Callaghan Innovation in New Zealand provides R&D funding for those wanting to commercialise a product for the first time. This includes Regulatory and Compliance support. What is the New to R&D Grant?
This grant supports those businesses or individuals getting started with R&D activities. You will have a concept and need support to commercialise your idea. What is the funding for? The R&D costs associated with your first project and Capability Building How much funding is given? 40% of your R&D costs to a maximum of $400,000. What criteria needs to be met?
Training, coaching and advisory to increase capability (ask about our capability building courses) What activities can Regenerative Business Development support?
More information can be found here. Are you applying for the New to R&D grant from Callaghan Innovation? Have you identified that you will need Regulatory and Compliance support? Contact me to make a time to talk. Developing products with batteries requires the addressing of risks related to the transportation of the product. In what products are Lithium-Ion batteries commonly used? Lithium-Ion batteries are rechargable batteries that are generally found in products such smart phones, laptops, scooters and E-bikes. In what products are Lithium metal batteries commonly used? Lithium metal batteries use lithium metal as an anode and are commonly used in items such as watches, car key fobs, remote controls and some toys. What is the risk? Lithium batteries present a safety risk to aviation because they use a positively charged electrode that contains oxygen and if the battery is exposed to excessive heat or pressure, it can catch fire. Currently there is more than one aviation incident a week related to lithium batteries in the USA alone. Additionally, the number of batteries in increasing rapidly across the globe as is the energy density in the batteries which is further increasing the risk. What requirements must my product fulfil for air freighting? It is important to talk to your shipping company or freight forwarder to make sure they are across the requirements for shipping of batteries in or with your products. They will need to be providing a shippers declaration in most instances. The key requirements you will need to be aware of are:
  The above table is based on the provisions set out in the 2023-2024 Edition of the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air (Technical Instructions) and the 65th Edition (2024) of the IATA Dangerous Goods Regulations (DGR): http://www.iata.org/dgr
The provisions of the DGR with respect to lithium batteries may also be found in the IATA lithium Battery Shipping Regulations (LBSR) 11th Edition: http://www.iata.org/lbsr Refer to our article on the new EU battery regulation for additional battery related requirements. European cybersecurity standards affect developers of connected products. When will these product standards become mandatory under the RED?
It is expected that this will be 1 August 2025 meaning you have one year to prepare. The standards still need to be added to the harmonised standards journal by the EU. What are the EN18031 series of standards? EN 18031-1:2024 Common security requirements for radio equipment - Part 1: Internet connected radio equipment EN 18031-2: 2024 Common security requirements for radio equipment - Part 2: radio equipment processing data, namely Internet connected radio equipment, childcare radio equipment, toys radio equipment and wearable radio equipment EN 18031-3:2024 Common security requirements for radio equipment - Part 3: Internet connected radio equipment processing virtual money or monetary value What are the objectives of compliance with these product standards? From Article 3.3 of the RED, these standards seek to:
What products are covered by these standards? Connected products. Any devices capable of communicating over the internet, either directly or through other equipment. This includes devices that may handle sensitive data, including personal data, traffic data and location data. Examples include: mobile phones, tablets, laptops, wireless toys, children’s safety equipment (such as baby monitors) and wearable devices, such as smartwatches and fitness trackers. What are the product testing requirements? Product Developers or manufacturers must conduct tests focusing on network security, data protection, and the integrity of communication protocols. Devices should be evaluated for their resilience against unauthorized access and potential fraud scenarios. Why should I as a product developer, become familiar with these product standards and start planning for compliance now? The forthcoming Cyber Resilience Act is aiming to strengthen cybersecurity across the EU for digital products, meaning that these standards are only the start. It is important to get on top of these now so that you are better prepared for what else is coming. https://www.rbdevelopment.co.nz/connect _____ Chemical compliance is part of product compliance and affects your product development decisions. 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 _____ The EU has strict requirements (GDPR) related to collecting customers data via your products or website. EU 2016/679
What is the GDPR? The GDPR defines precise rules on the management of security incidents such as data breaches, the use and erasing of collected personal data, and the keeping of records relating to data processing activities. When did the GDPR take effect? The General Data Protection Regulation (GDPR), took effect on the 25th of May 2018, and last year (2023) there were over a billion euros in fines for breaches, demonstrating there is still some work to do to ensure that everyone is in compliance. What are the rules around the reporting of data breaches? The regulation requires that personal data breaches (this includes all personal data such as contact details) must be reported to the competent supervisory authority within 72 hours. Data subjects must also be notified. Violation of the duty to report data breaches, can be punished by fines of up to EUR 1 million or, in case of companies, of up to 2 % of the total global annual turnover of the preceding financial year, whichever is the