Regulatory Compliance

The REACH Regulation controls the manufacture, import and use of chemicals throughout Europe and impacts not only EU companies but also those around the world, either directly or indirectly. Companies are obliged to identify the risks associated with the substances they produce and import into the EU market, and to undertake a risk assessment for human health and the environment.

In accordance with REACH, non-EU manufacturers must have an Only Representative (OR) within the EU for the registration process. All ‘non-exempt’ chemical substances produced in the EU or imported into the EU in volumes ‘greater than one tonne per annum’ must be registered with the European Chemicals Agency (ECHA). Colloids only use raw materials that are REACH-registered or exempt from the legislation – this is a legal requirement.

REACH if we leave the EU

Colloids fully understand any concerns surrounding REACH and Brexit and are continually monitoring the regulatory landscape to keep abreast of the developments, as they arise. The current understanding is that the UK has committed to ensure that UK legislation will replace EU legislation and establish a regulatory framework with the domestic capacity to deliver the functions currently performed by ECHA. There is likely to be no change regarding GHS and CLP.

Colloids are continuing with our duty to ensure that we comply with all chemical regulations regardless of the status of Brexit negotiations.

We are in continuous and active discussions with our suppliers and customers regarding the potential adjustments to the regulatory requirements and are monitoring the situation regarding continued supply and the possibility of the services of UK ORs in the supply chain. Colloids will also work with our European suppliers to facilitate the registration of their raw materials on the new UK REACH system. Initially this will be a basic transfer of information with full dossier information being required within two years.

To protect human health and the environment from harmful chemicals, prohibition and restriction of certain SVHCs (Substances of Very High Concern) are in place. In Europe, the REACH Regulation governs the use of SVHCs. These substances are placed on the Candidate List for future inclusion in REACH Annex XIV (Authorisation List). It is a requirement that companies must inform subsequent parties in the supply chain about this status and any SVHCs present.

A major issue for article suppliers is how to determine if their final finished goods contain any of the Candidate List SVHCs. SVHCs can be present in a range of consumer products but manufacturers and retailers can sometimes not be aware of their presence. Colloids are aware that our customers will be invested in how their products might be affected and what the prospect is of them containing any of the current or proposed SVHCs.

Colloids assess all chemicals present in our products and can issue statements to declare SVHC-free compliance; for clear communication throughout the supply chain.

Restrictions and prohibitions of supplied products also exist at industry-specific levels. This can be seen, for instance, in the automotive industry, with the GADSL list. Colloids can issue declarations to confirm that its products do not contain any substances listed on the current GADSL list.

The EU Directive on Packaging and Packaging Waste (94/62/EC) sets out the requirements that all items of packaging must meet before being placed on the market. The measures are aimed at preventing the production of packaging waste, the reuse of packaging and recycling.

The legislation restricts the presence of the following heavy metals in packaging – lead, cadmium, mercury and hexavalent chromium – with the goal of protecting the environment from hazardous substances and materials. Harmful substances in packaging must be minimised to reduce or remove emissions from incineration or landfill.

Colloids can supply confirmation that its masterbatches used in the manufacture of packaging support the EC Council Directive on Packaging Waste 94/62/EC through disclosure that they do not contain any intentionally added, nor any significant contamination levels of the above mentioned restricted hazardous substances.

The Packaging and Packaging Waste Directive also requires that the packaging of a product indicates the nature of the materials used for the packaging in order to facilitate classification for recycling and re-use purposes. Where relevant/requested, all Colloids products can meet the Packaging Directive requirements. Our own products are of course also packed in compliant packaging and all relevant markings are placed on Colloids packaging to aid recycling identification.

Directive 2000/53/EC on end-of-life vehicles details the measurements to prevent and limit waste from end-of-life vehicles (ELVs) and their components and ensures that where possible they are reused, recycled or recovered.

The Directive covers the restriction of the use of certain hazardous substances (lead, cadmium, mercury and hexavalent chromium).

Colloids are in compliance with the ELV Directive. The above-mentioned substances are not intentionally introduced to the manufacturing process. Therefore, our products are not known to contain any of these heavy metals with the exception of technically unavoidable traces.

The EU’s RoHS (Restriction of Hazardous Substances) also known as Directive 2002/95/EC restricts the use of specific hazardous materials found in electrical and electronic products.

Substances banned under RoHS are lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers and four different phthalates (DEHP, BBP, BBP, DIBP).

