Brussels 17 03 2022: Ansell, a global leader in personal protection solutions, has sent an ‘open letter’ to the European Union (EU) Commission and Industry Regulators, calling on them to urgently revoke requirements for Instructions for Use (IFUs) to be supplied in paper format with industrial products and allowing digital IFUs instead.

Rikard Froberg, President Industrial Global Business Unit, signed the letter, drawing upon Ansell’s acknowledged reputation in the global industry to urge amendment of the guideline requirements, and to request active encouragement for EU Member States to comply.

No Time to Waste

In emphasizing there’s - No Time to Waste – Ansell presents a powerful case for sustainability, describing benefits for manufacturers moving to digital IFUs in B2B environments, a practice already common for medical devices.

Highlighting technological developments and end-user behaviour, Ansell identifies a real opportunity to avoid further waste of natural resources; estimating that for its protective products sold in the EU alone IFUs currently require 45000 tons of paper annually.

Encouraging Digital IFUs to Significantly Reduce Paper Waste

IFUs ensure employers select the right equipment for employees and train them to use it safely. The governing EU Personal Protective Equipment (PPE) Regulation 2016/425 doesn’t expressly stipulate IFUs in paper format, however, the requirement for a paper IFU to accompany PPE products when sold is in the EU PPE Regulation guidelines.

Ansell’s position is guided by its responsible and responsive business strategy, based on clearly defined sustainability values and ambitions. Identifying three key areas – better society, better environment, and better business – Ansell is also appealing for support from regulators and authorities in recognizing future opportunities that contribute to these ambitions.

Toward Building a Better Environment

Ansell has voiced its agreement with recent initiatives taken by several EU Member States, related to Directive 94/62/EC, in establishing an identification system for packaging materials and packaging waste. In particular, the help in raising awareness among end-users about recycling.

Complexity and Confusion Rules

However, Ansell warns against the additional complexity and confusion created recently by the emergence of new rules and regulations in Italy and France. These refer in part to the recycling of PPE and the marking of packaging and packaging waste, potentially hindering free circulation of protection products within the EU.

Recognizing a Unique Moment to Build a Better Business

Ansell contends this piecemeal individual local labelling could be confusing, with a negative impact on EU-wide awareness and end-user action. Ansell’s aim is to create one single, harmonized recycling label for packaging materials and packaging waste.

Rikard Froberg stresses: “There is a unique opportunity for EU Regulators to take the lead and facilitate a harmonized approach that will bring more clarity for PPE users regarding packaging, sustainable disposal and recycling of the PPE packaging in the EU. We’re convinced this will ultimately lead to a more significant and positive environmental impact.”

Designed to Stem the Flow of Fake and Dangerous PPE

The unprecedented demand for PPE in the COVID-19 pandemic has also seen a concerning influx of new - and even existing PPE brands – selling products in the EU non-compliant with applicable regulations. These often don’t meet minimum protection levels or claim higher protection properties than they can provide. Despite this, their prices make them attractive to buyers.

Such practices are growing exponentially due to poor market surveillance and the absence of severe penalties to combat fraud. This increasing non-compliant PPE also creates an unfair competitive environment and could mislead customers, creating unsafe work environments and potential accidents.

Building a Better Society Needs Increased Market Surveillance

Ansell is taking a number of initiatives to ensure its products meet and exceed regulatory standards, and to educate the market on the regulation. These include strict release control criteria and continuous product assessment - ensuring processes and products match any claims made and can therefore be trusted by customers and end-users alike. The company also trains distributors in specific vigilance, while reporting to the European Safety Federation products non-compliant with the regulation.

Rikard Froberg concludes: “Ansell is committed to improving the environment, society, and our industry. With all the issues we identify in mind, we urge EU regulators and authorities for more market control and strict penalties when fraudulent protective equipment is brought into the European market. There really is no time to waste.”

ENDS