Chemicals Safety in the Value Chain

How the European Chemical Industry Manages Safe Use of Chemicals

Introduction
How companies address chemicals safety
The basics of chemicals safety
Safety at every stage
- Caring for our employees
- Sourcing and Research & Development
- Process and production
- Ambitious targets
Caring through the value chain
- Transport & distribution
Caring about customers and end users
- Cooperation with downstream users
- Disposal and recycling
Europe’s legal framework
- Production and worker safety regulations
- Classification and labelling – standardisation of hazard communication
- Product safety
Chemicals in the public debate
Look to the future

Introduction

The chemical industry has a long and proven track record of ensuring the safe use and handling of its products, up and down the value chain. Thanks to these efforts, accidents in the production, distribution, use, and disposal of chemicals are rare. And, since safety is of paramount importance to our industry, we are constantly looking to improve upon our achievements to date.

Intended for authorities, interested stakeholders, and an informed public, this publication aims to describe what the industry has been doing, is doing, and will continue to do to ensure its products are handled and used safely at every step. We are fully aware of societal concerns about risks from certain new and existing chemical substances, sometimes calling for special precautionary measures. These are legitimate concerns the chemical industry needs to address. So we would also like in this publication to focus on the public debate surrounding substances of concern, nanomaterials, endocrine disruptors, combination effects, or legacy chemicals. And to explain what industry is doing to ensure robust science is applied when uncertainties are identified.

Based on a life cycle approach, the development of products is subject to regulatory control at every stage. Additional voluntary initiatives from industry are also detailed. These include care for employee programmes and improvement in production processes to enhance safety, health, and the environment. The value chain is also the subject of particular attention, starting with distributors and encompassing customers and end users as well as the disposal and recycling of products.

The European chemical industry is well regulated, with the EU legal framework for chemicals recognised as one of the most advanced worldwide, encompassing safety of workers, information sharing with classification and labelling, registration, and evaluation of chemicals through REACH. In addition, product safety legislation focusing on the most critical products, like food or cosmetics, provides another level of protection where appropriate.

We believe continuous dialogue and transparency should drive our societal choices for improving chemicals safety.

How Companies Address Chemicals Safety

LONG-RANGE RESEARCH INITIATIVE (LRI)

Exposure science is one major research area. Industry’s investment is leveraged through collaborations with publicly-funded projects that maximize project value. The results are published and shared freely with stakeholders. Since 2005, the LRI has sponsored annual workshops on current issues in risk sciences and chemicals management.

KEY PRINCIPLES OF REACH

Ensures a high level of protection of human health and the environment.
Enables free movement of substances in the internal market.
Makes industry responsible for managing chemical risk and providing information to users.
Promotes alternative test methods to animal testing.
Enhances competitiveness and innovation.

RESPONSIBLE CARE

Helps companies to improve their safety, security, health, and environmental performance, to be open and engage with stakeholders. It plays a significant role in the industry’s drive for sustainability and includes products as well as industrial processes.

In 2006 the United Nations Environment Programme (UNEP) adopted the Strategic Approach to International Chemicals Management (SAICM) to promote safe chemicals management around the world. Our industry launched the Responsible Care Global Charter and the Global Product Strategy (GPS) with the aim that by 2020, the industry will have established and communicated hazard and exposure information adequate to conduct safety assessments for chemicals in commerce.

KEY POINTS INCLUDE

In discussions about chemicals, the words ‘risk’ and ‘hazard’ are often used incorrectly, as if interchangeable.
A HAZARD describes the way in which an object or a situation may cause harm. A RISK defines the chance that the hazardous effect will actually occur.
For a risk to materialize, there must be both the hazard and EXPOSURE leading to an adverse effect. Without both at the same time, there is no risk.
Risk can be high or negligible, depending on the likelihood that harm will occur. Risks are all around us in our daily lives: we make judgments, consciously or not, about the hazards involved and assess the risks before taking action whether at home, crossing the road, taking a plane, or driving.
Even if a chemical has hazardous properties, the risk to human health or the environment will be negligible, provided the chemical is handled safely under controlled conditions.
Risk assessment is an important management tool to determine how and in what circumstances a chemical can be used safely.

