At Compliance & Risks we track global regulations, Standards and other documents across key policy areas all over the world. All topics are updated on a daily basis providing compliance news and alerts, requirement types, topics covered, materials and substances, products covered as well as key dates, deadlines, exceptions and exemptions, along with commentary from regional experts in the Americas, Europe, the Middle East, Africa and Asia.
Battery regulations are issued to prevent the release of hazardous substances into the environment, reduce waste and ensure the recycling of valuable raw materials.
We track regulations concerning manufacturers, importers and sellers of batteries, as well as products that contain batteries.
Regulations in this area may restrict the use of hazardous materials in batteries, require producers to take back and recycle waste batteries, establish marking and labeling requirements, and require that batteries in products be easily removable for disposal.
Related regulations may cover energy efficiency for battery chargers.
June 23, 2016 was a historic day which saw the UK vote by referendum to leave the EU. Since this seminal decision there has been more uncertainty than clarity on the path that lies ahead. Our Brexit News topic provides a high level overview, charting the progress of Brexit and what arrangements will be put in place once the UK leaves, focusing, particularly, on the impact of Brexit on your regulatory landscape.
California Proposition 65
California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) was enacted to protect California citizens and the State’s drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to inform citizens about exposures to such chemicals.
Proposition 65 is a “right-to-know law” that informs consumers if certain hazardous chemicals are present in products, or their packaging.
Proposition 65 requires the Governor of California to publish a list of chemicals known to the state to cause cancer, birth defects or other reproductive harm. The list contains a wide range of chemicals, including drugs, dyes, food additives, solvents, pesticides and by-products of certain processes. Some are ingredients of common household products, others are specialty chemicals used in very specific industrial applications.
Proposition 65 imposes controls on the chemicals on this list which are intended to protect California’s drinking water sources from contamination by these chemicals, to allow California consumers to make informed choices about the products they purchase, and to enable residents or workers to take whatever action they deem appropriate to protect themselves from exposures to these harmful chemicals.
Per Proposition 65, businesses are:
· Prohibited from knowingly discharging listed chemicals into sources of drinking water, and
· Required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to a listed chemical; this warning can be given by a variety of means, such as by labeling a consumer product, by posting signs at the workplace, or by publishing notices in a newspaper.
Under Proposition 65, a warning must be given unless a business demonstrates that the exposure it causes poses no significant risk.
Compliance & Risks’ coverage of Proposition 65 addresses the latest proposals, enactments and amendments to the Regulation.
A Carbon Footprint is defined as the potential impact of Carbon Dioxide (CO2) and other greenhouse gases (GHGs) emitted directly and indirectly by an individual, company, event or product.
Carbon footprints take two forms:
- Corporate Carbon Footprint (CCF) evaluates the entire product process of a company, together with upstream and downstream processes
- Product Carbon Footprint (PCF) covers the entire lifecycle of a specific product or service, including supply chain, use and disposal
Carbon footprint sources typically require manufacturers to:
- Affix a carbon footprint label on their products to denote the CO2 emissions created as a by-product of manufacturing, transposing or disposing of their products
- Certify that materials incorporated into a product or specific products are low carbon
- Report on the amount of greenhouse gases produced in the manufacturing of specific products
- Provide information on the carbon footprint of a specific product
- Offset the amount of carbon used which involves reducing carbon or GHG emissions in order to compensate for or offset emissions made elsewhere
- Pay a carbon tax
Compliance & Risks’ coverage of carbon footprint covers both mandatory and voluntary legislation.
Chemicals in Products
Compliance & Risks’ coverage of this topic focuses on proposed, new and enacted regulations and supporting documents on chemical substances in finished products, such as electrical and electronic equipment, batteries, packaging and toys, in addition to articles treated with biocides. It pays particular attention to regulatory measures on prohibited or restricted chemicals substances in finished products, and on biocidal substances in treated articles that protect articles from harmful organisms like pests, mold and bacteria.
The spectrum of global legislation addressed in this topic is wide, encompassing international instruments such as the Stockholm Convention on POPs (persistent organic pollutants), the Minamata Convention on Mercury, the Montreal Protocol on ODS (ozone-depleting substances). It also includes regional regulations such as EU REACH (Annex XIV on authorisation and Annex XVII on restrictions), EU RoHS, EAEU Packaging and RoHS Technical Regulations; China RoHS, California RoHS and Prop 65, and many more.
Beyond restricted and prohibited substances the topic also covers regulations requiring:
- Communication of information on the safe use of the products containing restricted substances to users
- Warnings to inform users about their exposure to such substances when using products containing them
- Reporting and notification to competent authorities (i.e REACH SVHC; SCIP under the Waste Framework Directive)
- Authorization for the manufacture and use during a certain period of a restricted substance in a specific product (REACH Annex XIV)
- Rules applicable to biocidal treated articles (i.e. registration, authorization/approval, labeling), etc.
