Assessment & Development and Training
In a globalized world, consumers can easily be made aware of issues related to poor conditions of production for a particular favourite brand and are demanding transparent information as an important element of decision-making when choosing a product.
In response to lobbying from responsible investors and consumers, buyers and distributors are steadily being encouraged to put in place their own solutions to evaluate the compliance of their products to the increasingly stringent local and international regulations and standards.
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals.
The REACH Regulation places responsibility on all consumer products producers and distributors to manage the risks from chemicals and to provide safety information on the substances.
In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in
articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.
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 the ECHA (European Chemicals Agency) in Helsinki 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. In the long run, the most hazardous substances should be substituted with less dangerous ones.
Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance.
ECHA receives and evaluates individual registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA's scientific committees assess whether the risks of substances can be managed.
Read more on the website of the European Commission
The key Provisions of the REACH Regulation include:
- Registration: Substances manufactured/imported over 1ton per year need to be registered with the European Chemical Agency (ECHA) by EU manufacturers and importers;
- Evaluation: Registration dossiers submitted will be examined by ECHA for its environment/public health impact;
- Authorization: Listed Substances of Very High Concern(SVHC) in Annex XIV are to be assessed and specifically allowed;
- Restriction: Restricted substances in Annex XVII to be assessed for restriction or even banned;
- Communication in the supply chain: Information about the safe use of chemicals should be communicated up- and downstream throughout the supply chain in the format of Safety Data Sheets, also called Chemical Safety Report or assessment.
Electrical and Electronic Equipment are subject to additional chemical requirements and regulations under the Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment. The main aim of this Directive is to restrict the use of certain hazardous substances that poses in danger environment and human health and aims to the different stakeholders to substitute the chemicals used by safer alternatives. The Chemicals restricted on the EEE are mainly heavy metals, Flame retardants and Phthalates that could be incorporated in any of the components of the EEE.
The legislative framework worldwide in what refer to Chemical restrictions and standards is increasing with the aim of providing safer products and alternatives on the manufacture. Some of the most important regulations worldwide are:
- EU Persistent Organic Pollutants Regulation (850/2004/EC – POP Regulation). The regulation prohibit and restrict certain substances that due to their resistance to photolytic, biological and chemical degradation can exist for centuries in our environment. Halogenated properties, low water solubility, high lipid solubility ,and semi-volatility, allow POPs to bio accumulate and bio magnify.
- EU Packaging and Packaging Waste Directive (Directive 94/62/EC). The EU Packaging and Packaging Waste Directive harmonized member state legislation regarding packaging material composition and the management of packaging waste. Composition of packaging material is addressed in a series of EU-wide standards. For the management of packaging waste through recycling targets and collection and recycling systems, member states have adopted voluntary marking. The directive also restricts the presence of certain heavy metals in the packaging.
- EU Batteries Directive (Directive 2006/66/EC). The Directive intends to contribute to the protection, preservation and improvement of the quality of the environment by minimizing the negative impact of batteries and accumulators and waste batteries and accumulators. It also ensures the smooth functioning of the internal market by harmonizing requirements as regards the placing on the market of batteries and accumulators. With some exceptions, it applies to all batteries and accumulators, no matter their chemical nature, size or design.
- US Toxics in Packaging Clearing House. The Model Toxics in Packaging Legislation was developed in 1989 to reduce the amount of four heavy metals in packaging and packaging components sold or distributed throughout the states. Legislation based on this Model has been adopted by 19 states. The legislation restrict the use of certain hazardous substances and requires that manufacturer, supplier and distributor to the purchaser must submit a certificate of compliance stating that a package or packaging component is in compliance with the requirements of the law.
- California Proposition 65. The Safe Drinking Water and Toxic Enforcement Act of 1986 (known as “Proposition 65”), was enacted as a ballot initiative in November 1986. The Proposition was intended by its authors 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.
Businesses are 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, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper. Once a chemical is listed, businesses have 12 months to comply with warning requirements.
Proposition 65 also prohibits companies that do business within California from knowingly discharging listed chemicals into sources of drinking water. Once a chemical is listed, businesses have 20 months to comply with the discharge prohibition
HENZ- Chemical Assessment tool, focused on Articles
HENZ is the out-of-the-box solution to assess your article’s REACH and SVHC compliance.