higher. What information am I obliged to provide when collecting personal data from subjects via my product or other means? The identity of the controller and deputy controller of the data and their contact details, the purpose and categories of recipient, contact details of the data protection officer, the controller’s legitimate interests, any intention to transfer data to a third country or to an international organisation (and the Commission’s associated adequacy decision), how long the data will be stored, the data subjects’ rights to information, erasure, correction, restriction the right to revoke consent, the right to appeal to a supervisory authority and so forth. Additionally, the reasoning behind, and consequences of, any profiling activities that may be performed. How long can personal data be held for? Personal data must be held only for as long as it is necessary to carry out the purpose for which the data is processed. Once the data is no longer needed for the purpose for which it was collected, personal data must be deleted. If data subjects withdraw their consent to the use or processing of their personal data, organizations are obliged to delete the relevant information. Under this regulation, when is it lawful to process personal data? This is only lawful when at least one of the following criteria has been fulfilled:
The data subject is entitled to revoke their consent at any time. This process must be as simple as granting consent. The awarding of a contract, or provision of a service, may not be made dependent on the data subject’s consent, unless the data processing to which the data subject is to give his consent is required in order to fulfill the contract. The processing of sensitive data is forbidden as a matter of principle unless the data subject’s consent has been obtained. What are my requirements as a product development business in terms of protecting personal data? The controller responsible for processing is required to take appropriate technical and organisational measures in order to ensure that personal data is processed in conformity with this regulation and must provide evidence that this is the case. A (documented) risk assessment is required. Need some help to get started or to review your existing activities for compliance? Get in touch. www.rbdevelopment.co.nz/connect __________ Europes ecodesign regulation provides helpful guidence for developing more sustainable products.
What products are covered by this regulation?
This Regulation applies to any physical goods that are placed on the market or put into service, including components and intermediate products. What products are excluded? Food; feed; medicinal products; living plants, animals and micro-organisms; products of human origin; products of plants and animals relating directly to their future reproduction; vehicles (but not including scooters and bicycles – these are included); items for defense. From when does it apply? This regulation entered into force on the 18th of July 2024 and enforcement will begin in 2 years from that date. However, if you are developing new product, now is the time to ensure you are aware of the requirements. What are some of the requirements? Product durability, reusability, upgradability and repairability, as well as the use of substances that inhibit circularity are mentioned. Additionally, it covers energy and resource efficiency, recycled content, remanufacturing and recycling, and the carbon and environmental footprints of products. This Regulation also establishes a ‘digital product passport’, provides for the setting of mandatory green public procurement requirements and creates a framework to prevent unsold consumer products from being destroyed. An EU declaration of conformity will also be needed for your product, along with CE marking. There are also a number of information requirements that must accompany a product. What is a Digital Product Passport? A 'Digital Product Passport' requires a QR code on a product that takes a consumer to information that enables them to make informed purchasing decisions by offering details about a product's environmental sustainability. It thereby allows consumers to access and compare information contained within these product passports. What ‘unsold products’ can no longer be destroyed under this regulation? The regulation imposes a direct ban on the destruction of unsold textiles and footwear, which will take effect two years after enactment. Small and micro companies are exempt, while medium-sized companies have a six-year exemption. It also authorizes the Commission to introduce similar bans for other products in the future. From 19 July 2030, medium sized enterprizes that discard unsold consumer products directly or have unsold consumer products discarded on their behalf must disclose the amount, the reason and any recovery actions taken annually on their websites. What is ‘ecodesign’? The regulation defines ecodesign as “the integration of environmental sustainability considerations into the characteristics of a product and the processes taking place throughout the product’s value chain” What ecodesign requirements will be implemented? Further detailed requirements will be adopted going forward to improve the following product aspects: (a) durability; (b) reliability; (c) reusability; (d) upgradability; (e) repairability; (f) the possibility of maintenance and refurbishment; (g) the presence of substances of concern; (h) energy use and energy efficiency; (i) water use and water efficiency; (j) resource use and resource efficiency; (k) recycled content; (l) the possibility of remanufacturing; (m) recyclability; (n) the possibility of the recovery of materials; (o) environmental impacts, including carbon footprint and environmental footprint; (p) expected generation of waste. What products are the priorities for what is yet to come? (a) iron and steel; (b) aluminium; (c) textiles, in particular garments and footwear; (d) furniture, including mattresses; (e) tyres; (f) detergents; (g) paints; (h) lubricants; (i) chemicals; (j) energy related products; (k) information and communication technology products and other electronics. Want to understand how to prepare your