Regulatory and Product Safety Updates

EU 2023/1115  
 
What is the EUDR?         
The European Union Deforestation Regulation is a mandatory law designed to ensure that specific products placed on, made available on, or exported from the EU market are not contributing to global deforestation or forest degradation.

(EU) 2019/1021
What are POPs?
POPs (Persistent organic pollutants), are substances that persist in the environment and accumulate in living organisms, posing a risk to our health.

How are they regulated?
POPs are regulated globally by the Stockholm Convention and the Aarhus Protocol. These treaties are implemented in the EU by the POPs Regulation.

What does the regulation do?
The Regulation prohibits or severely restricts the production, the placing on the market and use of POPs. The use of around 30 different substances and their derivatives or salts are prohibited.

Could there be POPs in my products?
This is a list of some of the most commonly found POPs and in what products they can often be found:

Polychlorinated Biphenyls (PCBs)
Older transformers, capacitors, industrial oils, hydraulic fluids, some paints, sealants, adhesives

Polybrominated Diphenyl Ethers (PBDEs) (DecaBDE, PentaBDE, OctaBDE)
Electronics (circuit boards, casings), upholstered furniture, mattresses, car seats, textiles, children’s toys

Hexabromocyclododecane (HBCDD)
Insulation foams, building materials, upholstered furniture, textiles, automotive parts

Short-Chain Chlorinated Paraffins (SCCPs)
PVC cables, wiring insulation, electronic casings, lubricants, adhesives, industrial metalworking fluids

Perfluorooctane Sulfonic Acid (PFOS) & Perfluorooctanoic Acid (PFOA)
Stain-resistant and waterproof textiles, non-stick cookware, food packaging (fast-food wrappers, popcorn bags), firefighting foams, coatings

Per- and polyfluoroalkyl substances (PFAS, broader group)
Cosmetics (waterproof mascaras, eyeliners), automotive coatings, food packaging, firefighting foams

Pentachlorophenol (PCP)
Wood preservatives, treated lumber, agricultural pesticides (historically used)

Lindane, Chlordane, DDT, Mirex (Legacy Pesticides)
Insecticides, termite treatments, soil and grain treatments (historical use, some legacy contamination)

How is this regulation being enforced?
In recent months there have been a spate of product recalls across Europe related to POPs. The most common of these has been from the use of SCCPs (short-chain chlorinated paraffins) in everything from electronic cables such as USB cables, toys and children’s products, stationery and sports equipment and games.

What other countries have regulations around POPs?
Most other countries have regulations that include bans or restrictions on POPs.

What should I be doing?
Make sure your supply chain is aware of these bans, and for any soft plastics you have on your products, ensure you or your supplier has tested them for SCCPs.

If you are yet to put together a robust strategy for managing materials compliance within your business, I can help.

2011/65/EU
What is RoHS?
RoHS stands for Restriction of Hazardous Substances. It is a European directive that restricts the use of certain hazardous materials in electrical and electronic equipment (EEE).

What is its objective?
The goal of RoHS is to reduce environmental and health risks associated with various substances, particularly during the production, recycling, and disposal processes of electronic devices.

What products need to comply with RoHS?
RoHS applies to almost all electronic and electrical equipment, including household appliances, IT equipment, lighting, toys and medical devices with some specific exclusions. The restrictions therefore also apply to all materials or components that will be used in EEE products.

What does RoHS restrict?
RoHS limits the use of the following hazardous materials in electronic products:

• Lead (Pb)
• Mercury (Hg)
• Cadmium (Cd)
• Hexavalent chromium (Cr⁶⁺)
• Polybrominated biphenyls (PBBs)
• Polybrominated diphenyl ethers (PBDEs)
• Four phthalates (DEHP, BBP, DBP, and DIBP)

What are the concentration limits?
The maximum allowable concentration of these substances in each material is:

• 0.1% (1,000 ppm) for all substances except cadmium.
• 0.01% (100 ppm) for cadmium.

Does it only apply to the EU?
The UK RoHS requirements mirror those of the EU. China and India have similar regulations.

How do I comply?
Key requirements include ensuring each of the materials in your EEE meet the requirements, create your technical documentation, create your EU declaration of conformity and affix a CE mark to your EEE product.

