Tackling Regulatory Challenges

Interview with Bettina Jackwerth, Director Quality and Product Stewardship Personal Care Europe and Engin Temeltaş, Head of Product Stewardship & EHS Master Data Personal Care Europe at
BASF

Dear Bettina, dear Engin, you have been part of BASF's Personal Care team for a long time and have already seen a lot. What do you remember most from your journey so far?

Bettina: Compared to any past, the current times are the most challenging ones I have experienced in my almost 35 years in the industry. We never had such a dynamic regulatory situation and such a push towards increasing sustainability in many different areas, while also experiencing the need for our approach to match the cycles of the market. 

My career started at Henkel in the research area, and my next post was in global marketing in Personal Care with the longest time for Cognis. Just before the acquisition of Cognis by BASF, I took over a new assignment in the European marketing and had the great chance to shape together with others the integration of Cognis into BASF. About five years ago, I started in my current position, heading the European Product Stewardship and Quality group for Personal Care. 

Engin: Already in university, I observed that chemicals legislation would become an integral part of our “life in chemistry”. This was again confirmed when I started my career in the coatings industry at a different company. After the introduction of the European REACh (Registration, Evaluation and Authorization of Chemicals) regulation, I joined that company’s REACh implementation team, followed by taking over the responsibility for the European regulatory affairs team. In 2020, I arrived at BASF, where I took over responsibility for the Product Stewardship Europe team within the Personal Care business. Here, REACh is still a core item which keeps us busy, while at the same time, new regulations for protection of the environment, workers, and consumers are appearing all over the world. Sometimes it seems that this increase in regulatory action over recent years is growing exponentially.

And there is a lot to do for the next months or even years. How will legislation develop at European level? What will be on the list for the personal care world?

Engin: Over the last 15 years, REACh & CLP (Classification, Labelling and Packaging of Chemicals – the European version of the UN global classification rules) were regarded as “big” milestones in the European regulatory landscape that are a challenge for companies to comply with. After the last REACh registration deadline in May 2018, many industrial actors had the impression that REACh would be “over”. But industry has learned that the transition times for registration have only been the beginning of a changing regulatory world. An example is one part of REACh, the ECHA (European Chemicals Agency), which keeps regulatory experts busy while running dossier evaluation and requesting many additional toxicity data on registered substances. 

In parallel, more quietly the previous EU Cosmetics Directive has been replaced in 2013 by the CPR (EU Cosmetic Products Regulation), where one mandatory element is the ban of animal tests for cosmetic ingredients and products. This animal testing ban conflicts with elements in the REACh regulation, as REACh requires certain toxicity tests for workers’ protection – depending on production volume. There are still many important toxicological endpoints which can only be evaluated by animal-based test results. Although many companies – among those, BASF is one big player – and research organizations are active in developing alternative methods, it still will take decades until test data from those tests are commonly validated and accepted. In the meantime, the dilemma remains: while our customers formulate cosmetic products, consumers increasingly desire products, especially in the personal care segment, that provide claims such as “free from animal tests”. To protect workers who produce the chemical (cosmetic) ingredients, animal-based toxicity data is mandatory and required for hazard evaluation – so we are all in the same game of “the chicken and the egg”.

Meanwhile, non-government organizations (NGOs) are broadening the focus of discussion to areas that include human health and environmental protection. Environmental pollution based on plastics in oceans and other impact areas are part of these. The tonality used in this process fuels consumers’ uncertainty. The chemistry that surrounds us all then becomes something threatening and therefore voices for protection through regulation and policy are getting louder.

The European Commission expressed its target for protection of the population and the environment against harmful substances by means of the Chemical Strategy for Sustainability (CSS). CSS can be somehow regarded as a “summary” of all regulatory initiatives discussed over recent decades. Certain discussions on microplastic, “unintended” mixture effects and group approaches are now bound together.

The Chemicals Strategy for Sustainability gave the European Commission the opportunity to put the discussion on sustainability on everyone's desk. How can sustainability and regulation currently be reconciled?

Bettina: We at BASF – please remember our purpose, “we create Chemistry for sustainable future” – have had sustainability long on our agenda. It is implemented in all business processes and relevant company decisions. I am very proud that we in Personal Care – and here I can say globally – have been pursuing the sustainability journey together with our customers for decades. Nevertheless, the Green Deal gave another push to industrial sustainability and here specifically with the CSS to a toxic-free Europe. It is important now that the transfer into regulations is done with a good balance of all relevant aspects, e.g., protection of the environment on one side up to human health on the other. Scientific knowledge and well-acknowledged experiences need to be considered. 

Cosmetic Product Regulation (CPR) is under revision. The public consultation ended in July; a new EU Commission proposal is to be expected. What has been discussed in the last few months? 

Bettina: The CPR revision focuses on different topics for human health in relation to the CSS. The EU Commission proposal expected for the end of 2022 is now delayed to either Q1 2023 or even later, as the REACh revision is also delayed to potentially Q4 2023. Many of the topics to be addressed in this revision such as the consideration of new endpoints are strongly connected to REACh and the Classification, Labeling and Packaging (CLP) regulations. Thus, all regulatory initiatives should be established with scientific knowledge and a good balance of perspectives, which requires targeted advocacy by the chemical industry.