Compliance & Risks’ coverage of this topic focuses on international and national measures concerned with the sound management of chemicals. It focuses on chemicals in their pure form or in mixtures and covers aspects such as classification, registration, harmonized labeling and more.
Whilst chemicals bring significant advantages, the drawback in their use is that they have the potential to impact both people and the environment negatively because they may be carcinogenic, endocrine disruptive, toxic to reproduction or persistent to environment.
In order to mitigate these effects and better protect human health and the environment, regulators across the world, through Multilateral Environmental Agreements (MEAs) and national policies, have developed regulatory measures and are continuously putting in place common principles and good practices for safe and ecologically sustainable chemicals management.
The following areas are covered under this topic of Chemicals Management:
- Notification, risk assessment and registration of chemicals in order to increase the information on toxicological and ecotoxicological properties of existing and new chemicals
- Control of industrial chemicals or hazardous substances
- Classification (as carcinogenic, mutagenic or toxic for reproduction, etc.), and labeling of chemicals in order to inform the user about the properties of the chemicals and to give advice for their safe use and disposal (UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS))
- Shared responsibilities in relation to the import of hazardous chemicals and an open exchange of information (Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade)
- Phasing out of the production and use as well as the waste management of Persistent Organic Pollutants (POPs) (Stockholm Convention on POPs);
- Observation, research and information exchange on the effects of human activities on the ozone layer and the adoption of measures against activities that are likely to have adverse effects on the ozone layer (Vienna Convention for the Protection of the Ozone Layer)
- Specific actions to control ozone-depleting substances (Montreal Protocol on Substances that Deplete the Ozone Layer)
Chemicals and EH&S: Environment
Environmental legislation is a collection of many laws and regulations which seek to protect the environment from harmful actions. Many of these measures are aimed at facilities with the objective of reducing the impact of such facilities on the physical environment.
Compliance & Risks’ focus for this topic is on environmental chemical legislation related to facilities (e.g. factories, offices) which imposes obligations with regard to:
- Reduction of the use of chemicals
- Reporting of storage and handling of chemicals
- Prevention of and response to accidental release of chemicals and major industrial accidents
Chemicals and EH&S: Occupational Health and Safety
Chemicals pose a wide range of health hazards such as irritation, sensitization, and carcinogenicity and physical hazards such as flammability, corrosion, and explosibility. Occupational Health & Safety (OHS), also commonly referred to as Occupational Safety and Health (OSH) or Workplace Health and Safety (WHS), is a multidisciplinary field concerned with protecting the safety, health, and welfare of people in the workplace from exposure to hazards resulting from work activities.
Worker exposure to chemicals is regulated via:
1) Education and Training (Hazard Communication)
- Information about identities and hazards of chemicals must be available and understandable to workers
- Employers with hazardous chemicals in their workplaces must have labels and safety data sheets available for their exposed workers, and train them to handle the chemicals appropriately. The training for employees must also include information on the hazards of the chemicals in their work area and the measures to be used to protect themselves
2) Occupational Exposure Limits
Employers are required to identify and evaluate the hazards of exposure to chemicals in their workplaces. Various types of Occupational Exposure Limits (OELs) have been established, like Permissible Exposure Limits (PELs) and Recommended Exposure Limits (RELs).
Compliance & Risks’ coverage of the Circular Economy allows you to track developments at a high level, focusing on global developments surrounding the transition from linear to circular economies. This Topic captures strategies, briefings, consultations, reports, as well as, proposed and enacted legislation concerning movement in the direction of the circular economy.
The concept of “Circular Economy” aims to keep resources in use for as long as possible and has a broad remit, touching on many diverse areas of regulation. It is gaining traction globally and represents a shift from traditional linear economies, where take-make-discard is the norm. It is a recognition of the un-sustainability of such an approach based on continual consumption of finite natural resources and has the worthwhile objective of keeping resources in use for as long as possible, encapsulating the thinking of reduce, reuse and recycle.
Our Circular Economy coverage compliments many of our core topics already covered in C2P including: Chemical Substances and Materials, Ecodesign, Energy Efficiency, Packaging, and WEEE. More in-depth information on the individual topics with which Circular Economy overlaps can be found by subscribing to those topics directly.
Climate Change regulations can typically be divided into two broad categories:
- “Industry” specific regulations, i.e., those that apply to industrial facilities by, for example, requiring companies to reduce their carbon/greenhouse gas (GHG) emissions by imposing GHG emissions targets and, in some cases, mandatory GHG reporting obligations; and
- “Product” specific regulations, i.e., those that impose restrictions/prohibitions on the sale of products manufactured using ozone depleting substances (ODS)/F gases.
