Regulatory compliance takes a great network and the right company setup—which could give you a competitive advantage

Afera’s latest Webinar in its pre-Conference autumn biweekly series covered “Current and future challenges in regulatory affairs for the adhesive tape industry.” After an update on E.U. regulatory affairs, a panel of experts including Ingrid Wasbauer, regulatory affairs manager for Nitto Belgium, Miriam Verbruggen, product safety manager at Lohmann GmbH & Co. KG, Dirk Lamm, head of corporate product stewardship at tesa SE, and Pablo Englebienne, regulatory affairs manager for Afera, commented on the definition and scope of regulatory affairs, challenges in the job, essential systems and technology, and priority topic areas such as ‘polymer REACH’, endocrine disruptors, downstream user requirements and BREXIT.

E.U. regulatory developments

Sustainable products initiative inception roadmap consultation until 2 November
The European Commission has announced a new inception roadmap consultation for the development of a Sustainable Products Initiative. The goal is to revise and expand the Ecodesign Directive, which currently only covers energy-related products, to include other key areas of the Circular Economy Action Plan, such as electronics, furniture and textiles. The consultation is open through 2 November. This topic is being monitored by Afera’s Sustainability Working Group (Sus-WG).

Updated Food Contact Materials Consultation (11/2011)
The Food Contact Materials Regulation has been updated for the 15th time. This includes the introduction of approved use of new substances, the definition of new migration limits and the measurement of migration in complete devices. The latter could be relevant if tape is included.

SCIP database 5 January 2021 deadline delay proposal
The SCIP database was developed by ECHA, the European Chemicals Agency, to collect information on substances of Very High Concern (SVHCs) included in articles, such as tapes, and complex products, such as cars and mobile phones, in order to provide them to waste handlers and recyclers under the requirements of the Waste Framework Directive (WFD). A legal deadline of 5 January 2021 has been established for the submitting of all information by producers, but this has generated conflict because of delays in the setting up of requirements and the implementation of the database by ECHA.

Afera is an active member of the Chemical Articles Waste Cross Industry Platform (CAWCIP), a loose group of E.U. associations consisting of the chemical industry, article manufacturers and importers, as well as the waste sector, that aim to discuss openly all issues related to the Circular Economy and, in particular, the SCIP database.

On 21 September 2020, a CAWCIP coalition of 40 industry organisations including Afera wrote a letter to E.C. President Ursula von der Leyen calling for action to solve implementation issues within the WFD, specifically the SCIP database. The signatories asked the E.C. to take immediate action to postpone the SCIP notification deadline by at least 12 months after the finalisation of the database, to conduct a feasibility study on the database and to adapt the database according to the outcome of the study.

In parallel to this initiative, some MEPs are also asking the same questions to the European Commission.

Panellists define ‘regulatory affairs’

There are many definitions of “regulatory affairs” held by companies in the adhesive tape industry. Mrs. Wasbauer, who works at Nitto Belgium, a tape manufacturer located in Genk, focuses on compliance and chemicals regulation in general and specifically REACH, the European Regulation on Registration, Evaluation, Authorisation and Restriction of CHemicals that entered into force in 2007. Fellow panellist Miriam Verbruggen, working at Lohmann GmbH & Co. KG which is situated in Neuwied, Germany, does the same. Lohmann is also located in China and the U.S., and regulatory affairs can be very application specific, relating to RoHS, Food Contact Materials or medical legislation, for example. Just as at Nitto, Ms. Verbruggen’s department also handles customer compliance requests. Dirk Lamm, located at tesa SE in Hamburg, Germany, handles sustainability issues in addition to the above.

Pablo Englebienne, Afera regulatory affairs manager and the session’s 4th panellist, sees his job through Afera as enabling our Members to keep producing—to stay in the market. But the same regulatory issues are just as important to downstream users, who also need to stay in the market through reliance on receiving products which are geared to their expectations and legal needs. “From my position, it is also very important to watch the development of regulations now in progress, such as the legislation extending from the Green Deal,” explained Mr. Englebienne. “By actively getting involved in the regulatory process, we have an effect on how regulatory work for our Members has to be carried out a few years from now.”

Organising and adopting regulatory affairs at the company level: collecting, filtering, translating and applying at speed

“Organising regulatory affairs for a company takes a big network, consultants, subscriptions to newsletters such as ECHA’s, and information from associations like Afera and IVK,” said Mr. Lamm, with which the other panellists readily agreed. Input from these sources has to be collated and monitored. Mr. Lamm noted that he was glad about Afera’s creation of a Regulatory Affairs Manager, who can advise and provide Member companies with the correct legislative parameters according to their businesses and those of their affiliates. “And then we have made created Elan training for our employees worldwide, including in the U.S. and Asia, so I can ensure that the information reaches those who need to know it,” he added.

“The great challenge is filtering through the enormous amount of information to determine what is applicable to our business,” Ms. Verbruggen commented. “For this, we have created a database approach, connecting regulations to products and impacts. We then try to distribute information in an automated way, and we have also developed regular trainings for employees.” She explained that the sheer amount of regulations emerging everywhere—not just in Europe—complicates the job, as does the language in which they are written. “Sometimes you need a consultant or somebody who has experience with a certain topic to translate it into your business focus.”

