- Chemicals legislation in Europe and worldwide is complex and expanding, led by REACH
- (Planned) EU bans and restrictions on chemicals such as ADCA, DEHP, toluene, and formaldehyde pose tough market challenges to tape-related businesses
- Bolstered by Scandinavia, REACH has had the largest impact on European tape businesses, which must keep up with discussions taking place about registered chemicals
- EU legislation will probably soon be developed to cover polymers and ‘articles’
- In order to succeed, adhesive-tape-related organisations will have to adapt efficiently to developing legal requirements by incorporating regulatory affairs into their business models
- Both large companies and SMEs should create dedicated divisions or teams to manage regulatory affairs within their organisations; build a system of compositional data with customers; incorporate regulatory affairs into product development, sustainable development, product procurement, and, especially, sales; provide regulatory support for each global region in which companies are present; and use regulation as a driver for innovation.
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Afera’s Dubrovnik conference presentation series
At Afera’s recent Annual Conference in Dubrovnik, Amy Aerts, Regulatory Affairs Manager at Nitto Europe NV, discussed what European adhesive tape businesses need to know about chemicals regulation today, what they can expect in the near future, and how to manage it within their organisations.
The bottom line: Chemicals legislation in Europe and worldwide is very complex today, including evolving regulations, directives, and commercial standards. Regulatory affairs will only increase in importance going forward as more substances are banned or restricted, and more areas of business are governed. Legislation will probably soon be developed to cover polymers and ‘articles’. In order to succeed, adhesive-tape-related organisations will have to adapt efficiently to developing legal requirements. Most likely large companies already deal with regulatory issues through dedicated departments within their organisations. For SMEs, integrating a division or team into their business poses more of a challenge. There are a number of measures businesses can take to incorporate regulatory affairs into their business models.
A few relevant chemicals
Chemicals regulation, primarily in Europe, has a great impact on business today. Ms. Aerts began her presentation by discussing current and planned European legislation on certain substances used by the tape industry that poses great challenges to the European adhesive tape market:
C,C azodicarbonamide (ADCA) is a blowing agent used to make PVC, PE, PU, and rubber-based products commonly used in the automotive industry. The European Commission (EC) plans to ban ADCA in the European Union. Because of its unique properties, this chemical is challenging to phase out or to replace, posing problems to the European adhesive tape market.
Bis(2-ethylhexyl) phthalate (DEHP) is a plasticiser used in many PVC products. It is likely that PVC commodity products will be shipped out for production in other regions such as Asia. Because it has been banned for use in the EU however, this shift in production will happen much sooner. As phthalates are known to have properties adverse to human health, the US and other countries across the world are also considering legislation on these chemicals.
Toluene is a solvent with a short lifespan. The chemical is used worldwide, and the EU has restricted its use in consumer goods. Formulators everywhere are working on substituting it with greener solutions.
Formaldehyde is present in binders and adhesives especially for wood products and carpeting. Labelled as a known human carcinogen, formaldehyde is on the list of the substances included in the Community Rolling Action Plan (CoRAP) to be evaluated by the Member States in the next three years. It is not clear whether it will be restricted or banned.
What have been the most significant changes in the regulatory environment?
- IMDS:The greatest changes in chemicals regulation started in 2000 with the introduction of the International Material Data System (IMDS), a standard in the automotive industry for OEMs. This web-based system solved the problem that the auto industry had in keeping track of the thousands of articles included in the production of a single vehicle, provided by many different suppliers (tier 1, tier 2, etc.). Knowing what is included in their product enables auto makers to ensure that they comply with relevant legislation.
GADSL: In 2005, the IMDS published the Global Automotive Declarable Substance List (GADSL) for all chemical industry suppliers. This list details all the requirements regarding 3,126 reportable substances, including those which are prohibited and restricted. Each supplier downstream, from tier 1 until the final supplier, enters the compositional data into the IMDS based on GADSL. All non-listed substance formulations must be 90% disclosed.
- Impact: High. This commercial standard is used by the biggest OEMs. Today in the auto market, you cannot make sales if you haven’t submitted your product information to the IMDS.
RoHS: The Restriction of Hazardous Substances Directive 2002/95/EC (RoHS I) took effect in 2006, restricting the use of 6 hazardous materials (heavy metals and brominated components) in the production of electronic and electrical equipment. In 2011, RoHS II brought in the requirement of periodic re-evaluations that facilitate gradual broadening of its requirements to cover additional electronic and electrical equipment, cables and spare parts, and the chemicals involved. This means that new chemicals will be added in the future. PVC, DEHP, and antimony trioxide were almost incorporated in 2011 but were spared due to a strong chemical lobby.