Industry specific regulations
The manufacturing industry includes the highest carbon-emitting sectors in the global economy with one third of total greenhouse gas (GHG) emissions and the world’s energy consumption attributable to manufacturing.
This has resulted in an increased trend towards climate-friendly operations and energy efficient manufacturing practices and products, some of which are voluntary, whilst others are mandatory.
This increased regulatory framework is being driven by international organizations, such as the United Nations (under the auspices of the UN Framework Convention on Climate Change) and the European Union (EU).
The entry into force of the UN Paris Climate Change Agreement on 4 November 2016 was a pivotal milestone in this regard. The Agreement, which requires signatory governments to maintain global warming to no more than 2C above pre-industrial levels, provides that each State must submit a Nationally Determined Contribution (NDC) to reduce GHG emissions to achieve the temperature target.
The impact of the Agreement on businesses will therefore largely depend on whether those Member States will implement the measures outlined in their NDCs to meet their volunteered targets. These measures may include the introduction of carbon taxes and subsidies for green infrastructure.
Product specific regulations
Product-specific regulations, largely based on the United Nations’ (UN) Montreal and Vienna Protocols, cover products including refrigerators, air conditioners, fire extinguishers and electronic equipment, which are manufactured using ozone-depleting substances (ODS) such as CFCs, HCFCs, HFCs, PFCs and SF6. Other examples of “product specific” regulations include carbon footprint labeling/low carbon product certification (in Taiwan, South Korea, Japan and China).
Conflict minerals regulations require companies that use conflict minerals – tin, tungsten, tantalum, gold and their ores and alloys – to report on the source of those minerals and the due diligence conducted to verify the source.
Conflict minerals regulations come in response to ongoing armed conflicts in regions that produce minerals used in the production of consumer products. The purpose of the regulations is to prevent armed groups from funding their operations through the sale of minerals.
Under these regulations, importers of conflict minerals must carry out due diligence on their supply chain, checking where the minerals and metals they import have been mined and processed responsibly.
Consumer protection legislation covers the protection and enforcement of the rights of the consumer, focusing on legislation concerned with safeguarding consumers from trade practices which are unconscionable, unfair, unreasonable, unjust or otherwise improper, and from conduct deemed deceptive, misleading, unfair or fraudulent.
Compliance & Risks’ coverage of consumer protection not only tracks global key consumer protection laws and regulations, but extends to capturing the growing consumer protection measures being proposed and enacted in response to the new digital world. Consumer protection needs to keep up with the digital products and services now available, as well as the manner in which consumers can transact online. Living in an environment where devices and appliances in our homes, our cars and on our persons are connected, presents new challenges – who is responsible when your smart cooking app malfunctions resulting in a fire?
Our coverage includes:
- consumer rights in respect of digital products, including liability for defective products
- business to consumer contracts for the supply of digital content
- contracts for distance selling/online sales
- warranties and guarantees
- right to fair repair
Corporate Social Responsibility
Corporate Social Responsibility (CSR) concerns the responsibility of enterprises for their impact on society, and encourages sustainable growth. It promotes having a positive impact on both the people you deal with and environment in which you operate. In recent years having a clearly defined approach to CSR has become a core part of business strategy for companies.
CSR policy is subject to increasing mandatory requirements. In C2P, the CSR topic is covered under five categories:
- Environment: Carbon Footprinting, Climate Change, Environmental Health & Safety, Transboundary Movement of Hazardous Waste
- Ethics: Non-Financial Reporting Directive, Data Protection
- People: Consumer Protection, Occupational Health and Safety
- Products: Batteries, Circular Economy, Ecodesign and Energy Efficiency, Eco Labeling, Packaging, Product Safety, Prop 65, REACH, RoHS
- Supply Chain: Conflict Minerals, Illegal Logging, Modern Slavery, WEEE – e-Waste
Cybersecurity is the practice of ensuring protection against the criminal or unauthorized use of electronic data. This growing area of concern for companies is reflected in the growth of regulation in this area, with many countries laying down framework regulations establishing rules to protect consumers, society in general and governments from the different types of cyber vulnerabilities.
This topic encompasses regulations, proposed, enacted & in force, aimed at strengthening cybersecurity and supporting documentation along the lines of national strategies and guidelines. Regulatory & supporting measures on this topic will focus on the following themes:
- Cybersecurity for connected devices and IoT infrastructure
- Cybersecurity certification for ICT equipment
- National cybersecurity strategies
Compliance & Risks’ data protection and privacy regulations coverage relates to the protection of people with regard to the processing of personal data and rules relating to the free movement of this data.
