Here's the next edition of our monthly bite-sized digest, Productwise 3-2-1 where each month, we'll be bringing to the top of your inbox (and your agenda):
- 3 key takeaways from the past month
- 2 hotbed issues you should keep your eye on
- 1 practice tip to keep you at the top of your game
This month it's all about the FDA's Artificial Intelligence and Machine Leaning Action Plan, the EU's sweep of websites for "greenwashing claims", the Green Consumption Pledge for products sold in the EU, plans to de-couple chargers from the sale of devices in the EU, federal upholstered furniture flammability requirements passed in the US and resources on recall insurance.
3 top things from the month just gone
- US FDA issues Artificial Intelligence / Machine Learning Action Plan. The U.S. Food and Drug Administration (FDA) published its Artificial Intelligence / Machine Learning (AI/ML) – Based Software as a Medical Device Action Plan on 12 January 2021. The Action Plan sets out five actions that the FDA intends to take to advance its oversight of AI/ML-based medical software following feedback from stakeholders. The five areas are: 1) update the proposed regulatory framework – this will include issuing draft guidance for public comment in 2021 on a predetermined change control plan (for software's learning over time); 2) encourage harmonisation of Good Machine Learning Practice Development to evaluate and improve machine learning algorithms through participation in collaborative communities and consensus standard development efforts; 3) Support a patient-centred approach incorporating transparency to users – this will include holding a public workshop on medical device labelling to support transparency and enhance trust in AI/ML-based medical devices; 4) support regulatory science efforts to develop methods to evaluate and improve machine learning algorithms; and 5) advance real-world performance monitoring pilots in coordination with stakeholders and other FDA programs. For further information see here.
- Results of EU sweep of websites for "greenwashing" claims published. The European Commission published the results of its yearly sweep of websites carried out with national consumer protection authorities to identify possible breaches of EU consumer laws. The focus of this sweep was on "greenwashing" (where businesses present a false impression of a product's environmental impact or benefits) and looked at online claims from a number of sectors including clothing, cosmetics and household equipment. After a broader sweep, 344 "seemingly dubious claims" were examined in more detail. The Commission and national authorities found that: 1) the trader did not provide sufficient information for consumers to judge the accuracy of the claim in more than 50% of cases; 2) the claim included vague and general statements such as "conscious", "eco-friendly", "sustainable" aimed at conveying an unsubstantiated impression to consumers that a product had no negative impact on the environment in 37% of cases; 3) and the trader did not provide easily accessible evidence to support the claim in 59% of cases; and 4) overall, national consumer protection authorities had reason to believe claims were exaggerated, false or deceptive and could potentially qualify as unfair commercial practices under EU rules in 42% of cases. The results of the sweep will feed into the impact assessment for the draft legislative proposal on empowering consumers in the green transition expected to contain measures on providing consumers with information about the sustainability of products (e.g. lifespan and repairability), target "greenwashing" and early obsolescence – expected in Q2 this year. There is also a complementary legislative proposal on substantiating green claims that aims to require companies to use harmonised methods – also expected in Q2 this year. For more information about the EU sweep see here.
- Green Consumption Pledge for products sold in the EU. The European Commission launched the Green Consumption Pledge on 26 January 2021 for non-food products. This is the first initiative being delivered under the New Consumer Agenda and aims to "ensure that sustainable products are available to consumers on the EU market and that consumers have better information to be able to make informed choices". It is a voluntary initiative that sits alongside other upcoming regulatory initiatives, such as a legislative proposal on substantiating green claims (discussed above). The initiative is similar to the Product Safety Pledge (but dealing with sustainability issues) and is asking companies that have signed-up to do more than is required under the current law by committing to take concrete measures in at least three of the five pledge areas (such as calculating the carbon footprint of flagship products and increasing the sale of sustainable products, among others). So far, five companies have signed-up to take part in the pilot phrase that will run for one year. We will post more about the pledge and what it could mean for all manufacturers of products sold in the EU in an upcoming blog. In the meantime, you can read more about the Green Consumption Pledge here.
2 to look out for
- EU "Common Charger" initiative, Commission considering whether to include measures to decouple the sale of chargers from mobile phones and other consumer devices. The European Commission has been continuing work on the Common Charger initiative, which aims to reduce e-waste by requiring harmonised chargers for mobile phones and other consumer devices sold in the EU. A survey closed on 22 January 2021 seeking views from stakeholders on whether to include measures in the initiative that would require the sale of chargers to be decoupled from the sale of mobile phones and /or other consumer electronic devices. The survey will form part of an impact assessment study on unbundling of chargers, feeding into proposals to be presented as part of the Common Chargers initiative. See our blogs here and here to find out more.
- SOFFA – US federal upholstered furniture flammability requirements passed. The Safer Occupancy Furniture Flammability Act (SOFFA), renamed as the COVID-19 Regulatory Relief and Work from Home Safety Act, was passed by Congress on 21 December 2020 (as part of the Omnibus Appropriations Act) and signed into law by outgoing President Trump on 27 December 2020. This Act ends decades of uncertainty regarding upholstered furniture flammability rules by mandating California Technical Bulletin 117-2013 (TB 117) as a federal flammability standard enforced by the CPSC. It also introduces a requirement for on-product labels certifying compliance with the new federal standard. Furniture manufactured domestically or imported on or after 25 June 2021 will need to comply unless the CPSC states it views the implementation dates differently. While this isn't a long timeframe most companies manufacturing upholstered furniture are already complying with TB 117 and will only need to implement the new certification label requirement. There is a pre-emption provision in the Act that prohibits state and local governments from establishing conflicting upholstered furniture flammability laws. However, this doesn't stop state and local governments from passing other health risk related legislation for upholstered furniture that is unrelated to flammability (e.g. chemicals).
1 top practice tip
- Product recall insurance – some helpful resources. A number of factors over the last few years, including the introduction of a new UK regulator (the Office for Product Safety and Standards) and an increased international focus on enforcing product safety regulatory regimes, have led to an increase in the frequency of product recalls. This, and the fact that recalls are becoming more complex and expensive, has strengthened demand for product recall insurance. Two of Cooley's insurance experts Richard Hopley and Sam Tacey have posted links to some useful resources on product recall insurance on our blog here.
Any comments or feedback, then please feel free to contact the authors, or any of your usual contacts within the team, who would love to hear from you.
The Cooley Products Team
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.