These chemicals are hazardous to the environment and pollute landfills. They are also human health hazards in concern to possible occupational exposure during manufacturing and recycling.

Colloids can provide RoHS compliant declarations for communication down the supply chain.

Global Chemical Inventories list chemicals that are authorised to be manufactured in or imported into a specific country. The main objective of these inventories is to provide a primary initiation towards comprehensive legislation by assessing the information reported to the responsible authorities by manufacturers, processors and users. If a Chemical Inventory exists for a certain country, a substance may be produced and imported in that country only if it is listed.

The main Current Global Chemical Inventories are; Australia, Australian Inventory of Chemical Substances (AICS); Canada, Domestic Substances List (DSL); China, Inventory of Existing Chemical Substances in China (IECSC); Europe, European List of Notified Chemical Substances (ELINCS); Japan, Existing and New Chemical Substances Inventory (ENCS); Korea, Korea Existing Chemicals Inventory (KECI); New Zealand, New Zealand Inventory of Chemicals (NZIoC); Philippines, Philippine Inventory of Chemicals and Chemical Substances (PICCS); U.S.A, Toxic Substances Control Act (TSCA).

Chemical Inventories currently in the process of being implemented include Brazil, India and Malaysia.

Colloids can provide comprehensive declarations on the Global Chemical Inventory status of all its products.

The Safety Data Sheet (SDS) is a vital document as its main function is to transfer safety information down the supply chain. SDSs detail any Hazardous Chemical present in the product, Protective Measures necessary, Health Risks, First Aid, Environmental Risks, Physical Data, Transport classifications and Disposal information, amongst many others.

Manufacturers and suppliers are obliged to provide customers with Safety Data Sheets. Colloids supplies SDSs for all products, in various languages and in country-specific formats such as EU, USA, and China.

Food contact materials (FCMs) have become subject to an increasing number of regulations worldwide. Certain countries have their own legislations regarding Food Contact materials. However, the basic principles, procedures and legislation are similar globally. Common features of all Food Contact legislation are the prohibition of materials that transfer chemicals to food in concentrations hazardous to human health and those that adversely affect the sensory properties of food. Compliance with these must be guaranteed from the manufacturer right down to the user.

Based on compliance statements provided by our suppliers, Colloids can supply DoFCs that will detail compliance with EU Regulations, specific migration limits, FDA and Chinese legislation for use in food contact applications, subject to restrictions and maximum addition levels where applicable. It continues to be the obligation of the manufacturers to comply with the safety standards. However, Colloids will support and issue DoFC Indicative reports, where applicable, to aid in the eventual compliance of our customers’ finished Food Contact articles.

The general provisions of the EU Toy Safety Directive define what constitutes a toy, provide technical documentation requirements, establish production controls, detail physical hazards and chemical hazards and more. Chemical requirements of the EU Toy Safety Directive include restrictions on toxic elements and the use of CMR chemicals. Certain Heavy Metals can cause a range of harmful health effects, from respiratory disorders to neurological issues. Heavy metals testing in toys and safety requirements have become ever more severe in recent years.

EN71-3 Migration of Certain Elements is the recognised standard prescribed by the Toy Safety Directive. It is an initial screening that looks at the total migration of Heavy Metals from toy materials and from parts of toys. EN71-3 restricts the amount of lead and eighteen additional other toxic elements, which can be as severe or even more harmful than lead. It is a legal requirement for any product which is to be sold as a toy inside the EU. Previously only EN71-3 has been used to analyse these risks but this is limited as it only considers risks presented via ingestion. EN71 parts 9 – 11 address this limitation by evaluating the risks from more than 80 substances, such as solvents and preservatives, that could cause harm from contact, swallowing or inhalation.

In the US all toys must meet the safety requirements of ASTM F963 as set out in the Consumer Product Safety Improvement Act (CPSIA). The toy industry has worked to make this and the EU directive functionally equivalent on most key attributes.

The standard includes requirements and test methods related to physical attributes, small parts, chemical and material safety, batteries, and more; its main aim is to reduce the safety hazards of toys. Chemical requirements set out limits for toxic chemicals, including cadmium, lead, mercury and phthalates.

Raw material quality control is vital to ensure compliance and Colloids understand that transparency and accountability in a supplier chain is imperative. The obligation lies on manufacturers and importers of the toys to comply with the safety standards. However, Colloids will support and issue Toy Safety Indicative reports, where applicable, to aid in the eventual compliance of our customers’ finished toy articles.