Recent years have witnessed an unparalleled growth in data protection legislation, primarily as a knock-on effect from the sharp surge in mobile and consumer technologies. In particular, the lawful processing of personal data is quickly becoming a priority for so-called “smart appliances”.
Networked devices, capable of exchanging data, must be used in a such a way as to protect users from the risk of privacy breaches. Accordingly, this topic also covers data protection implications for connected products.
This topic covers the principal national data protection and privacy laws and regulations, both proposed and enacted focussing on:
- Collection, storage and use of data
- Fair and lawful data processing
- Individual’s rights
- Sharing of data
- Data transfer to other countries
- Data classification and quality of data security measures
- Measures to ensure the security of connected products
Ecodesign is an approach to designing products with special consideration given to the impact on the environment throughout its entire lifecycle.
Ecodesign regulates the design and use phase of the product by ensuring that products are manufactured to specific environmental technical criteria in order to minimize the environmental impact of the product throughout its life cycle. These specific criteria generally focus on power consumption and power management of a product. This can include setting maximum limits on power levels in off and standby modes and power management requirements such as automatically switching into standby after the shortest possible period of time.
Ecodesign may go beyond energy efficiency and include significant environmental aspects throughout the entire lifecycle of the product. These environmental aspects may relate to raw material selection and use; manufacturing; packaging, transport, and distribution; installation and maintenance; use; and end-of-life. In the European Union (EU), ecodesign regulations require the use of CE Marking and the preparation of a declaration of conformity.
Ecolabeling is about environmental certification and labeling done on a voluntary basis. Ecolabels ensure consumers can make informed purchasing choices allowing them to opt for products which are proven to be environmentally preferable overall to other products in the same category.
There are many different ecolabeling schemes included in this topic, such as Energy Star, EU Ecolabel, German Blue Angel, Taiwanese Green Mark Program; Nordic Swan Label.
Compliance & Risks’ EH&S Environmental legislation is a collection of many laws and regulations protecting the environment from harmful actions.
We focus on environmental laws and regulations aimed at reducing the impact of facilities on the physical environment like soil, climate, water supply and public health. Specific facility related requirements are usually recorded in an environmental permit.
The legislation imposes obligations on:
- Air emissions (pollutants/noise/odor/dust/light/radiation)
- Waste management (solid and hazardous waste; prevention, storage, transport, treatment)
- Water usage and discharge (sewage/effluent/stormwater and spills)
- Soil protection
- Hazardous material management (storage and handling)
- Energy management (energy use and efficiency)
- Emergency preparedness (prevention of and response to accidental release of chemicals/liquids/waste)
Subtopics of EH&S (Environment) include:
- Air including emissions, light, noise, odour and radiation pollution
- Chemicals in EH&S: Environment
- Electromagnetic Fields (EMF)
- Energy including its use, energy efficiency (of buildings/production processes) and renewable energy
- General – Emergency Preparedness & Response, Environmental Crime, Environmental Management Systems (EMS), Nature Protection, Spatial Planning and Development
- Pollution including soil pollution
- Waste including food and hazardous waste
- Water including its use, discharge, management and pollution
EH&S: Occupational Health & Safety
Compliance & Risks’ Occupational legislation is a collection of many laws and regulations protecting workers from exposure to hazards in the workplace.
Occupational Health & Safety (OHS), also commonly referred to as occupational safety and health (OSH) or workplace health and safety (WHS), is a multidisciplinary field concerned with protecting the safety, health, and wellbeing of people in the workplace from exposure to hazards resulting from work activities. The legislation imposes obligations on employers to:
- Examine and control workplace hazards
- Have operating procedures and communicate them so that employees follow safety and health requirements
- Provide safety training in a language and vocabulary workers can understand
- Use color codes, posters, labels or signs to warn employees of potential hazards
- Provide access to employee medical records and exposure records to employee or their authorized representatives
- Report and record all work-related fatalities and inpatient hospitalizations
- Be prepared for emergencies to prevent harm to workers and property
Subtopics of EH&S (Occupational Health & Safety) include:
- Electromagnetic Fields (EMF)
- General: Emergency Preparedness & Response
- Chemicals in EH&S: Occupational, Health & Safety
- Workplace Noise
- Workplace Radiation
Electromagnetic Compatibility (EMC)
Electromagnetic compatibility (EMC) legislation is intended to ensure that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance.