One center of competence on risk and safety evaluation of cosmetics is the Scientific Committee on Consumer Safety (SCCS). One current proposal of the intended revision of the CPR is around a closer connection of the SCCS to the EChA or even the Risk Assessment Committee (RAC). The chemical industry fears that the scientific knowledge and independence of the SCCS might be lost. If this organizational connection happens, it will become increasingly difficult for the industry to place new cosmetic ingredients into the market, as RAC’s decisions may sometimes be seen as hazard-driven instead of science/fact-based driven, and a well-working risk assessment related to the application might be abandoned. Additionally, a grouping approach for hazards, the evaluation of (undesired) mixture effects and new hazard classes are being discussed. In case of any new hazard class, our concern is that validated methods are partly not available, thus a product hazard evaluation cannot be based on proper proof. A product ban for ingredients must not be based on suspicion only. We do see it as a company’s responsibility to thoroughly know their ingredients and refrain from marketing those with a known and proven risk to the consumer, anyway. 

There is also a lot going on in the field of microplastics. What can we expect here?

Engin: “Microplastic pollution” is currently seen as one of the most important challenges as polymers (“plastic”) – due to their properties of degradation stability – accumulate in the environment and appear finally via maritime organisms in the food chain. Additionally, several starting (and degradation) materials like the chemical Bisphenol A have been identified as toxic to reproduction and showing endocrine disrupting effects. Although the cosmetic industry has always been a very minor contributor to microplastics, certain polymers have been used as “exfoliating” material. In fact, the use of “micro beads” is already banned in several regions in the world while some industry players have voluntarily committed to refrain from using such particles. The EU Commission, with the current proposal on the ban of “synthetic polymer microparticles”, i.e., “microplastics”, follows a strong approach to ban the use of “microplastic” for several industries using a rather broad definition for “synthetic polymer microparticles”; and, where the use is accepted for certain transition periods, an additional burden is created in extended labeling and reporting obligations throughout the supply chain. 

To overcome the “microplastic discussion”, the industry speeded up to develop more sustainable polymers – i.e., polymers which are biodegradable under potentially adapted and suitable methods, or which have improved water solubility. Up to now, replacing “microplastic” relevant polymers is quite a challenge for the whole industry.

The current draft release of the intended regulation at least gives some room for this change, as it foresees transition times of four years for rinse-off and six years for leave-on cosmetic products, and another twelve years for lip products. Nevertheless, also for those products under transition times, reporting and labeling obligations on safe disposal remain. Based on current planning of the EU Commission, we can now expect that the regulation will be entered into force earliest end of second quarter 2023.

How relevant do you consider the possible impact a company or the entire industry can have on regulation changes?

Bettina: The intended changes can and will transform the chemical industry and thus downstream industries as well. Therefore, we believe advocating in the process of regulatory revisions is a key responsibility of the industry to support the implementation of the right measures. Although BASF supports many of the intended regulations, it is important to find the right balance between protecting the environment and society and securing the competitiveness and innovation power of the European chemical industry. There is a great deal of scientific background that goes back decades on how even hazardous chemicals can be utilized under well-known application conditions or in industrial or professional use. Depending on the specific topic, education is important for informed decisions. We see the industry as a reliable partner for politicians in this process and trust in the mutual dialog for the best result. 

Looking beyond the EU’s borders, it is above all the Chinese regulations that have their challenges. What has changed here and how is this being countered in Europe?

Engin: China has released a new cosmetics regulation (CSAR – Cosmetics Supervision and Administration Regulation), which entered into force in 2021. After some delay in publication of subsidiary legislation, most of the relevant detailed regulations are now in place. The first hurdle in this new regulation is the notification of existing raw materials into a special raw material database. For “high-risk” ingredients like UV filters, the deadline was in December 2021, while the database system did not work properly. Currently, submission for “low-risk” ingredients is ongoing. While the database is still being modified, submitting companies must run certain updates on their current submissions, which results in a new submission code. Cosmetic product manufacturers must then use it to update their own product submissions. Even non-safety relevant updates result in new submission codes, which leads to an additional administrative burden for cosmetic companies.

For new cosmetic ingredients, there is a notification/registration requirement, depending on the ingredient group (high-risk/low risk). Although this difference exists, the amount of data to be provided is almost the same, supported by many administrative tasks like translation and, official “notarization” (i.e., official proof of the translation of the original study report). A big hurdle is the current acceptance of non-animal derived test data, which must be proven extensively. In many cases, where existing data from other studies is not accepted, new animal-based toxicity data must be created. This need for additional data creation again interferes with the animal testing ban and marketing-related discussions in Europe. 

Currently, there are many discussions with Chinese authorities and local cosmetic manufacturers and associations, but also with EFfCI (European Federation for Cosmetic Ingredients), to pragmatically navigate these obstacles.