Eurofins Consumer Product Testing is proud to offer this excellent cost-saving, chemical assessment tool in close cooperation with CIRS
REACH Compliance & Chemical Assessment Tool - Global Overview
Concept and origin
HENZ is a full substance declaration tool and Restricted Substances List (RSL) inspection system for Articles compliance
Developed by CIRS in 2011 in partnership with Eurofins´ Consumer Product Testing Division it will enable our clients to face the challenges that current and future regulatory and market trends will impose upon them by:
HENZ – Why Chemical Assessment?
Full Analytical Testing Approach
By following this approach, your articles and materials are tested in laboratories in order to:
- Identify chemical hazardous substances presence
- Verify compliance with chemical regulatory requirements
Disadvantages of full analytical testing approach:
- High cost / Low Coverage
- Increased, and sometimes unpredictably extended testing time that might affect your deliveries.
- Sending high number of articles to labs to provide sufficient material
- Testing approach of the final product does not provide full visibility of whole supply chain.
Chemical Assessment Approach
Assessment of the likelihood of a material/component to contain certain hazardous chemical substances based on the BOM/BOS information provided by your suppliers.
- Review BOM/BOS information against all restricted substances lists (RSL), identify potential risk materials and potential presence of hazardous substances, previous to testing in a laboratory.
- Allows for targeted testing programs at laboratory focusing ONLY on materials, components and substances identified as likely to be present in products (Risk-based approach to reduce and optimize chemical testing).
- Chemical regulations drive the need to implement compliance and due diligence programs.
- Market trends are evolving and final consumers are demanding an increase in supply chain transparency as information regarding a product´s composition is being made accessible to them in order to influence purchase motivations
HENZ Solution main features:
- A Basic Substance database currently containing over 400,000 substances (including: names in CN/EN, CAS No. and EC No.)
- A Standard Material Database counting more than 50,000 material´s composition. Compiled using official databases, industry standards and formula books that help the user declare what substances may be present in their product.
- A Restricted Substance Database with over 100 chemical regulations and their restricted substances mainly focused (but not limited) to EU and US (Enables client´s to also define and include their own RSLs)
- Customizable reports that may:
- not only identify current restricted substances but also identify substances that will be restricted in the future
- Include actions to take by vendor according to client´s predefined CAPs or SOPs.
- The support of highly qualified personnel enabling:
- Customization where possible to client´s requirements
- Supplier workshops and trainings so as to assist in the program implementation
HENZ is a very useful tool in any of the production stages but its use in early stages helps companies and their suppliers to:
- Assess the product materials composition since its conception
- Assess different suppliers’ materials during sourcing stages
- Define possible actions to be taken from the beginning of the production chain
- Define the targeted testing program even before manufacturing the product
All this allows companies to implement a cost-effective and time saving solution to manage supply chain
HENZ- Process Workflow
Preparation and submission of information of hazardous mixtures placed on the market to the Spanish and Portuguese poison centres.
This service includes:
- Preparation of the toxicological file or sheet
- Submission of notification to INTCF or INCAV
- Payment of fees and support
Creating and updating safety data sheets for Spanish/Portuguese regulatory compliance from the data provided by the client.
Translation of a SDS to Spanish/Portuguese from English
Materials in contact with drinking water:
Eurofins provides toxicological assessments of raw materials which have to be tested according to the Danish regulation for building components to come into contact with drinking water (GDV regulation). These toxicological assessments can also be performed according to the German UBA guidelines for materials and components to come into contact with drinking water.
For all products that have to come into contact with drinking water (e.g. hoses, water taps etc.) there is a requirement that the composition of the raw materials (e.g. plastic rubber etc.) has to be evaluated and subsequently substances with specific migration limit in these materials have to be tested by migration testing into water.
Service for Cosmetics from Eurofins EVIC France:
Review of available safety data from the literature and the supplier’s data (each endpoint is analyzed: skin and eye irritation, sensitization, mutagenicity, systemic toxicity). Determination of the pivotal study and the reference value/NOAEL.