Such legislation limits electromagnetic emissions from equipment in order to ensure that, when used as intended, such equipment does not disturb radio and telecommunication, as well as other equipment. It also governs the immunity of such equipment to interference and seeks to ensure that this equipment is not disturbed by radio emissions, when used as intended
Electronic waste / E-waste / WEEE
Compliance & Risks’ coverage of electronic waste (e-waste)/waste electrical and electronic equipment (WEEE) provides a global perspective of compliance obligations, along with guidance documents, policy papers and commentaries from leading experts and international organizations.
WEEE or e-waste legislation aims to protect the environment and human health by ensuring that waste from electrical and electronic equipment (EEE) is properly managed. It includes requirements for the collection, storage, sorting, transport, treatment, preparation for reuse, recycling and disposal of WEEE.
These requirements typically apply to EEE including:
- Large household appliances
- Small household appliances
- Information Technology (IT) equipment
- Telecommunication equipment
- Lighting equipment
- Electrical and electronic tools
- Sports equipment
- Medical devices
- Monitoring and control instruments
- Automatic dispensers
- Gas discharge lamps
It is based on the principle of “extended producer responsibility” in that the responsibility for the management of WEEE is placed on producers that place EEE on the market. This means that manufacturers and importers must finance the collection, treatment, recycling and environmentally sound disposal of e-waste from their own products.
Manufacturers must also design and produce EEE that facilitates the re-use, dismantling and recovery of WEEE, its components and materials. This may include an obligation that the removal of certain parts which contain hazardous chemicals can be easily conducted to allow proper treatment or recovery.
WEEE regulations provide for separate waste collection and the marking of products with specific product labeling such as the “crossed out wheelie symbol,” indicating that EEE must not be thrown into general household or municipal waste or disposed to landfill.
Distributors or retailers may be required to take-back WEEE free of charge on a like for like basis which can entail setting up collection points to allow customers to take-back their products at their end-of-life.
To fulfill their financial, reporting, registration and other obligations producers may be required to either set up an individual waste scheme and submit a WEEE management plan, join a collective WEEE producer compliance scheme or participate in a product stewardship program, depending on the requirements in different countries and jurisdictions.
Energy efficiency regulations apply to energy-using and energy-related products which are defined as any good having an impact on energy consumption during use.
Minimum energy performance standards (MEPS) require products to meet a minimum level of energy performance before they are placed on the market. These standards aim to eliminate inefficient products from the market by prohibiting the sale of products that fail to meet a minimum performance level. Various jurisdictions have used mandatory MEPS as a means for setting energy efficiency requirements for their products to protect the environment by lowering energy consumption.
Energy efficiency labeling legislation enables consumers to make informed purchasing choices with regard to the energy consumption of their products by allowing them to compare the efficiency of a product with that of other makes and models.
These products must be supplied with an energy efficiency label and standard energy product information. The label will show the energy efficiency class of the product based on an energy scale. Information on the energy efficiency of the product must often be included in advertising and technical promotional material.
These laws may also require the label, energy efficiency information and supplier information to be registered in a central database for market surveillance purposes.
Compliance & Risks has been supporting clients in proactively planning and responding to the EU’s REACH Regulation since it was proposed.
The EU’s Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, commonly known as REACH, was enacted to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.
REACH applies to all chemical substances; not only those used in industrial processes but also in consumers’ day-to-day lives, for example in chemical products, such as household cleaning products and paints, as well as in articles, such as apparel, furniture and electrical and electronic equipment (EEE). Therefore, the Regulation has an impact on most companies across the EU, as well as affecting manufacturers exporting components to manufacturers based in the EU.
REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to the European Chemicals Agency (ECHA) how the substance can be safely used, and they must communicate the risk management measures to the users.
If the risks cannot be managed, authorities can restrict the use of substances in different ways. Annex XVII of the Regulation outlines restrictions on certain dangerous substances, mixtures and articles, including restrictions on:
- Asbestos fibers in articles;
- Benzene in toys;
- Cadmium in specified synthetic organic polymers;
- Chloroethene (vinyl chloride) as propellants in aerosols;
- Mercury in fever thermometers and other measuring devices, such as manometers, barometers, sphygmomanometers and thermometers other than fever thermometers;
- Polybromobiphenyls; Polybrominatedbiphenyls (PBB) in textile articles intended to come into contact with the skin;
- Tris (2,3 dibromopropyl) phosphate in textile articles intended to come into contact with the skin and
- Tris(aziridinyl)phosphinoxide in textile articles intended to come into contact with the skin.
EU Drinking Water Directive
The quality of drinking water in the EU is regulated by Directive 98/83/EC on the quality of water intended for human consumption, i.e. the Drinking Water Directive (DWD). The aim is the protection of human health from the adverse effects of any contamination of water intended for human consumption by ensuring it is both wholesome and clean. It applies to all water intended for human consumption apart from natural mineral waters and waters which are medicinal products.
