Regulatory Ripples

Regulatory Ripples: 

Shaping the Future of Tube Manufacturing & Packaging

In this edition, we explore the latest regulatory obligations affecting tube manufacturers and the packaging industry in general. From stringent restrictions on coatings and printing inks to the impending ban on Bisphenol A in food contact materials, the articles present the most pressing challenges facing the industry. Additionally, we delve into the Corporate Sustainability Reporting Directive (CSRD), the directive that affects around 50,000 companies and poised to transform the sustainability reporting process in Europe. Join us as we navigate the complexities of regulatory compliance that will usher the packaging industry into the future.

Coatings and Printing Inks in the face of Regulatory Storms

Coatings and printing inks play a pivotal role in the packaging industry, serving as not just aesthetic enhancers but also as crucial elements for preserving product integrity and ensuring consumer safety. However, despite their indispensable role, coatings and printing inks are currently under regulatory scrutiny due to concerns over the potential health and environmental impacts of certain chemical components. This could pose a significant challenge to the industry, as it navigates the complexities of compliance while striving to maintain product efficacy and consumer confidence.

Per- and polyfluoroalkyl substances (PFAS): Biggest restriction proposal in European Chemicals Agency’s history

Despite having diverse applications in various industrial sectors, PFAS are currently coming under regulatory pressure. Recently, five EU chemical agencies proposed restrictions on PFAS-based materials under REACH, affecting approximately 10,000 substances. While aimed at mitigating environmental harm, a blanket ban could significantly disrupt industrial production in Europe and jeopardize essential applications. Tube manufacturers could be affected by such ban, as PFAS-based materials are common ingredients in various coatings and printing inks.

Proposed restrictions on polychlorinated biphenyls

The European packaging industry faces uncertainty with proposed restrictions on Polychlorinated Biphenyls (PCBs), which currently lack EU-wide limits. The Commission's proposal suggests a stringent 10 ppm threshold for PCBs as Unintentional Trace Contaminants (UTC) under the Persistent Organic Pollutants (POPs) regulation. This proposal has sparked concerns within the packaging industry, particularly regarding certain pigments commonly used in printing inks. Inks containing chlorinated organic pigments or requiring chlorinated solvents in their production, either struggle to meet a 10 ppm PCB limit consistently or contain PCB levels ranging from 1 to 10 ppm. The abrupt implementation of a 10 ppm threshold without a sufficient transitional period could lead to a disruption in the supply chain. Collaboration between regulatory bodies and industry stakeholders is crucial to navigate these complexities effectively, ensuring environmental sustainability and resilience in the packaging sector.

Five substances designated as substances of very high concern (SVHC)

On 23 January 2024, the European Chemicals Agency (ECHA) added five organic materials to annex 14 of the REACH regulation (list of substances of very high concern). These materials are commonly used in the production of coatings and printing inks, therefore potentially relevant for the packaging industry. Further use of SVHC above 0.1% in products triggers various legal requirements such as:

  • Obligation to notify ECHA within 6 months of the substance addition to the list
  • Obligation to register the product in the SCIP database under the Waste Framework Directive
  • Obligation to provide Safety Data Sheets to customers.

The continuous regulatory pressure on the coatings and printing inks industry reveals the ongoing tendency towards stricter regulations for the chemical industry, impacting the packaging industry that relies on the continuous supply of effective coatings and printing inks. The proposed restrictions on PFAS and PCBs, as well as the designation of new relevant substances as SVHC, underscore the need for industry adaptation. Proper communication between tube manufacturers and their coatings and printing inks suppliers is essential to accurately assess the possible impacts on the industry. Finally, navigating these regulatory requirements demands a concerted effort between regulatory bodies and industry stakeholders to ensure compliance without compromising innovation and functionality in packaging materials.

Corporate Sustainability Reporting Directive (CSRD):
New European Standards for Non-financial Reporting

In its ongoing efforts to re-orient investments towards sustainable technologies and businesses, the European Commission recently adopted the CSRD. The directive revises and strengthens the rules introduced by its predecessor, the Non- Financial Reporting Directive (NFRD). It aims to ensure that companies report reliable and comparable sustainability information that investors and other stakeholders need. It will also prevent the unnecessary costs incurred by the companies due to the uncertainty about the relevance and quality of the reported data.

The directive significantly widens the scope of its predecessor. The NFRD covered only 11,700 companies and groups having more than 500 employees designated by national authorities as public interest entities. On the other hand, the CSRD will apply to nearly 50,000 organizations including all large enterprises starting 2025 and stock market-oriented Small and Medium Enterprises (SMEs) from 2026.