- Impact: High. Producers are required to give compositional data of the products they supply. Safety Data Sheets (SDS) under REACH will also compel producers to divulge their formulations. For ‘article’ manufacturers such as those in the adhesive tape industry, everyone must be conscious of the added composition of their products.
REACH: The biggest change for tape businesses, according to Ms. Aerts, came in 2008 with the enforcement of the framework of Registration, Evaluation, Authorisation and restriction of CHemicals (REACH), an EU regulation which initiated a wave of global legislation which is still under formulation, evaluation, enforcement, and scrutiny.
- Impact: High. Many adhesive-tape-related businesses supply directly or indirectly to the electronic and electrical equipment markets. The end producer is required to put the “ϹЄ” label on the finished good to prove it is RoHS-compliant.
CLP: This EU regulation which aligns classification, labelling and packaging of chemicals and mixtures with the Globally Harmonised System (GHS) came into force in 2009. The US utilises different labelling, but the goal is to adopt the GHS of communicating about hazardous chemicals to make it easier to market products everywhere. The GHS comes from an international agreement to which many countries already adhere.
- Registration is one obligation under REACH which compels those who produce or import chemicals and mixtures (and perhaps polymers in the future) in quantities of 1 tonne or more per year to register these substances with the European Chemicals Agency (ECHA). Evaluation by ECHA of all registered chemicals started 2 years ago.
- Impact: Very high. This affects the entire adhesive-tape-manufacturing industry, because information on chemicals and formulations must be communicated up and down the entire supply chain. Companies who manufacture or import the chemicals which go into the production of adhesive tapes – thus in many cases both tape manufacturers and raw materials suppliers – either individually or in forums, must submit expensive dossiers to ECHA.
- The registration dossiers cover the use and assessment of the hazards and potential risks due to the substances themselves, sometimes including Chemical Safety Assessments (CSA) and Chemical Safety Reports (CSR). Depending on the chemical and the number of co-registrants for the same substance, dossier preparation expenses range from €1,000 to almost €1 million (if lead registrant).
- During evaluation, ECHA and the Member States will examine the quality of the registration dossiers and the testing proposals to clarify if given substances constitute a risk to human health or the environment. They may then decide to ban or restrict substances. Tape manufactures and raw materials suppliers must constantly check which chemicals are under evaluation and keep up with relevant EU discussions taking place on those chemicals.
- Under authorisation, Substances of Very High Concern (SVHC), those which cause cancer or mutations, for example, will be progressively banned. The goal is that SVHCs are properly controlled and replaced by suitable alternatives in phases. From past experience, tape manufacturers and raw materials suppliers have learned that it takes 6 to 8 years before a substance is banned, although this depends upon the chemical, as in some cases they have been banned very quickly. Currently 161 substances are candidates to be banned; 31 have already been banned. Authorisation to continue limited use of a banned chemical as it is being phased out requires an application costing between €200,000 and €500,000, with no guarantee of approval.
- Restrictions may limit or ban the manufacture, selling or use of substances. A restriction applies to any substance on its own, in a mixture or in an article, including those that do not require registration. It can also apply to imports. Today 60 restrictions are in force – many for use in consumer goods. Oftentimes a restriction is published with immediate effect, so there is little time for businesses to adapt.
Global regulation: Based on EU Chemicals Policy, an increasing number of countries, such as Korea, Malaysia, China, the US, and Japan, have adopted stricter legislation in this area than ever before. China in particular has adopted a similar but tougher regulation than REACH. Japan has also made its existing chemicals legislation more stringent and has adopted GHS. Other countries such as Canada, the US, and Brazil, are studying REACH while considering tightening their own legislation.
- Impact: High. All labels tape-related businesses put on their products classified as mixtures according to REACH must be based on CLP, along with SDS. This includes European hazard symbols and Risk and Safety Statements for labelling.
- Impact: High. Chemicals will not only be banned and restricted in Europe but in other parts of the world and eventually worldwide. At the moment, restriction of chemicals across regions is not uniform, so while some substances are prohibited or restricted in Europe, others are affected in China. This makes it very difficult for adhesive tape manufacturers and raw materials suppliers, and, in particular, for those within these businesses who are responsible for monitoring regulatory affairs. These professionals need to keep abreast of public affairs worldwide on a daily basis and to determine how it will affect their organisations.
What chemical legislation can we expect in the future?
