Afera’s guide to regulatory affairs for tapes

For the tape industry, the regulatory landscape is continuously evolving, and active involvement is critical if European businesses want to succeed. Below you will find an overview of the most important regulatory developments for tape businesses and recommendations as to what the industry and individual companies can do to prepare for these.

Why learn the rules?

European regulatory affairs can be confusing, especially for the newcomer. The rules are different and don’t seem to make sense in everyday life. But if you gain a better understanding of what they are and how they come about, you can actually make them work for your business. The rules can also hurt you if not followed correctly. Learning how the legislative process works and how to bend and shape the developing regulations and directives according to your business’ advantage is key. And making sure those rules meet the requirements of the tape industry – and that they do not hurt us – is also Afera’s goal.

Understanding the 3 levels of E.U. legislation

• E.U. regulations: These are directly binding in all E.U. Member States (MSs).

o Framework regulations on very broad requirements for certain topics
o Specific regulations on individual aspects of the regulated subject
o Guidance documents, manuals of decision, FAQs, amendments, comments, corrigenda.

• E.U. directives: The E.U. defines what the MSs need to achieve, and the MSs are free to choose the instruments with which they achieve them. Thus the means may vary among countries.
• Local or national legislation: This may not be harmonised among the MSs. Some local or national legislation goes beyond what the E.U. requires.

What applies to tapes?

First understand the broad legislative requirements for the elements that make up tapes, independent of the final application of the tape. Then look at the application of the tape in the article or end product and the specific requirements attached to this. Then ensure that your tape or article meets those requirements.

• REACH: The European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals
• CLP Regulation/GHS: Classification, labelling and packaging of substances and mixtures
• Risks Related to Chemical Agents at Work: Directive 98/24/EC
• Carcinogens or Mutagens at Work: Directive 2004/37/EC
• The Industrial Emissions Directive: Directive 2010/75/EU
• Packaging and Packaging Waste: Directive 94/62/EC
• The Biocidal Products Regulation (E.U.): 528/2012
• Application-specific legislation, such as in the areas of food packaging, medical devices, toys, electrical equipment (e.g. The RoHS Directive restricting the use of hazardous substances in electrical and electronic equipment).

REACH

Together with CLP, REACH is the biggest piece of chemicals legislation in the world. REACH is a regulation which obligates any company that manufactures or imports a chemical in excess of 1 tonne per year and puts it on the European market to register that substance. In this manner, the European Commission obtains information from the chemicals industry, evaluates it, and decides how to manage its mechanism for keeping hazardous chemicals off the market.

Registration entails submitting a technical dossier containing information on the properties, uses and classification of a substance as well as guidance on safe use. Registration is limited to one dossier per substance put on the market, and the process is not known for being inexpensive.

Preparation of technical dossiers, depending upon the chemical and the available data, can run over a million euros. To reduce costs for industry and relevant agencies, registrants are required to submit jointly information on the hazardous properties of the substance and its classification, and can, if they agree, also jointly submit the chemical safety report (CSR). The intention is that registrants will save money by co-operating on the preparation of the dossier through consortia. This allows the tape industry to share the burden.

Evaluation includes both a dossier and substance check. The E.C. checks the quality of the registration dossiers and the testing proposals. Both the E.C. and MSs clarify whether a substance constitutes a risk to human health or the environment by requesting further information from industry.

Authorisation & SVHCs Based on this evaluation, the E.C., with the aid of the MSs, may develop guidance on the prioritisation of substances for further evaluation, i.e. decide that a substance is “of very high concern” (SVHC). This means that a chemical will be put on a list of substances which need to be authorised by the E.C. before it is used on the market. As of September 2017, there were 174 entries on the Candidate List of SVHC for Authorisation and 31 already banned.

The ultimate goal with SVHCs is that they are properly controlled and replaced by suitable alternatives. If you are desperate to use a substance, you can apply for temporary authorisation which may be granted for a unique application cost running between €200,000 and €500,000.