New European standards for sustainability reporting

To ensure a level playing field throughout the EU market, the EU Commission published the first set of the European Sustainability Reporting Standards (ESRS). These standards are comprised of 2 Cross-cutting Standards, 10 Thematic Standards (1 for Governance, 4 for Social and 5 for Environmental aspects). Specialized standards tailored for Small and Medium-sized Enterprises (SMEs) are planned for release in 2024. Furthermore, the commission is planning to publish sector specific standards along with standards for large non-EU companies before July 2026. These standards are rigorous in concept and quality, with external audits being mandatory, which can pose a significant load for the affected companies.

What are the necessary steps to comply with the directive?

Companies should conduct a materiality assessment encompassing various steps. This involves a risk-based analysis of the value chain, followed by the identification and evaluation of impacts, opportunities, and risks, along with identifying relevant stakeholders. Subsequently, companies will be able to determine the necessary information to be reported. Additionally, a gap analysis and action plan should be established, aligning the CSRD requirements with the current sustainability status. This involves defining internal adjustments, such as processes, metrics, and controls. Furthermore, companies should solidify reporting processes, finalize controls, improve information reliability, prepare for third party-audits, and gear up for the implementation of the Electronic Single European Format (ESEF) for digital tagging of the reports.

In conclusion, the companies which fall under this new legislation are expected to publish a sustainability report that entails the various ESRS requirements like data collection, content drafting, third-party verification, and digital publication as part of the management report.

Navigating the Bisphenol A Ban in Food Contact Materials:
A Paradigm Shift in Packaging Sector

In the realm of packaging, Bisphenols have long been a staple for both interior and exterior coatings of containers. The usage of Bisphenol A (BPA)-containing coatings has been highly functional, boasting an extremely broad spectrum of applications. However, recent developments have brought to light significant health concerns associated with these compounds, which triggered the European Food Safety Authority (EFSA) to revise its opinion on usage of BPA in Food Contact Materials (FCMs).

On 19 April 2023, EFSA published its new opinion on the matter. The provisional tolerable daily intake (TDI) derived by EFSA in 2015 (4 micrograms per kilogram of body weight per day) was reduced by a factor of 20,000 to yield 0.2 nanograms per kilogram of body weight per day. Consequently, the European Commission (EC) made an announcement in May 2023 regarding the prohibition of BPA in FCMs.

The draft for this regulation was finally unveiled in February 2024, initiating a public consultation phase until 8 March 2024. According to the outlined plan, the intentional use of BPA in FCM will be banned 18 months after the regulation comes into force. Longer transitional periods are granted for certain applications, an opportunity that can be utilized by tube manufacturers to find suitable alternatives. For example, the use of BPA in the outer coatings of tubes (along other packaging formats) will be given a 36-month transition period, which is double the basic transition period of 18 months. The same elongated transitional period will apply to packaging of „high-acidity foods“. Another significant aspect of this regulation is the obligation to notify brand owners at least nine months prior to the end of the transition phase, signaling the cessation of BPA use in in food packaging. Compliance declarations, along with pertinent documentation, must accompany the product during all marketing stages.

Industry position

Industry stakeholders highlighted the challenges in finding alternatives for all applications, despite the industry’s best efforts to completely replace BPA in food packaging over the past decade. There is also criticism regarding the disregard for the opinions of organizations such as the German Federal Institute for Risk Assessment (BfR) and the European Medicines Agency (EMA), with both publishing a significantly less strict opinion on the matter. Moreover, counterparts like the Food and Drug Administration (FDA) in the United States continue to allow BPA usage under reasonable limits. As different regions continue to authorize the use of BPA, the implications of this ban will not be confined within the EU's borders. Export-oriented companies fear potential repercussions on their global competitiveness and many importers will not be able to import packaged foods into the EU, if they do not comply with the new regulation.

The current focus of the EU Commission involves revising the draft text to align it with the outcomes of ongoing discussions and to address relevant feedback received during the public consultation phase. Subsequently, the updated text will be circulated to Member States ahead of the Standing Committee on Plants, Animals, Food, and Feed (PAFF) meeting. Additionally, the World Trade Organization (WTO) will be notified under the Technical Barriers to Trade (TBT) Agreement. Upon approval by the PAFF standing committee, the measure will proceed to the European Parliament and the Council, initiating the subsequent phase of the regulatory process starting from July 10. As the packaging sector braces for this regulatory overhaul, it is evident that a fundamental shift is underway. The journey towards safer packaging practices is fraught with challenges, but the packaging industry is committed to consumer safety and sustainability.