The others also use technology to support the process. “I know that most IT tools are expensive, as we also use software systems which help us comply with regulations,” Mr. Lamm shared. “We have a database which lists each raw material and the corresponding regulations worldwide—this is very helpful. Ms. Wasbauer agreed: "From an IT perspective, indeed I think it is important to have a software setup like we do, that incorporates a lot of regulations. This already helps us.” She added that integrating regulatory affairs should be a lean and transparent companywide process from the point of procurement of raw materials up to sales and even the end-of-life of the materials. And as Ms. Verbruggen suggested, repeated training over all departments is required.

“Proactively collecting as much regulatory information as possible and then translating this as swiftly as possible into an organisation can give you a competitive advantage,” revealed Ms. Verbruggen. “Earlier than everyone else—that is correct,” Mr. Lamm continued. “I also have to translate or break down the information for our employees, because the original material is only for specialists, and we do not understand it.”

Priority regulatory topics for panellists: Scale and diversity are most important

Substances
“I think Industry should think seriously about the substances it is utilising, especially our suppliers,” offered Ms. Verbruggen. “An increasing number of substances are under scrutiny now, and in the future they may be restricted or authorised, but to replace them, you need a lot of time, and it is best not to wait until they are regulated to start work working on them.” In this case, it is especially good to follow ECHA’s activity closely.

Ms. Wasbauer added that in addition to the almost impossible number of new European requirements coming at Afera Member Companies, many REACH-like regulations are popping up in countries like the U.K., Turkey and Korea. In order to deal with this, “we have to realise that we cannot do this by ourselves,” she emphasised. “You need a network in order to tackle the scale and diversity of regulatory affairs in a tape-related company.”

Is it possible to look at the cost (of compliance) to market of a company’s product, imbed this into your process and delist it if the cost of compliance is too high? “To a certain degree, it can be calculated,” answered Ms. Wasbauer. “For example, you can calculate the expense of registration but not all the hours you put into it.”

Polymer REACH
For Mr. Lamm, most important on the horizon is the upcoming registering of polymers: so-called ‘REACH for polymers’. In the original REACH Regulation, he explained, polymers were not included in registration—only the monomers that went into them. “This will be new to us, because polymers are not hazardous like other substances that have to be registered,” Mr. Lamm argued. “And so, we do not see as an industry the reason we have to register polymers. Some of my colleagues are involved in discussion around this on the VCI panel and in FEICA.”

“As it is something that is still being actively discussed, I think this was my first choice for a key topic for the tape industry: the requirements of polymer registration and REACH,” said Mr. Englebienne. “Last summer, a report issued by the Wood Consultancy proposed which polymers should be registered. This is still in discussion but is likely to have a significant impact and to require a significant amount of work from our Industry in order to comply with the thousands of substances which must be registered (but likely with reduced information requirements).”

Endocrine disruptors, downstream user requirements and the Green Deal
Beyond polymer REACH, Mr. Englebienne mentioned the designation of certain substances as endocrine disruptors and how this process is designed and carried out in Europe as a future issue which will impact the Industry. He will also monitor developments in the evolving requirements of downstream users of tapes, i.e. those producing the products such as medical devices, toys and cars which incorporate tapes, and how the Green Deal will affect tape production and use.

Moderator Bert van Loon remarked that in identifying their regulatory priority areas for their company focus, the panellists together defined a very heavy agenda for everyone working in regulatory affairs—“how complex and diverse and dynamic and impactful the work is!”

About BREXIT?

“I think if you have many raw materials suppliers in the U.K., you might have some problems,” commented Mr. Lamm. “In our case, most of tesa’s suppliers are located in Europe and Asia.”

Axel Hessland, managing director of technical affairs at IVK, the German Adhesives Manufacturer Association, added that BREXIT might become tricky if, as a downstream user, you export formulations (e.g. primer) to the U.K., and you are unaware of whether your substances or formulations have been registered with the U.K. authorities. “It could become quite time-consuming to figure this out,” he said. “If you export—or your customer imports—he or she has to ensure that all substances have been previously registered in the U.K., the same as in the E.U.”

Furthermore, the fixed BREXIT deadline of 1 January 2021 might present a problem to those registering similar raw materials from different suppliers. The current strict terms require registration of all of them with new numbers, although in 2 or 3 months’ time, revised legislation will probably streamline regulatory requirements. Unfortunately, registrants will find compliance difficult but mandatory in the meantime. More information can be found in the link below.

Priority topics according to Webinar participants

Webinar participants offered their input as to issues that they find important in today and tomorrow’s regulatory climate:

• Polymer REACH
• Ms. Wasbauer said that like tesa, Nitto is watching this, but it is not actively involved in it yet.
• Chinese restrictions on solvent use
• Will this impact the European industry as Chinese suppliers struggle to deliver?
• Registration with poison centres
• Microplastics, regulation and possible (organic) substitution
• You are considered a seller of microplastics if you sell tapes already converted for your customers to parts of less than 5 mm each.
• Xampla, a research company in Cambridge, is pioneering a new 'pea' protein to replace conventional materials. How far could the potential for this new material/technique extend?
• BREXIT and U.K. REACH
• Information on the grandfathering of registrations, pre-registrations and downstream users can be found here.

Afera’s Regulatory Affairs Working Group (Reg-WG)

Afera’s Reg-WG is expanding, becoming more active and currently building up its agenda. All of today’s panellists are also members of the group, which is seeking out more participation from Afera Members who are interested in keeping up-to-date and contributing to the Industry’s collective effort to participate in the regulatory process and to comply with all legislation. If you have ideas and would like to join the WG, drop Mr. Englebienne a line via regulatoryaffairs@afera.com.

Recording

The recording of the Webinar is available here using password yq*4S#*8. The Webinar slide deck including active links is also available upon request to the Secretariat.

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