product development business and products for this regulation? Contact us for a free no- obligation 30 minute online consultation to discuss what assistance may be of most relevance to you. www.rbdevelopment.co.nz/connect __________ Becoming an industry leader involves understanding product risks, and employing a range of tools to help you do that.What is Safety Gate? Safety Gate is the rapid alert system for dangerous non-food products in the EU. It is the system through which all non-food product Recalls are processed through. How does it work? National market surveillance authorities (the relevant authority in each EU market + Iceland, Norway and Liechtenstein) monitor products to check they meet EU requirements. If a national authority detects a dangerous product on the market, it may ban or restrict its sale, stop it at the border or order for it to be recalled. When one national authority takes such a measure, it has to inform all the other countries in the EU, which happens through Safety Gate. The Safety Gate rapid alert enables swift and effective action to be taken across the EU when a dangerous product is found. What products are covered? Safety Gate alerts cover consumer products and products for professional use but excludes pharmaceuticals, medical devices, food or animal feed (which have their own alert systems). What types of safety risks are commonly covered? Threats to human health and safety, such as choking, strangulation and damage to hearing or sight, or various hazards caused by chemicals. Products that pose a security risk or risks to the environment. How are dangerous products found? National authorities carry out inspections and test products on the market under their national market surveillance programmes. They also act on any complaints or information they receive about the possible presence of dangerous products on the market. Additionally, where manufacturers, retailers, importers or other businesses become aware they have inadvertently placed dangerous products on the market, they must report this to the authorities. How are incidents reported? A web portal called Safety Business Gateway is available for this purpose. As from 13 December 2024, its use will be compulsory. Who uses the Safety Gate system? National authorities from 30 countries (EU Member States, plus Iceland, Liechtenstein and Norway) enter information on Safety Gate in the form of alerts on a daily basis. What information is recorded? The alerts contain information about the product, the risks it poses, and the measures taken to stop it or restrict its sale. The measures can be imposed by the authorities (compulsory measures) or taken directly by the economic operators (voluntary measures). How is each country notified? National authorities are responsible for monitoring the alerts in the system and checking whether the product identified as dangerous is also for sale in their own country. They are required to report on the results of their checks with a follow-up notification on the Safety Gate. The notifications report any additional measures taken and any additional information available e.g. on distribution channels and affected batches. The public website is updated to show in which countries the product has been found and additional measures taken. What about online market places? Online marketplaces that have signed the Product Safety Pledge also check the Safety Gate to make sure they are not selling dangerous products online. The Pledge also commits them to remove such products from their listings within 2 days when requested by a national authority. In those cases, that measure is also inputted on Safety Gate in the form of a follow-up notification What did the 2023 Safety Gate report show? In 2023, there was a very high number of alerts due to increased market surveillance activity of national authorities. In particular market surveillance enforcement authorities increased their monitoring of cosmetics to check for the presence of banned dangerous chemical ingredients due to the enforcement of impactful restrictions of chemicals under REACH. As a result, ‘Cosmetics’ was the product category with most alerts rather than ‘Toys’ and ‘Motor vehicles’ which were top previously.  Source: Safety Gate 2023 Results What were the most prevalent product risks identified in 2023? The increase in the monitoring of cosmetic products has also caused an increase in alerts signalling chemical risks. Most of the cosmetics notified were reported to contain 2-(4-tert-butylbenzyl) propionaldehyde (BMHCA), a synthetic fragrance ingredient widely used in different types of cosmetics that has been banned from the EU market as of 1 March 2022. Dangerous chemicals were also detected in electronic devices. Examples include lead in solders and the presence of short chain chlorinated paraffins (SCCPs) in cables. There were also still many alerts reporting e-cigarettes with an excessive concentration of nicotine, and plastic dolls and other toys and accessories containing plastic softening phthalates, even though these substances in this type of product have been fully banned since 2019.  Source: Safety Gate 2023 Results Why should I monitor Safety Gate as a product developer or supplier in or to the EU or elsewhere?
Reviewing product recalls of products similar to yours or of risks that have the potential to be found in your products under certain situations, can be helpful input to your product risk assessments and continuous improvement programs. Market expectations can change overtime and what might be considered acceptable at one point in time can change as new information comes to light. Reviewing product recall information will help you to spot trends and pre-empt potential legislation or standards changes that are likely to occur overtime as they are updated to address newly identified risks. Don’t have time to monitor Safety Gate or similar databases used in other markets? Talk to us about receiving a customised monthly report summarising key information pertinent to your product development business and product range. www.rbdevelopment.co.nz/connect __________ There are a number of different documents that contain requirements for developing safe products.
