarios Dossiers Chemical Safety Reports Summaries of Product Characteristics (SPCs) Labels Any other documents related to chemicals and the legislation of chemicals

Visit us at our stand!

Contact details: Eurideas Language Experts 18523 Avenue Louise, 1050 Brussels, Belgium Tel: +32 2 808 46 36, +32 2 808 76 25 translation@eurideastranslation.com

STAND 7

CHEMSAFE is one of the best regulatory consultancy companies in Europe for registration of REACH Chemicals, Agrochemicals, Biocides, Cosmetics and Pharmaceutical products. Our team includes a offers the highest level of knowledge regarding legal, chemistry, biology, toxicology, environmental fate, eco-toxicology and regulatory expertise. CHEMSAFE also offers you Task Forces & Consortium Management, OR, TPR and full REACH Dossiers.

STAND 1

www.chemsafe-consulting.com | chemsafe@chemsafe-consulting.com

Chemwatch is unique in providing; Expertise, Data and Software-as-a-Service (SaaS) for chemicals management all integrated within a state-of-the-art Software Platform.

Chemwatch brings together: EH&S data & tools; Regulatory, Supply Chain and Product life-cycle Management; and Approval Workflow. Chemwatch Software includes: SDS authoring; Regulatory data; Risk-assessment; SDS management; Chemical labels; and Inventory management.

STAND 9

www.chemwatch.net | info@chemwatch.net

CSB is a family operated company that was founded in the early 1990s. With our interdisciplinary team consisting of experts ranging from EHS Specialists over Human- and Ecotoxicologists to Technical Specialists for CLP/GHS we offer a large range of services while setting our focus on REACH, BPR and CLP/GHS.

STAND S1

www.csb-online.de | lars.dobbertin@csb-online.de

We are a full service provider in global regulatory affairs for industrial chemicals, agrochemicals, biocides, pharmaceuticals, veterinary medicine and medical devices. Additionally we offer a wide range of services in the field of product safety (eg preparation of (extended) safety data sheets, classification and labelling of substances and mixtures, product compliance). www.knoell.com | info@knoellconsult.com

19

STAND 23

Exhibitors We are a leading global provider of auditing and certification services, specialising in the fields of safety, environment and health. Our expertise covers management systems as well as testing, inspection and certification of a wide range of products, components, medical devices and equipment used in hazardous areas.

STAND 29

www.dekra-insight.com | info-uk@chilworthglobal.com

DHI is a global consulting and research organisation within the fields of water, environment, health and toxicology. With our expertise in risk assessment, chemicals regulation, toxicology and ecotoxicology we help industry make critical decisions about chemical substances and to prepare applicable documentation. In addition, we offer leading-edge IT solutions and a professional laboratory.

STAND 16

STAND 18,21,22

www.tox.dhigroup.com | info@tox.dhigroup.com

20

The European Chemicals Agency (ECHA) implements the EU’s ground-breaking chemicals legislation for the protection of human health and the environment. Our work helps ensure that chemicals are used safely and that the most hazardous ones are substituted by safer alternatives. ECHA was founded in 2007 and is based in Helsinki, Finland. www.echa.europa.eu

ENVIGATE portal represents an innovative approach to seek and found service providers for chemical and follow-up industries. It saves time and resources by matching your request with encoded services and distributing it to providers. Visit ENVIGATE.com and try it for yourself or become a listed service provider. www.envigate.com | support@envigate.com

STAND 4

Enviresearch is a leading consulting company offering comprehensive registration and expert risk assessment services for the chemical industry in Europe and worldwide. We provide full REACH services, from acting on your behalf in data sharing and cost negotiations to IULCID dossier compilation and submission. Visit us at stand 4 to find out more.

STAND 8

www.enviresearch.com | info@enviresearch.com

Eurideas Language Experts is a translation agency specialized in chemicals, REACH, biocides, food additives, agrochemicals, cosmetics, pharmaceuticals, other scientific topics, as well as in regulatory affairs. We have great experience in translating SDSs and other regulatory documents. We translate in more than 50 languages.

STAND 10

www.eurideastranslation.com | translation@eurideastranslation.com

EUPHOR is a cloud-based Global Compliance Management Software designed to help Regulatory Compliance teams confidently manage their substance registrations using a single platform. With features such as configurable dashboards, workflow automation, alert systems, document management and reporting, teams are able to centralize activities and data, resulting in a streamlined process to successfully completing their registration projects.

STAND 17

www.euphoreach.com | info@euphoreach.com

Fieldfisher is a full service European law firm advising international clients on large and complex regulatory matters. Fieldfisher’s EU Regulatory Group in Brussels combines advisory, consortia management and litigation work on REACH, pesticides and biocides both at the EU and national levels. www.fieldfisher.com | marion.meunier@fieldfisher.com

“Typically, compliance teams use a combination of spreadsheets, email-based tools which lack the ease of traceability, automation and collaboration required for successful registrations. EUPHOR provides a platform that combines the operations of compliance management and process and project management.