Restriction occurs when the E.C. limits or bans the manufacture, placing on the market or use of certain substances where there is an unacceptable risk to health or the environment. Any substance on its own, in a preparation or in an article, including those that do not require registration, may be subject to E.U.-wide restrictions. At present there are 65 substances restricted under REACH. One such restriction relevant to the tape industry is toluene, which is limited in use to 0.1% by weight.

Deadlines

Registration deadlines are 3-tiered according to volume of the substance used. If you were to put a chemical on the market in excess of 1,000 tonnes in volume per year, you would have needed to register it by 30 November 2010. If you put a chemical on the market between 100 and 1,000 tonnes by volume per year, the deadline would have been 31 May 2013.

For the lower tonnage chemicals (between 1 and 100 tonnes by volume per year), the deadline is 31 May 2018. For this volume level however, there may be challenges. If these are specialty chemicals that only a few companies use, the sharing of costs may be more difficult. Additionally, less data may be available for this tier of lower tonnage chemicals.

The deadline for late pre-registrations for substances that need to be registered by 31 May 2018, was 31 May 2017. For substances that have not been (late) pre-registered, potential registrants need to submit an inquiry to ECHA before registering. If a manufacturer or importer does not register by the appropriate deadline, the substance may not be manufactured in the E.U. or placed on the E.U. market until it has been registered. Registered substances can in principle circulate freely on the internal market.

For all substances that are manufactured or imported in volumes of 10 tonnes or more per year, a chemical safety assessment (CSA) has to be carried out and recorded in the registration dossier as a stand-alone document, which is called the CSR. Upon submission, all registration dossiers must pass a ‘completeness check’ by ECHA to ensure that all elements required by the legislation (including the required information and the registration fee) have been provided.

Late fines

Infringement of deadlines will be punished according to the location of activity of the perpetrator. In general, fines range from €50,000 and €1 million for the first offense. In Belgium however, fines can reach €55 million, and in the U.K. they are unlimited in amount. REACH infringements may have implications in criminal law as well.

Who exactly is responsible?

In terms of REACH, the main roles of industry with varying obligations:

• Manufacturer: Produces a substance.
• Importer: Imports the substance from outside the European Economic Area (EEA)
• Downstream user (DU): Uses chemicals or formulates mixtures to produce articles, e.g. makes adhesives or fabricates tapes, without putting them on the market themselves.

o Formulator: Produces mixtures which are usually supplied further downstream, e.g. adhesives, lubricants, cleaning agents and coatings.
o Producers of articles: Incorporate substances or mixtures into or onto materials to form articles (e.g. tapes), which include both components and finished goods.

• Distributors: Store and/or distribute chemicals to the European market.

A company may perform multiple roles under REACH and CLP.

Tapes are articles 

REACH defines an article as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition.” Tapes are technically considered articles, and as such, producers of tapes are considered DUs.

Where does REACH apply geographically?

REACH applies in the EEA, which is the E.U. plus Norway, Iceland and Liechtenstein. Importers from these countries are not considered imports for the purposes of REACH. An importer of a substance from Norway, Iceland and Liechtenstein is simply regarded as a distributor or DU.

What you need to do within supply chain

How do manufacturers, importers and DUs or customers interact under REACH? The stream of communication should look like:
• The registrant of a substance must prepare the registration dossier, and for substances that are manufactured or imported more than 10 tonnes per year, this also includes the CSR.
• Registrants are required to assess the use of the substance throughout its life cycle. Therefore, as a first step, they need to gather information on the use of their substance in the supply chain, i.e. through a direct line from their customers.
• The registration dossier and the CSR document the conditions of safe use. Exposure scenarios (ESs) were introduced with REACH, and they document conditions of safe use for specific uses or groups of uses. ESs submitted to the European Chemicals Agency (ECHA) are expected to contain thorough justifications for the information that is included.
• The CSR remains with ECHA, while the safety data sheet (SDS), which should contain information which is consistent with the CSR, is the vehicle to communicate information on safe use to customers.
• SDSs may include ESs. ESs for communication are expected to be simpler than ESs submitted to ECHA, and they should concentrate on outlining in a clear manner the operational conditions and risk management measures which result in safe use of that substance. The use of standard formats and phrases is recommended.
• ECHA has published templates for CSRs and ESs.