What about the Precautionary Principle?

Cefic strongly supports the European Commission’s Communication on the precautionary principle of February 2000, which sets out some requirements that are essential to the application of that principle.

“According to the Commission, the precautionary principle may be invoked when a phenomenon, product, or process may have a dangerous effect, identified by a scientific and objective evaluation if this evaluation does not allow the risk to be determined with sufficient certainty.”

The Commission stresses that the precautionary principle may only be invoked in the event of a potential risk, and that it can never justify arbitrary decisions.

The Basics of Chemicals Safety

PRELIMINARY CONDITIONS FOR APPLYING PRECAUTION

Identification of potentially adverse effects
Evaluation of the scientific data available
The extent of scientific uncertainty

FIVE PRINCIPLES TO BE TAKEN INTO ACCOUNT

Proportionality
Non-discrimination
Consistency
Cost/benefit of action or inaction
Review measure

Products are designed, developed, or modified both to meet customer needs and to ensure they are safe during production and intended use. When developing new products, companies identify potential issues at different stages of the production, use, and disposal of substances or formulations. Products on the market are constantly tested, not only by manufacturers but also, for example, by independent scientists, authorities, and consumer associations. When significant new information on hazard or risk becomes available, companies assess it, adapting safety recommendations accordingly or substituting the product.

Safety at Every Stage

CARING FOR OUR EMPLOYEES

Sourcing and Research & Development

Raw materials – the substances used in a chemical production process for modification or transformation – come from fossil-based materials, renewable raw materials, and inorganic minerals.

In line with our drive towards sustainability, companies use a life cycle assessment (LCA) to determine the optimal sourcing strategy in relation to raw materials. Additionally, as LCAs do not assess safety, we assess risk separately.

Research and development contribute to increased knowledge and adaptation of testing requirements, with safety starting at a very early stage of the R&D process and continuing throughout the whole life cycle. High standards for safe working practices in the laboratory help set the bar for all stages of the product lifecycle. As noted by one leading chemical company, ‘analysing the hazards and mitigating the risks are part of designing an experiment. Safety is part of the scientific method.’

Whether sourced in Europe or imported, all companies must ensure that relevant data on a substance are available with details of properties, including hazard information. Suppliers usually provide supplementary data that will be useful to customers, in addition to the information required by law.

TOGETHER FOR SUSTAINABILITY

In order to enhance sustainability within their global supply chains, six multinational chemical companies joined forces in the Together for Sustainability (TfS) initiative. Open in the future to other firms and organizations all over the world, the TfS initiative successfully concluded its first year of piloting supplier sustainability assessments and audits in 2013. TfS aims at developing and implementing a global supplier engagement programme that assesses and improves sustainability sourcing practices, including ecological and social aspects.

Process and Production

Not only must our products be safe to use, they must be made under safe worker conditions. The European chemical industry’s safety record is about twice as good as manufacturing as a whole, because we pay great attention to the safety of our employees and installations. That is our licence to operate.

Ambitious Targets

Many of Cefic’s member companies set ambitious internal goals to improve their health, safety, and environmental performance, reviewing progress against these goals on a regular basis.

IMPROVING SAFETY BY DESIGN

AkzoNobel and its Spanish partner GRIT developed a sustainable technology offering major advances on existing approaches, and addressing occupational health issues surrounding the treatment and preservation methods used by the leather industry. This closed-loop extraction process using liquid dimethyl ether (DME) solvent offers very low toxicity, easy recovery, limited emissions, significant reduction in the use of water and chemicals, low energy consumption, low waste water generation, and valorisation of extracted fat normally considered as waste.

CARING THROUGH THE VALUE CHAIN

Transport & Distribution

The chemical industry fosters close links at company and association levels with its partners in the value chain to help make the transport of goods to and from manufacturing sites and storage locations safe. We have developed successful partnerships at European and national levels under Responsible Care with non-manufacturing sectors, such as transport and distribution. These involve cooperation on the organisation of joint events and the development of guidance materials related to safety, which are regularly reviewed and updated.