Having EUPHOR helped us positively rethink how we manage, collaborate and monitor compliance projects.” - CIO, Global Chemical Manufacturing Company

Relax!!! Be Euphoric with Reach… www.euphoreach.com

21

Exhibitors

STAND 27

GBK GmbH Global Regulatory Compliance is an international consulting company focused on environmental, health and safety issues. Medium-sized and DAX-listed companies from all industries appreciate our experience worldwide. The portfolio includes product-Registrations in chemical inventories in Europe, USA and Asia, and the GBK-EMTEL emergency call number for world-wide hazardous goods transport. www.gbk-ingelheim.de | gbk@gbk-ingelheim.de

STAND 25

GreenSoft Technology is a leading provider of RoHS-2, REACH, Conflict Minerals and other regulation environmental compliance data services and software.

GreenSoft’s data services provides compliance data collection and validation for compliance and due diligence reporting. And GreenSoft’s GreenData Manager software provides out-of-the-box compliance management for large and small manufacturers. www.greensofttech.com | sales@greensofttech.com

STAND 3

Intertek is a leading Total Quality Assurance provider to industries worldwide. We provide our customers peace of mind as we offer comprehensive assurance support and solutions for the registration, testing, and documentation requirements of the EU REACH regulation. Supported by our locations in over 100 countries worldwide, Intertek enables companies to achieve REACH regulatory compliance. www.intertek.com/green/chemicals | regulatoryaffairs@intertek.com

STAND 28

With over 1,100 clients worldwide and supported by 14 local offices, Lisam has grown to become the leading provider of Safety Data Sheet Authoring and Distribution software. Lisam`s global EH&S management solution ExESS™ is suitable for all sizes and types of businesses, is highly flexible and can be rapidly deployed in standalone or networked environments. www.lisam.com | info.eu@lisam.com

Mentoring companies to achieve compliance

22

REACH 2018

SDS & CLP

COSMETICS

BIOCIDES

STAND 20

The REACH Centre is a leading international provider of technical and regulatory services, software tools and training for chemicals compliance management. Specific expertise in REACH and its global equivalents, biocides, hazard communication and nanomaterials. Provider of Chemtrac(R) regulatory compliance software helping industry to track, monitor, manage and control their chemicals. www.thereachcentre.com | enquiries@thereachcentre.com

STAND 15

REACH Global Services, headquartered in Brussels, is a professional regulatory consulting company advising clients in the chemicals and allied industries to comply with European Union and Turkish chemicals legislations, and representing hundreds of manufacturers over five continents in their regulatory compliance processes as an OR & RP. www.reach-gs.eu | info@reach-gs.eu

STAND 5

REACHLaw provides global chemical regulatory compliance and product safety services. We ensure global market access for your chemical products and support you with chemical regulations such as EU REACH & CLP, Turkey KKDIK & SEA & GBF, South Korea K-REACH & GHS, China REACH & GHS and much more. www.reachlaw.fi | sales@reachlaw.fi

STAND 6

Rovaltain Research Company is a French contract research organisation specialised in ecotoxicology and environmental fate studies.

With a surface area of more than 6 700 m² of laboratories, climatic rooms dedicated to experiments that may require biosafety level 2 or 3 and the latest generation equipment we can design tailor-made protocol answering to specific requests; we also offer more conventional tests following ISO, ASTM and OECD guidelines. www.rovaltainresearch.com | ccavaignac@rovaltainresearch.com

Delivering EH&S Regulatory Compliance Solutions Let us help you with

GHS, REACH, TSCA and more.

Ariel® WebInsight

Chemical & Cosmetics Regulatory Research Tool

Regulatory Monitoring

ArielLogic

3E Online®—SDS

Food & Flavors Compliance Tool

MSDgen®

SDS & Label Authoring Platform

Regulatory News Alert Service

SDS & Chemical Management Tool 3E Regulatory Consulting

Product Compliance; Global Chemicals Registration, Notification & Reporting; Risk Assessments

CHOOSE 3E COMPANY 3E Company, a Verisk Analytics business, is a global provider of data and information services which enable companies to improve compliance with EH&S regulations and supply chain obligations through the entire lifecycle of chemicals and products. Whether you are a manufacturer, distributor or corporate user of chemical products, 3E can tailor a program specific to the compliance information and management needs of your organization. For more than 25 years we have led the industry in obtaining and managing content, offering unique insights and solutions that enable customers to reduce cost and risk while improving processes across the enterprise and throughout the supply chain.

www.3ecompany.com | info@3ecompany.com North America (USA): +1 760.602.8700 or Toll free: 800.360.3220 APAC (Japan): +81-363880381 EMEA (Denmark): +45-69918473

23

STAND 26

Exhibitors Founded in 1989, SCC has become one of Europe’s largest privately owned and independent consulting companies, focusing on the regulatory needs of global customers. Since 1996, we have been providing international registration services for chemicals, including OR and SIEF support and Task Force / consortium management.