If I supply components or materials for EEE products, what are my obligations?
If your customers are selling their products into countries with RoHS regulations, they will need to ensure all of the materials they use comply. Therefore they will likely ask you for test certificates or declarations before they purchase from you. They could also choose to test your materials themselves. If you are placing your components directly onto the EU market or a market with RoHS requirements, and they are very obviously components for EEE (such as cables) then they need to comply with RoHS although they will not necessarily need a CE mark.

Need help with your RoHS compliance? Make contact and we will arrange a time to talk.

How do I pronounce Phthalate?
Phthalate is pronounced “Fell-late”

What is a phthalate?
Phthalates are a group of man-made chemicals that are structurally related to the organic acid, phthalic acid.

What are phthalates used for?
The most common use of phthalates is in plastics, especially PVC, where they act as plasticisers. A plasticiser is a chemical additive that makes materials softer and more flexible. As an additive they will generally not appear on product or material labels. Another common use is in products that contain fragrances. Phthalates are used as solvents and fixatives to help preserve fragrances and help them to linger.
As well as being found in plastics and vinyl products, and products containing fragrances, they are also found in safety glass, lubricating oils, food packaging, adhesives, paints, inks, medical tubing, blood bags, pharmaceuticals, footwear, electrical cables, stationery, nail polish. Here is a list of some common phthalates and their applications:

What are the risks associated with the use of phthalates?
Exposure to phthalates happens through food, skin, and air. Phthalates are not chemically bound in the materials they are added to, so they can easily leach out or evaporate.

Several phthalates, for example DEHP, DBP, DIBP and BBP may damage fertility or the unborn baby and interfere with our hormonal system (Endocrine Disrupting). In particular, they affect the sexual development of boys which can lead to infertility in adults. Pregnant women and young children have been found to be the most vulnerable groups to the effects of phthalates. DEHP, DBP and BBP, are also harmful to the environment, more specifically are very toxic to aquatic life, and often with long lasting effects.

What bans and restrictions exist around the use of phthalates? (non-exhaustive list of some key regulations):

How do I know if my products contain phthalates?
Talk to your material suppliers and ask for declarations or certification for the relevant regulations. You can also send samples of your products to a test laboratory for testing.

Need help getting your material compliance up to date? Talk to us about we can support you.

What is Proposition 65 (also known as Prop65) and how does it relate to products?
Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a proposition of the State of California enacted as a ballot initiative in November 1986. The proposition protects the state's drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals. These chemicals are found in many products.

What is the Proposition 65 List?
The Proposition 65 list is a list of a wide range of naturally occurring and synthetic chemicals that cause cancer or birth defects or other reproductive harm. These chemicals include additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust. They could also occur as contaminants in commonly used materials. In plastics and electronics, fire retardants, heavy metals and phthalates are commonly used.

What is included in the current list?
The current list includes over 1000 chemicals and is regularly updated. Many of these can be found in plastics, coatings, textiles and electronic components.

What do I have to do as a product developer, supplier or manufacturer?
If you supply products to the USA that may be sold in California, whether through a physical store or online, you need to ensure warnings are provided that relate to any of the chemicals in the list that may be found in your products. The warning must be present at the point of sale and must be in a particular format.

How do I know whether my products contain any of the listed chemicals?
There are a number of different ways you can determine this. The first step is to talk to your supply chain and request certifications or declarations as to the Proposition65 status of the materials or parts you purchase. If your product contains batteries, plastics, electronics, metal coatings, dyes or fire retardants, there is a higher chance that your product will contain some of the listed chemicals.  Contaminants, particularly in recycled plastics, may also be a source.

Are there any exemptions for the warning label requirements?
The OEHHA has developed safe harbor levels for many Proposition 65 chemicals under which a warning would not be required.  Where the OEHHA has not established a safe harbor level for a chemical, businesses that expose individuals to that chemical would be required to provide a Proposition 65 warning, unless the business can show that the anticipated exposure level will not pose a significant risk of cancer or reproductive harm.

How does the process of compliance benefit my product development business?
While the process of determining what chemicals are found in your products can seem like a lot of work, greater transparency into your supply chain and the composition of your products is part of the process of building greater knowledge within your business. Gaining this level of insight and detail can help you make better product decisions that benefit your customers and the environment, and can also protect the health of those throughout your supply chain. Additionally, you can better anticipate future scarcities around materials, further future restrictions in other markets and improve the properties of your products.

How do I get started?
We can help you to put together and implement a strategy around addressing the requirements of this and other similar chemical regulations for products.

www.rbdevelopment.co.nz/connect
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