Under the Directive Member States are obliged to:
- Take the necessary measures to ensure the water does not contain concentrations of microorganisms, parasites or harmful substances that could be a danger to human health, and meets minimum microbiological and chemical standards
- Ensure the standards are met when the water comes out of a tap or tanker
- Monitor the water regularly at agreed sampling points in order to check that the microbiological, chemical and indicator parameter values are met
- Investigate immediately when the standards are not met and take the necessary corrective action
- Ban or restrict a water supply if it is considered to be a potential threat to public health
- Inform the public when corrective action is taken
- Publish a report every 3 years on drinking water quality. This information for the public is sent to the European Commission
Food Contact Materials (FCM)
Regulations for food contact materials (FCMs) and articles typically require FCMs and articles to comply with good manufacturing practices (GMP), and to comply with restrictions or prohibitions on specific substances, so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could endanger human health; bring about an unacceptable change in the composition of the food or bring about a deterioration in the organoleptic properties of the food. Further, certain regulations also specify labeling and traceability requirements for FCMs.
Compliance & Risks’ covers regulations that apply to packaging and containers; kitchen appliances and equipment; cutlery, dishes and drinkware; which can be made from a variety of materials including glass, plastics, rubber, paper, wood and metal.
Globally Harmonized System (GHS)
The United Nations’ (UN) GHS is a system for standardizing and harmonizing the classification and labeling of chemicals.
The GHS is a logical and comprehensive approach to:
- Defining health, physical and environmental hazards of chemicals
- Creating classification processes that use available data on chemicals for comparison with the defined hazard criteria, and
- Communicating hazard information, as well as protective measures, on labels and Safety Data Sheets (SDS)
The GHS covers all hazardous chemicals. There are no complete exemptions from the scope of the GHS for a particular type of chemical or product. The term “chemical” is used broadly to include substances, products, mixtures, preparations, or any other terms that may be used by existing systems.
The basic goal of hazard communication is to ensure that employers, employees and the public are provided with adequate, practical, reliable and comprehensible information on the hazards of chemicals, so that they can take effective preventive and protective measure for their health and safety. Thus, implementation of effective hazard communication provides benefits for governments, companies, workers and members of the public.
The GHS identifies the intrinsic hazards found in chemical substances and mixtures and conveys hazard information about these hazards. Hazard statements, symbols and signal words have been standardized and harmonized and form an integrated hazard communication system.
Human Trafficking and Slavery (HTS)
Compliance & Risks monitors HTS regulations around the world. These regulations encompass the offences of slavery, servitude and forced/ compulsory labor in addition to human trafficking. They typically require retailers/ manufacturers to:
- Report their efforts to eradicate slavery from their supply chains. This reporting obligation only arises in some cases where entities meet a certain profit threshold
- Undertake due diligence on certain agents or contractors and for those contractors to provide a certification of compliance with anti-human trafficking rules
- Provide training on mitigating human trafficking for employees and management responsible for supply chains
- Audit their suppliers to determine compliance with company standards for human trafficking
- Certify that materials incorporated into a product comply with human trafficking laws
Compliance & Risks covers illegal logging regulations which typically impose obligations on importers and traders of wood and wood products to:
- Provide reports on product suppliers
- Maintain records of this information for a certain specified time frame and
- Affix CE Marking and other labels (if products fall within the EU Construction Products regime)
- Register (if products are treated with preservatives, this may create additional obligations under EU biocides or chemicals legislation)
Compliance & Risks helps its clients to ensure that the medical devices they bring to market are safe & compliant by providing up-to-date global coverage of laws and regulations, proposed, enacted & amended, as well as relevant standards, guidance documents, factsheets and more impacting the placing on the market of medical devices, including IVDs.
The topic encompasses:
- Definition and classification of medical devices
- Safety & efficacy / performance requirements
- Conformity assessment procedures
- Technical documentation
- Labeling and packaging
- Testing (clinical trial and evaluation)
- Provision of product information
- Record keeping
- Mandatory Unique Device Identification (UDI) mechanisms
- Quality Management Systems
- Requirements for qualified persons
- Post-market surveillance and consumer protection
Nanotechnology regulations aim to ensure that products containing nanoscale materials – including nanoparticles, nanoscale particles, nanomaterials, nanosized particles, nanosized materials, nano-objects and nanostructured materials – are manufactured and used in a manner that protects against unreasonable risks to human health and the environment.
Nanotechnology is a broad term used to describe the science of manipulating materials operating at a scale of 1 to 100 nm (1 billionth of a metre), i.e., nanomaterials. Nanomaterials may be used to exhibit characteristics such as increased strength, chemical reactivity or conductivity compared to the same material without nanoscale features.