SQAS

Industry makes widespread use of a third-party assessment programme for storage, logistics, tank cleaning, and transport providers, Safety and Quality Assessment Systems (SQAS). SQAS assessments are carried out by a European network of accredited independent third-party assessors using a standard questionnaire to ensure consistency. It helps logistics and other service providers to increase their HSE performance by identifying potential areas for improvement. Developed by Cefic, SQAS has been adopted as far afield as China and Brazil. The scheme has been developed for chemical distributors in cooperation with the European Association of Chemical Distributors and for shippers in cooperation with the Chemical Distribution Institute.

CARING ABOUT CUSTOMERS AND END USERS

The chemical industry acknowledges the importance of communication on safety with downstream users. Regulatory requirements ensure hazard information gets to the user or handler. However, the information, often too complex and lengthy, sometimes leaves them none the wiser.

THE ‘KNOW YOUR CUSTOMER’ CAMPAIGN

In close cooperation with the Chemical Industries Association (CIA) and the Chemical Business Association (CBA), the UK National Counter Terrorism Security Office developed the ‘Know Your Customer’ (KYC) campaign. This voluntary scheme is designed to raise awareness within industry about the potential for misuse of chemicals and products used or supplied in the course of legitimate business.

Cooperation with Downstream Users

Depending on the hazard profile of the substance supplied, risk management can range from providing hazard and safe handling information to requiring customers to demonstrate the ability to safely receive, store, and use a product prior to sale.

Key Safety Steps in the Manufacturing, Marketing, and Supply Process

Manufacturer establishes product parameters in order to meet quality requirements, for example different grades of the same chemical (concentration, purity, etc) depending on application
Products are tested to ensure they meet requirements. Normally, a certificate of analysis or conformity accompanies the delivery
Traceability is achieved through a batch number on paperwork or label. Chemicals in pharmaceutical applications need to be manufactured to current good manufacturing practices (cGMP). Ingredients for cosmetics, pesticides, and biocides, and chemicals used in food contact are subject to specific approvals. Other customers may require Kosher and Halal certificates confirming that no substances of specific animal origin were used on the site where the products were manufactured
Documentation usually includes Safety Data Sheets and labelling, and/or product technical data sheets with production process-related information and clear indication for specific uses
Some products may also include information on safe disposal and process safety procedures.

Disposal and Recycling

To avoid dangerous chemicals ending up in landfill or incineration, ESPA, the European Stabiliser Producers Association, is participating in an ambitious programme to develop recycling of PVC articles. ESPA is an active contributor to the PVC’s sustainability programme VinylPlus.

Europe’s Legal Framework

Production and Worker Safety Regulations

Sites that make, use, and store chemicals are subject to stringent regulatory requirements to control emissions to soil, air and water, and waste management. Safety standards for plant design include filters to reduce emissions, separate sewage systems to isolate site water run-offs, and secondary containment around large capacity storage tanks and reactors to ensure that any accidental release of products is totally contained.

Chemicals in the Public Debate

Interview with Peter Smith, Cefic Executive Director in Charge of Product Stewardship

Q: The public are eager to know more about new and highly innovative areas of the chemical industry, but feel kept in the dark as to their benefits and risks. What is the chemical industry doing to develop and disseminate its knowledge in these areas?

As you know, the industry is constantly building on its product knowledge. The combination of voluntary and regulatory programmes has helped us continue to improve the way we share this knowledge through the supply chain to the end user or the general public. Our Responsible Care and Global Product Strategy (GPS) initiatives are contributing to better dissemination of information.

Q: Consumers are naturally concerned about the risks to human health and the environmental behaviour of products they hear about in the media. They see scare stories about certain substances heightening their concerns. How can the scientific community allay consumer fears and bring clarity to the debate?

As I see it, the scientific community has the duty to distinguish between the latest research results and the latest scientific knowledge. They are different. Speaking as a member of the public, I want to know about the latest scientific knowledge. I do not want to know about new hypotheses that will not stand up to subsequent scrutiny or more extensive studies. This is also true for the media. The latest research results might make for a good story, but it’s unlikely to guide my everyday behaviour.