What DUs have to do

SDSs

• As a producer of tape, if you receive an SDS, implement the appropriate risk management measures. 
• Check the ESs to ensure that your use is covered. If your own use of a substance is not covered, as the DU you must take alternative action such as: 

o request your supplier to include your use
o change your supplier
o substitute the substance or process, or
o prepare a DU CSR.

• Make sure to inform your suppliers about new information on hazards and inappropriate risk management measures. 
• See How downstream users can handle exposure scenarios: Practical Guide 13 and Guide on safety data sheets and exposure scenarios.

Chemicals of concern

• DUs need to use harmonised classification if available. 
• You must investigate whether you can substitute this particular substance for something else. 
• You must also check if there are any restrictions or authorisations that may apply to that chemical in determining whether you can freely put it on the market.
• For tape manufacturers, it is important to note that if a SVHC is incorporated into an article at above 0.1% in weight, additional requirements apply. You may need to notify ECHA or inform customers regarding the presence and safe use of the SVHC.

CLP

Closely linked to REACH, classification and labelling identify hazardous chemicals and inform users about their hazards through standard symbols and phrases. They need to be harmonised to ensure good worldwide understanding and to facilitate the free flow of goods.

Focussing on effective sharing of information on chemicals, manufacturers, importers and DUs classify substances and mixtures based on the rules laid out in the CLP. Most substances and all mixtures are self-classified, but more hazardous substances have harmonised classification at the E.U. level. A classification inventory of over 120,000 substances has been built from over 6 million notifications.

Based on these classifications, suppliers label and package their substances in accordance with CLP. Manufacturers, importers and DUs must communicate the substances they are using to ECHA’s CLP inventory.

New European Court Ruling

The European Court of Justice (ECJ) ruled in September 2015 that the 0.1% threshold for notifying SVHCs in articles applies to “each of the articles incorporated as a component of a complex product,” i.e. the backing/adhesive and liner, rather than to the entire article. Previously, the 0.1% threshold could be calculated for the product as delivered, e.g. a car.

Afera immediately issued a position paper stating that the definition of a “component” article should remain independent from the manufacturing process. For tapes, our industry views the backing adhesive as one non-separable “composite article” rather than two separate ones. The tape and the liner may be two separate articles.

The E.C. started work on a draft guidance document, and Afera retains a seat in the respective partner expert group. Afera has provided critical input into the guidance document, the first draft of which was released in July 2016. Released in October 2017, the final version, entitled “Guidance on requirements for substances in articles”, can be viewed here. Industry feedback can be submitted through December 2017.

Afera, CheMI and supporting DU interests

Afera arranged its seat in the partner expert group above through its membership in CheMI, the European Platform for Chemicals Using Manufacturing Industries. Afera sees its role as a platform on which DU associations can work together, looking at such critical issues as the impact of REACH on DUs. Unfortunately the E.C. tends to focus on the impact of regulation on the companies with which it is directly working, such as chemical suppliers and importers, and less on downstream obligations.

CheMI has been an active participant in the REACH process, producing a roadmap and numerous positions on implementation. It retains seats in the Direct Contact Group (DCG), in the Sherpa Group and direct links with the E.C.

How you can take it from here – now!

If you are a chemical supplier, you probably don’t even have time to read this article, because you are neck-deep in registration activities. If you aren’t, don’t assume that for every substance there is a consortium and/or a complete infrastructure in place. You may have to start from scratch, and at this late date, doing so will be a challenge.