Regarded as chemical substances under major global regulatory frameworks for chemicals, nanoscale materials are subject to the regulatory regime for the assessment and management of chemical substances. These include:
- Records keeping
- Safety data sheets, and
- Classification and labeling obligations, etc.
In the European Union (EU), nanomaterials are regulated by the REACH and CLP Regulations and a string of other regulatory instruments depending on the specific product, such as the Plastic Food Contact Material Regulation.
Additionally, certain EU Member States, including France, Norway, Denmark and Belgium have adopted mandatory reporting of nanomaterial or products containing nanomaterials to their national products register or nano register.
In the United States (US), under TSCA, manufacturers of new nanomaterials are required to submit a pre-manufacture notice to the Environmental Protection Agency (EPA) prior to manufacturing or importing of them.
In Canada, manufacturers and importers of nanomaterials must ensure that they are in compliance with the Canadian Environmental Protection Act, 1999 (CEPA) and requirements related to Significant New Activities (SNAcs).
Compliance & Risks constantly tracks changes to legislation in this area and provides expert news and analysis.
Non-Financial Reporting Directive (NFRD)
EU law requires large companies to disclose certain information on the way they operate and manage social and environmental challenges. Compliance & Risks’ monitors both regulations and guidance documents in relation to the Non-Financial Reporting Directive 2014/95/EU.
This Directive lays down the rules on disclosure of non-financial and diversity information by large companies and applies to large public-interest companies with more than 500 employees. Covered entities must publish reports on the policies they implement in relation to:
- environmental protection
- social responsibility and treatment of employees
- respect for human rights
- anti-corruption and bribery
- diversity on company boards (in terms of age, gender, educational and professional background)
The Directive gives companies flexibility regarding the format used to disclose the relevant information whereby companies may use international, European or national guidelines to produce their statements such as the UN Global Compact, the OECD Guidelines for Multinational Enterprises and ISO 26000.
Regulations concerning packaging and packaging waste management seek to provide a high level of environmental protection and in some instances, as within the EU, to remove barriers to trade.
They encourage the minimization and reuse of packaging, the reduction of landfill disposal of packaging waste and the support of the packaging waste recycling sector.
Packaging legislation covered by Compliance & Risks contain measures concerning, among other things, the:
- Concentration levels of heavy metals (lead, cadmium, mercury and hexavalent chromium) in packaging or its components
- Minimization of packaging volume and weight
- Design and composition of packaging in a manner that permits its reuse and recovery
- Extended producer responsibility (EPR) on the prevention and management of packaging at the end of its life cycle (collection, sorting, recycling, etc.).
Compliance & Risks offers a comprehensive collection of proposed, enacted and amended regulations and mandatory standards covering general product safety and safety of specific products globally.
The purpose of European Union’s (EU) Directive 2001/95/EC, commonly known as the General Product Safety Directive, or GPSD, is to ensure that products placed on the market are safe. The GPSD applies in the absence of other EU legislation, national standards, recommendations or codes of practice relating to safety of products.
Per the GPSD, businesses should place only products which are safe on the market. To that end, a number of European standards have been “harmonized” under the GPSD. Compliance with these standards demonstrates compliance with the safety requirements of the Directive. Additionally, the GPSD requires businesses to inform consumers of any risks associated with the products they supply and to ensure any dangerous products present on the market can be traced so they can be removed to avoid any risks to consumers.
Beyond the GPSD, specific rules exist for specific products, which are captured by Compliance & Risks, including electrical and electronic equipment (EEE), chemicals and toys.
Compliance & Risks maintains a close eye on this policy area tracking it on a worldwide basis and bringing news of developments to our clients on a timely basis.
Amid growing global concerns surrounding plastic pollution, single-use plastics, also known as disposable or problematic plastics, have become the focus of intense policy action. Despite their convenience provided in everyday life to businesses and consumers, their unitary lifespan has led to the proliferation of their waste within the environment.
Compliance & Risks’ Single-use Plastics topic is focused on laws, regulations and supporting sources aimed at discouraging, reducing and restricting single-use plastics within society. Measures adopted in dealing with the pollution of single-use plastics typically involve a combination of the following:
- Bans/restrictions on the manufacturing, importation, distribution and/or usage of single-use plastics
- Taxes or levies on their production or distribution (fixed or recommended)
- National consumption and reduction targets
- Extended producer responsibility (EPR) on the prevention and management of plastic products at the end of their life cycle (collection, management, sorting, etc.)