One should always put these results in the right context – something which is achieved, for instance, by the UK Science Media Centre (http://www.sciencemediacentre.org/\).

Q: Some substances, like cadmium, a carcinogen and teratogen, are particularly dangerous, their harmful effects on both health and the environment undisputed. What is being done to protect consumers from these very hazardous substances?

Much is being done. The production and use of Substances of Very High Concern (SVHC) is today subject to demanding safety standards. Europe’s REACH legislation, being implemented since 2007, sets out criteria under which these substances must be identified and prioritized for risk management, including authorisation and restriction. They are the procedures by which uses of substances can be greatly reduced or eliminated altogether.

Q: So in Europe we have REACH, hence tight regulation ensuring safety. But what about all the products imported into the EU whose components are manufactured in countries with lower safety standards?

There are two issues to consider here. The first deals with the safety of EU citizens. REACH and other legislative measures also apply to imported products. So, provided enforcement controls are effective at EU borders, there should be no risks from imports.

Q: Hardly a day goes by without a media scare about an endocrine-disrupting chemical. How would you define such a substance? And is any substance that acts upon the endocrine glands automatically classed as an endocrine disruptor?

Perhaps the best place to start is the internationally agreed WHO definition. It states that endocrine-disrupting chemicals act on the endocrine system in a damaging way. When this happens, health issues ranging from low fertility, abnormal growth, to cancer can arise. And when this is the case, the use of such materials needs to be carefully controlled.

Against this background, you need to consider that the endocrine system is a complex set of glands that regulate hormone levels and receptors in the body. These glands and hormones control or influence functions such as metabolism, blood pressure, growth, and reproduction. Well-known hormones include adrenaline, insulin, oestrogens, and androgens.

Some everyday products such as coffee and soy milk contain natural endocrine-active chemicals which interact with the endocrine system but do no harm. However, some chemical substances, natural or man-made, known as endocrine disruptors, can seriously harm health, causing lower fertility, fetal abnormalities, and cancer.

Q: And what will be done to assess EDCs?

Scientific and regulatory debates are underway to determine how best to identify endocrine-disrupting substances. In the EU, the Commission is developing criteria for this purpose. Once identified, endocrine disruptors will be assessed for their potential to cause harm under realistic conditions. Industry is very much engaged in the discussion and has provided expertise to the debate.

Over the last 20 years, the chemical industry has made significant contributions to basic and applied research on endocrine mechanisms and specific testing. We are keen to establish safeguards for chemicals identified as endocrine disruptors and ensure that the existing regulatory framework manages their safe use.

Look to the Future

The chemical industry plays a major role in providing a high quality of life through sophisticated products. Turning raw materials into chemical substances used in the production of basic consumer goods and selling advanced materials to virtually all manufacturing industries is our daily business.

Supplying products that are safe for their intended uses, combined with excellence in all aspects of chemicals management, is our daily commitment. We want to extend this commitment to safety throughout the value chain, at all stages of a product’s lifecycle.

We build on a comprehensive European and national regulation system as well as on voluntary initiatives, such as Responsible Care, the Global Product Strategy, and the Long-range Research Initiative. We can rely on robust processes to address both new chemicals coming onto the market and existing chemicals, always integrating new knowledge delivered by scientific evidence.

We do not have all the answers, but in the spirit of transparency and dialogue, we will continue to work with our stakeholders and keep safety as our top priority.

We believe in the future of the chemical industry in Europe and its capacity to create wealth and provide high-quality jobs while managing chemicals safely. A thriving and sustainable chemical industry is an essential solution provider to the many challenges facing society today and tomorrow. We know this is not something we can achieve alone: it is fundamental that we continue to work, dialogue and partner with key actors throughout the value chain.

Learn more: www.cefic.org/sustainability

We hope you found this publication informative and would appreciate receiving your feedback.

Contact: safety@cefic.be

Notes

Chemistry – simply essential for a sustainable future
Cefic aisbl
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Tel: +32 2 676 72 11
Fax: +32 2 676 73 00
safety@cefic.be
www.cefic.org
June 2014