STAND 24

www.scc-gmbh.de | scc@scc-gmbh.de

Selerant is a global company specialized in the development of software solutions that manage regulations, directives and rulings in the EHS (Environment, Health and Safety) and PLM (Product Lifecycle Management) fields. Selerant provides software solutions to manage and create Safety Data Sheets and Labelling in compliance with several worldwide GHS implementations and their related languages.

STAND S2

www.selerant.com | info@selerant.com

Sphera Solutions is the largest, global provider of software and information services in the operational risk, environmental performance and product stewardship markets. For more than 30 years, we have served over 2,500 customers and over one million users in 70 countries optimize workflows and navigate the complex and dynamic global regulatory structure

STAND 13

www.spherasolutions.com | operationalexcellence@spherasolutions.com

UL is redefining REACH compliance with REACHAcross™ software, an in silico tool that combines the best aspects of QSAR and read-across approaches to help companies meet regulatory deadlines.

Featuring more than 100 million chemical structures and sensitivities of 80%, ulreachacross.com will provide a new approach to REACH compliance. www.ulreachacross.com | environment@ul.com

SHAPING YOUR BUSINESS TO SUCCEED BEYOND 2018

OUR SUPPORT

REACH REGISTRATIONS

REACHLaw’s unique compliance solutions help us solve your most pressing chemical regulatory challenges.

As a leading expert in the registration of chemical substances, we ensure that our clients fulfill all the EU REACH registration and authorisation requirements, as well as requirements for regulations outside the EU.

LEAD REGISTRATIONS AUTHORISATION SERVICES GLOBAL NOTIFICATIONS ADVOCACY SERVICES REACHLaw Ltd. HQ: Vänrikinkuja 3 JK 21, FI-02600 Espoo, Finland

24 FINLAND / BELGIUM / TURKEY / INDIA

+358 (0)9 412 3055, sales@reachlaw.fi

www.reachlaw.fi

STAND 14

UL fosters safe living and working conditions for people everywhere through the application of science to solve safety, security and sustainability challenges. The UL Mark engenders trust enabling the safe adoption of innovative new products and technologies. Everyone at UL shares a passion to make the world a safer place. We test, inspect, audit, certify, validate, verify, advise and train and we support these efforts with software solutions for safety and sustainability. To learn more about us, visit UL.com. www.ulscs.com

Info and insight

25

ULATIONes EU REACprHesRenEtaGtiv e Servic

EU Only Re and Training Consultancy

LATION EU COSMblEeTPeICrsSonRSeEGrvUices & PIF Responsi Assistance Preparation

MPLIANCE d O C IK D ) K K H C ( A E R TURKISH ket Access an Services Mar

e tancy Representativ tegy Consul Turkish Only mpliance Stra Co n tio ra st (Pre)-Regi

URKISH COMPLIANCE WITH T NS TIO CHEMICALSeRanEdGNUotLAification

y) Representativ ISH Inventor CICR (TURK P) Services For CL sh ki ur and SEA (T

Your regulatory compliance partner

E U R O P E A N RGS - Belgium Headquarter + 32 (2) 234 77 77

U N I O N

•

T U R K E Y

•

J A P A N

•

C H I N A

•

K O R E A

RGS - Turkey Branch + 90 (212) 454 09 93

info@reach-gs.eu

www.reach-gs.eu

Looking for a service provider? Want to offer your services?

Visit us on 26

Get up to date with chemicals legislation meet ECHA staff on the 1st floor • REACH registration 2018 - where to start • Substance identification - how to get it right • IT tools: REACH-IT, IUCLID, Cloud services for SMEs, Chesar

27

REACH Centre

REACH Your Safety Potential At DEKRA, we provide you with quality, reliable service, unrivalled project support, capability & versatility, with a track record dating back over 90 years.

Why trust anyone else?

28

www.dekra-assurance-services.com

www.chilworth.co.uk

... Expands your horizons ...

French CRO specialised in environmental fate studies and ecotoxicology SUBSTANCES PROPERTIES AND ENVIRONMENTAL FATE

ECOTOXICOLOGY Acute and chronic regulatory studies

MALDI Imaging Macromolecule analysis

Aquatic/terrestrial organisms

Physical-Chemical properties

Spatial repartition of targeted molecule in matrix

GLP guidelines, ISO standard, ASTM...

Biodegradability and Bioaccumulation studies

Organ or plant tissue analysis

GLP guidelines, ISO standard, ASTM...