For the manufacturers of tapes and formulators of adhesives, you need to:

• Check the compliance of your suppliers: Have they registered their inventory of chemicals you are using? If not, urgently alert them to this or start finding new suppliers.
• Check for SVHCs: Are one or more present in your article or formulation? If so, specific risk management measures must be taken.

What Afera is doing

Meanwhile, through our Regulatory Affairs Working Group (WG), Afera is keeping track of the changes in REACH and how they might apply to you. We are keeping you informed and basically trying to keep the E.C. from making life “more interesting” for us.

BREF STS

Along with other associations, Afera has been working closely with the E.C. for the last two years on updating the Best Available Techniques (BAT) reference document (BREF) on Surface Treatment Using Organic Solvents (STS), which was adopted in 2007 under the E.U. Industrial Emissions Directive (IED) and covers 18 industries. Adhesive tapes are mentioned (“adhesive application in the manufacture of abrasives and adhesive tapes”) in the BREF, which contains the minimum standards for solvent-based coating of abrasives, films, etc. for Europe.

The BREF will most likely impact national laws affecting production plants with a VOC consumption capacity of more than 150 kg/hour or 200 tonnes/year. The BATs are seen as more than recommendations as many E.U. countries have integrated the techniques and emissions levels into national environmental legislation. The ultimate goal of the update process is to gain a better understanding of the BATs in existence in order to limit VOC emissions. The E.C. has looked at the possibility of merging adhesive tapes and labels.

Afera looks on its involvement in the BREF update process as critical to the tape industry. The Association is coordinating input for the installations that fall within the BREF STS’ scope. Crucial in the industry’s input is not only current emissions levels, techniques in use, and the latest BATs, but those “BATs” established in 2007 that were not used or proven irrelevant. The end result should contain emissions levels which reflect the industry’s best but reasonable capabilities.

As a member of the Surface Treatment using Organic Solvents Technical WG (BREF STS TWG), Afera attended an informational workshop with the E.C. and MSs in May 2017. During this event, we reviewed the data that the E.C. has extracted from our submissions to ensure that there weren’t any errors in interpretation. Until the final draft is issued in 2018, Afera will monitor the update process closely and supply any further relevant information.

How can we help you?

Afera has recognised the need to intensify its regulatory affairs work as the domain has increased in relevance to our industry. Now regulatory affairs policies determine whether you can be in business or not. As mentioned above, Afera’s Technical Committee has engaged my services as its public affairs manager and has also set up a Regulatory Affairs WG consisting of experts from tesa, IVK/FEICA, Nitto, Lohmann and 3M. The Association currently holds seats in CheMI, the European Paper Recycling Council (EPRC) and the BREF STS TWG, and enjoys close links with Cefic (The European Chemical Industry Council), FEICA (the European Adhesive and Sealant Association), IVK (the German Adhesives Association) and many other associations.

Afera’s goal is to monitor and act decisively on environmental issues on behalf of the tape industry, whether that means holding close discussions with institutions or participating in stakeholder meetings and working groups. And at the same time we want to make the issues and processes more understandable to you. If you have any ideas or suggestions about topics that we should be focussing on, please contact me.

About Mark Macaré

Mark Macaré holds a BSc in Chemical Engineering and an MSc in Innovation Sciences, specialising in renewable energy policy. After working for the Dutch Ministry for the Environment on the European Emissions Trading Scheme, and as a Science and Technology Officer for an office of the Ministry of Economic Affairs in California, he joined Lejeune Association Management in 2008.

Mr. Macaré has helped establish and currently manages one of the largest REACH consortia, EtOH-REACH and its subgroups. He is also Secretary General of RadTech Europe, the European Association for UV and EB Curing, and is involved in a number of other associations, including FINAT. Since the beginning of this year, Mr. Macaré has taken on the role of Public Affairs Manager for Afera.

Questions and comments?

Mark Macaré
Public Affairs Manager for Afera and FINAT
Lejeune Association Management
MMacare@lejeune.nl
www.afera.com
www.etoh-reach.com
www.radtech-europe.com
www.finat.com
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