What is an Act? Acts are laws that have been passed by a Parliament, Congress or State/Provincial Legislatures. For example, the Consumer Guarantees Act. These can also be called Statutes and are sometimes referred to as Primary Legislation. Acts protect everyone. For the EU, Treaties are the fundamental laws. All treaties must be ratified (passed and agreed) by member states. An Act will be people focused so will not usually refer directly to a product. What is a Regulation or Directive? Regulations are made under the delegated authority of an Act (or Treaty for the EU), such as an administrative agency. They can be considered to be supplementary to the Act or Treaty. They are designed to aid in the application of the principles of the primary Act. Regulations provide protection in specific areas. For example, the Electrical (Safety) Regulations. Regulations are sometimes referred to as Secondary legislation, Subordinate Legislation or Delegated Legislation. In the UK the term Statutory Instrument is used. In the EU Regulations are legal acts that apply automatically and uniformly to all EU countries as soon as they enter into force, without needing to be transposed into national law. They are binding in their entirety across all EU countries. The EU also generate Directives which differ from regulations in that they are a legislative act that sets out a goal that EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. Regulations can include some requirements that relate directly to specific or general categories of products. As a product development business you should understand the relevant regulations. How do Acts and Regulations Differ? An Act is generally a broader piece of legislation that outlines the general principles and rules of law, while a regulation is a more specific set of rules and requirements to enforce the provisions of the Act. Regulations are usually more specific and prescriptive, often providing detailed guidance on how the provisions of the Act should be implemented in practice. However, it is possible for an Act to be prescriptive also and in some instances to refer directly to a product safety standard. This means there may not always be a relevant Regulation. What is a Product Safety Standard? A Product Safety Standard is not, of itself, mandatory or legally required. A standard has to be incorporated by reference in an Act or delegated legislation in order to be mandatory. Once referenced, it becomes part of the technical regulation framework. In the EU, this is done through publication in the Official Journal of the European Union (OJEU) with respect to a particular Directive or Regulation. The product standard can then be used to derive a presumption of conformity with the essential requirements of that Directive or Regulation. This is what is referred to as a harmonised standard. In the UK these are called designated standards and their reference is published on GOV.UK in a formal notice of publication. In other countries standards are usually referenced from within an Act or Regulation. In Australia the ACCC (Australian Competition and Consumer Commission) release what they refer to as Mandatory Safety Standards (formally Consumer Protection Notices) directly under the Competition and Consumer Act 2010. These standards could be considered to be a cross between a Regulation and a Standard as they usually reference or duplicate sections of existing safety standards while also adding additional requirements. Product safety standards may prescribe a products form, construction, finish or packaging; tests the products must go through; and the form and content of any markings, warnings or instructions that must accompany the product. Do I need to be aware of the Acts and Regulations that apply to my products or can I just apply the relevant Standards? Acts often contain definitions which are important for the interpretation of Regulations and in some instances can refer directly to product safety standards, mandating them. Therefore, having a quick scan over the Act(s) that are relevant to your products is useful. Regulations can directly reference Standards and Regulations or Directives can often contain general requirements relating to your product or your responsibilities as a product developer/manufacturer, importer, distributor or retailer. It is also important to understand how your product standard(s) relate to the regulation. Are they referenced or harmonised? Which version is mandated or which clauses? Note that in different countries, slightly different versions of product standards may be referenced and it is important to ensure you cover the correct version of standard for each market you are selling in, in reference to that countries Regulation or similar. Have further questions or need some help in working out what is relevant to your product? Get in contact with us. www.rbdevelopment.co.nz/connect __________ The general product safety regulation (GPSR) applies to all products not covered by other legislation and sold in the EU.
What products are excluded?
When does it come into effect? On 13 December 2024 it will replace the current General Product Safety Directive and the Food Imitating Product Directive What are its objectives?
What is new? Being a regulation rather than a directive means that this imposes clear and detailed rules without risks of divergent transposition by Member States. Some specific new requirements include (this is not an exhaustive list, refer to the regulation for further detail):
How should you prepare as a product development business?
4. Have a plan in place for reporting to the EU Safety Business Gateway and carrying out a product recall Get it touch if you need any support with implementing the above, of if you have further questions. www.rbdevelopment.co.nz/connect __________
What are the regulations key objectives?
  Need help understanding how this regulation applies to you as a product development business? Get in touch.
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Global Product Compliance UpdatesProduct regulatory requirements are changing frequently. Check in there to read about some that might affect your products.Categories
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