MESOCOSM STUDIES Dedicated climatic chambers/experimental hall

ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Humidity, temperature and lighting controlled

Development and validation of analytical method

Biosafety level 2 or 3

Biomarker identification

EFFICACY TRIALS Substances and products efficacy assessment Tailor made protocol dedicated to your studies Mode of action characteristics

Organic substances monitoring 29 2 rue RenĂŠ Truhaut, 26300 Alixan, FRANCE - Phone: +33 77 66 33 805

rovaltainresearch.com

Your last chance to make it for REACH 2018 Let us be your guide • Complete REACH solutions (tests / IUCLID / CSR) • International registration services • SIEF and consortia management

MEET US

• OR and trustee support

AT CHEMICAL WATCH EXPO 2017 in Berlin Stand No. 26

SCC_A5quer_ChemReach_210317_final.indd 1

21.03.17 16:0

EHS Audits,

EMTEL®

Safety Advisor

Risk analysis and

Emergency Response

Certification with cfp®

Telephone Number

cfp® is an unique and innovative system providing the capability to inspect and deliver compliant Safety Data Sheets (SDS), Labels & Transport information.

Emergency telephone number for worldwide deliveries of dangerous goods at any time of day, 365 days per year EMTEL® makes it possible to comply with all international standards EMTEL® Emergency telephone number for MSDS/SDS and for shipping documents for dangerous goods

Safety advisor for all modes of transport (road, rail, barge, air, sea) Classification and labelling of substances and preparations Legal and Organizational consulting regarding EHS

International

Training and

TP1 – electronical documents for

EHS Consulting

Workshops

the transport of dangerous goods

Creation and Monitoring of Safety Data Sheets SDS

In-house training or at special locations

Substances- und Productregistration EC, US, China, Japan, Korea

Dangerous Goods Training and training for Dangerous Goods Safety Advisor MSDS/SDS Authoring expert training

30

GBK

GBK GmbH

Global Regulatory Compliance

Through the GBK-TP1 Portal you can easy upload the already generated electronical transport document.

The GBK-EMTEL Emergency telephone number offers you the 24/7/365 access to the electronical transport document for dangerous goods GBK experts gives you professional and comprehensively advices how you can optimize your process.

Königsberger Str. 29 | 55218 Ingelheim am Rhein | Germany Phone +49 6132 982900 gbk@gbk-ingelheim.de | www.gbk-ingelheim.de

The safety of YOUR PRODUCT ... as seen by: Competent Authorities:

The Business:

NGOs:

Downstream Users:

Put the future of your substance in the right hands

You, as an HSE manager, under enormous pressure from all of these stakeholders to deliver high-quality regulatory Lisamare Systems Deutschland GmbH Potsdamer Platz 5 dossiers - CEHTRA has a recognised track record of producing top-quality dossiers DE - 10785 Berlin Germany in a host of regulatory fields: come and talk to us about yours.

www.

.com

E - info.de@lisam.com T - +49 (0)30 555 74797-1

in silico testing in partnership with

www.

.eu

08

Lisam Systems Deutschland GmbH Potsdamer Platz 5 DE - 10785 Berlin Germany E - info.de@lisam.com T - +49 (0)30 555 74797-1

31

GLOBAL LEADERS IN

HEALTH, ENVIRONMENTAL & REGULATORY SERVICES REGULATORY COMPLIANCE Intertek offers comprehensive solutions for REACH Regulation (EC1907/2006) compliance We go beyond testing, inspecting and certifying products; we are a leading Total Quality Assurance provider to industries worldwide. Our assurance services help companies with the dossier preparation process, supply chain communication and ongoing compliance support. We provide a single-source solution for complying with the registration, testing, and documentation requirements of the EU's complex REACH Regulation (EC1907/2006), working directly with the European Chemical Agency (ECHA) and individual EU governments.

FOR MORE INFORMATION +49 711 27311 11 REACH2018@intertek.com

intertek.com/green

Enviresearch exists to provide the best regulatory and risk assesment service in Europe for the global chemical industry.

We work with a wide range of chemical manufacturers and suppliers, from small to medium enterprises through to large-scale industrial manufacturers, to ensure their compliance with all REACH regulatory requirements.

Our services include: Registration strategy Preparation of technical dossiers using IUCLID software Environmental exposure assesments Ecotoxicology and human health assessments Higher-tier exposure modelling and bespoke problem solving Representation in SIEF/Consortiums Data gap analysis and data quality checks Only Representative for non-EU companies Preparation of Chemical Safety Reports and Safety Data Sheets and labelling according to GHS/CLP Come and talk to us at stand 4 to see how we can help you.

32

+44 (0) 191 243 0687 | info@enviresearch.com | www.enviresearch.com Enviresearch Limited, 34 Grainger Park Road, Newcastle upon Tyne, NE4 8RY, UK