In terms of the development of future chemicals regulation, Europe remains the frontrunner and model for the rest of the world. Canada, for example, is working with ECHA to share information and to ban or restrict many of the same chemicals.
REACH will become stricter, not more lenient
By 2020, as part of the SVHC Roadmap implementation plan, the EU has committed to include all relevant, currently known SVHCs in the Candidate List for authorisation as part of the REACH authorisation process to ban substances and to promote substitution. This means that the Candidate List will grow from 161 substances to over a thousand, a development which will greatly impact the business around substances and formulations used to manufacture tape. Ms. Aerts assures the audience that no amount of lobbying by the largest chemical companies has been able to affect the application of REACH in its initial implementation phase.
Scandinavia is driving chemicals policy in the EU
Methylene diphenyl diisocyanate (MDI), for example, is a known crosslinker and is currently restricted and listed on the Danish List of Undesirable Substances (LOUS). Europe looks to the Scandinavians, and specifically the LOUS published by the Danish Environmental Protection Agency, to drive the EU’s chemicals legislation. Canada, as part of its Chemicals Management Plan, also monitors the LOUS and is looking at banning MDI in co-operation with the EU.
In addition to substances in mixtures, the EC is evaluating whether to require the registration of polymers under REACH. This would especially affect manufacturers of hot melt tapes and films. If similar costs would apply to the registration process of polymers, this would have a huge impact on the tape business, especially in imports and exports.
EU regulation on ‘articles’
REACH covers substances and mixtures, but the tape industry is mainly concerned with the manufacture of ‘articles’. By 2018, the EC would like to enact legislation for a non-toxic environment, and part of this would cover articles, including most adhesive tapes and films. It is currently unclear what the scope of a future regulation would be, but this a developing issue which the adhesive tape industry should monitor.
How to deal with regulatory issues in your company
In order to succeed, adhesive-tape-related organisations will have to adapt efficiently to developing legal requirements by incorporating regulatory affairs into their business models. Ms. Aerts suggested the following:
- Manage regulatory affairs specifically as a separate department or integrated team: Larger companies have divisions dedicated to regulatory affairs, but within many SMEs, public policy is considered a newly necessary discipline. Should it be handled by R&D? Safety/environment? Product stewardship? Whatever the case, regulatory affairs must be monitored on a daily basis by specialised personnel.
- Create customer intimacy through utilising a system of compositional data: Communicate regulatory developments with your customers. Even after 6 years of REACH, Ms. Aerts explains, each time new chemicals are published on the Candidate List, Nitto sees many more customer requests. Utilise a database to monitor what products contain in order to ensure compliance and to provide your customers with peace of mind.
- Treat regulatory affairs management as part of development: If a new product is in the development stage, or if a customer has a question or wants something changed or modified, such as a type of adhesive, regulatory affairs managers must be part of the team in order to check the legal status of the substances and mixtures considered for use. You may think certain chemicals are ‘green’, but they may not be safe for both health and environment. Support both business development and sustainable development.
- Include regulatory affairs management in product procurement: If you import products from other regions, companies have to know what the product contains and to ensure compliance with registration obligations or written notification requirements.
- Make regulatory affairs management a part of the sales process: Salespeople deal with many questions regarding banned and restricted substances, and they need to have clear answers for their customers. Sales personnel need to possess basic knowledge of regulations so they are able to provide feedback and ultimately peace of mind to their customers. The importance of the relationship between regulatory affairs management and sales force will only increase in the future.
- Form regulatory support for each region if you are an international company: This applies to many adhesive-tape-related companies. Having support for your teams in each region of representation is important. This presentation mainly concerns European legislation, but Chinese legislation may be just as important to the success of your business.
- Let regulation be a driver for innovation: Europe as a region leads in regulatory affairs affecting the adhesive tape industry; it also leads in innovation. Incorporate regulatory affairs into your company’s strategy for solutions research and innovation.
About Amy Aerts
As Regulatory Affairs Manager at Nitto Europe NV, located in Belgium, Amy Aerts focuses on the EU regulation REACH and its implementation within the company. She manages a team which handles compliance, gathering data, and customer requirements. Ms. Aerts also advises Nitto sites in the UK, Hungary, Turkey, Norway, and the Czech Republic. Among others, Ms. Aerts holds master’s degrees in chemistry and REACH obtained from Ghent University.
Questions and Comments?
Regulatory Affairs Manager
Nitto Europe NV
T +32 89 360 585
M +32 475 78 81 20
3600 Genk, Belgium