- Voluntary Industry Pacts
Textile, leather, fur and wool products are among the most regulated of all products, due to concerns such as:
- Proper care instructions, to ensure the consumer’s ability to maintain apparel
- Mislabeling of faux leather and fur as real leather and fur
- Restrictions on chemicals in direct and prolonged contact with the skin, like azo colorants, flame retardants, formaldehyde, heavy metals and phthalates
- Flammability of daywear and children’s sleepwear, and
- Physical hazards from drawstrings in children’s apparel
Our coverage encompasses the following product categories:
- Adult and children’s –
- Home textiles (bedding, curtains, oven mitts, towels, etc.)
- Upholstered furniture and furnishings (cushions and pillows, sofas and chairs, etc.)
- Mattresses and mattress pads
- Carpets and rugs
- Tents, and
And addresses newly-proposed, -enacted and -amended regulations and mandatory standards, from January 2016 on, including:
- Product Safety
- Testing and certification, and
Transboundary Movements of Hazardous Waste
This topic includes laws, conventions and regulations on the transboundary movement of hazardous waste which aim to protect human health and the environment by restricting the import, export and transit of hazardous waste.
These requirements aim to:
- Minimize hazardous waste generation
- Control and reduce international movement of hazardous waste
- Ensure that waste disposal and recovery is conducted in an environmentally sound manner as close as possible to the source, and
- Prevent and punish illegal traffic or trade of hazardous waste
The requirements mainly stem from the UN Basel Convention on the Control of Transboundary Movement of Hazardous Wastes and their Disposal of 1989 which defines and classifies hazardous waste, introduces a global regulatory control regime for the shipment of hazardous waste and other wastes and establishes worldwide notification requirements for the movement of hazardous waste.
Hazardous waste is essentially waste that contains dangerous properties that make it harmful to human health or the environment (for example waste that is explosive, flammable, toxic, etc.).
The primary legal requirements include:
- A prior notification procedure for the proposed shipment
- General information requirements
- Waste movement documentation
- Prior consent approval in the country of import or transit
- Marking and labelling of the waste
- Packaging of waste
- Import/export waste permits and licensing
- Proper waste disposal or recovery
Transport of Dangerous Goods
The Transport of Dangerous Goods topic covers regulations, laws and supporting documents which aim to prevent accidents resulting in injury to persons, damage to property and the environment.
Legislation for the transport of dangerous goods is directed towards businesses involved in the consignment, loading/unloading and carriage of dangerous goods by air, rail, road and water.
Goods are considered hazardous if they are explosive, corrosive, flammable, toxic or radioactive. Examples include: Lithium batteries; flammable liquids, gases and solids; substances liable to spontaneously combust; substances that emit flammable gases when in contact with water; oxidizing substances; toxic substances and corrosive substances. Notably, in the US, such articles and substances are classified as HazMats or hazardous materials.
Regulations concerning the Transport of Dangerous Goods focus on the following:
- Classification of dangerous goods
- Labeling of dangerous goods according to the UN number system
- Packaging and tank provisions
- Consignment procedures, labelling and marking of containers and vehicles
- Construction and testing of packaging, intermediate bulk containers (IBCs), large packages and tanks
- Conditions of carriage, loading, unloading and handling
- Vehicle crews, equipment, operation and documentation
- Construction and approval of vehicles, and
Legal duties normally apply to the consignor, the carrier, the driver, the crew, the packagers, the fillers, the loaders/unloaders, container operators, the consignee and dangerous goods safety advisers (DGSA).
Water efficiency is fast becoming a key policy issue and refers to the conservation of essential water resources, and achieving less water use in tandem with sustained appliance performance.
Whilst securing supply is a mainstay of the efficiency objective, water use also results in the emission of carbon, and as such constitutes an environmental threat.
Regulations are emerging to address the technological performance of household devices with regard to water and, initially at least, the implementation of voluntary labeling schemes for water-using electrical appliances. In some regions, mandatory water efficiency labeling programs, such as Singapore WELS, have now been instituted for certain home appliances.
Water efficiency regulations commonly include requirements for marking/labeling, registration, permits/licenses/approvals, providing product information, and payment of taxes, fees and duties.
The main product categories covered are:
- Washing machines
- Steam cookers
- Electric showers
Internet of Things (IoT)/wireless regulations establish licensing, certification and bandwidth requirements for devices that intentionally emit radiofrequency signals in the electromagnetic spectrum.
Compliance & Risks covers laws, regulations and supporting documents applying to radio frequency spectrum allocation, with a primary focus on unlicensed areas of the spectrum typically reserved to short range, low power devices, including:
- Wireless accessories
- Local area networking (LAN)
- Internet-connected appliances (IoT), and
- Radio frequency identification (RFID)
The content includes spectrum allocation tables and requirements for test standards, certification, registration, and approval. The covered devices typically use WiFi, Bluetooth, ZigBee or other low-power wireless communications standards.