Certification of CE conformity is an identification marking in accordance with European Union legislation for a large number of industrial products.
The labelling obligation arises from diverse sets of rules for various product groups:
The objective of CE labelling is to ensure that the consumer receives a standardized safe product. Liability for the safe use of the industrial product rests with the manufacturer or importer of the product.
It is therefore important for the entrepreneur and manufacturer to apply all specifications relevant to the product from the directives and their regulations transposed into national legislation. We provide expert and constructive support for customer enterprises right up to the time the product is placed on the market. This ensures extensive adherence to the required CE conformity.
Special laws on ensuring the environmentally compatible disposal of wastes create new obligations for manufacturers and users. In addition to the Verpackungsverordnung (Packaging Ordinance), the Electrical and Electronic Equipment Act and the Batteriegesetz (Battery Act) must be complied with. Particularly manufacturers of items that come under these laws need to comply with manifold registration, notification, labelling and reporting obligations, as well as substance bans.
In order to minimize the costs incurred, a check needs to be performed to see which products actually come under the Electrical and Electronic Equipment Act or the Battery Act. In addition, the legal assessment of exemption provisions and cases of doubt is particularly important for avoiding risks and ensuring product safety.
The European legislation on chemicals and hazardous substances and the REACH Directive confront small and medium-sized enterprises with new challenges again and again, requiring intensive preoccupation with this topic.
For example, candidate lists must be observed and required actions defined for the chemicals used in a company. In parallel with this, new labelling regulations from the area of the globally harmonized system for classifying and labelling chemicals (GHS) must be implemented.
In this complex environment, we support our customers as an expert liaison partner, who not only takes the current status into account, but also intensively monitors future developments.
The so-called RoHS Directive (Directive 2011/65/EU), previously (Directive 2002/95/EC), defines the restriction of the use of hazardous substances in electrical and electronic equipment. The Directive was implemented in Germany by means of the Elektro- und Elektronikgeräte-Stoff-Verordnung (German Electrical and Electronic Equipment Substances Ordinance - ElektroStoffV).
The ElektroStoffV affects manufacturers and importers of household appliances, IT and consumer electronics, electric tools, toys as well as sports and leisure equipment, medical appliances, monitoring and control equipment.
Electrical equipment, for example, may be placed on the market only if certain substances like lead, mercury, hexavalent chromium, polybrominated biphenyl (PBB) or polybrominated diphenyl ether (PBDE) or cadmium have been largely avoided.
Furthermore, technical documentation must be prepared, internal production inspections implemented, an EC Declaration of Conformity issued and CE marking affixed to the product. This already needs to be done today for products for which requirements had also been defined in the previous RoHS Directive. Transition periods no longer apply to these products.
If a product could not hitherto be assigned to an equipment category in accordance with RoHS, companies need to check the category to which the products are to be assigned based on the new scope. This means that all electrical and electronic equipment will have been recorded. This also applies to those products for which the electrical function may not be the primary function.
Once the category has been defined, companies then need to check the date from which RoHS is to apply to this category. If your product were assignable, say, to the new category 11 (other electrical and electronic equipment not covered by any of the categories above), the ROHS Directive would need to be applied from 22 August 2019 onwards, i.e. the technical documentation including the EC Certificate of Conformity would need to exist for the product from this point in time onwards.
BfU provides support, in the context of product compliance, in identifying the requirements for your electrical products and in formulating required measures, assisting you with the implementation process.
A life cycle assessment (LCA) enables all environmental impacts (e.g. emissions) of a product to be systematically analysed and assessed over its life cycle. This includes resource extraction, energy provision, manufacture of the product, transport services, as well as the use and disposal of the product.
An LCA enables
An LCA therefore provides the basis for
According to DIN EN ISO 14040 "Environmental Management – Life Cycle Assessment", an LCA comprises the following elements:
Instead of a product (product life cycle assessment), a process (process life cycle assessment) or an entire company (corporate life cycle assessment) can also be analysed.
The aim of every life cycle assessment is to provide a quantitative recording of the environmental situation and to use the results to derive measures for reducing the environmental pollution caused by the product, process or company. A comparison of different products and services is also possible.
We will be pleased to assist you in using a life cycle assessment to analyse and assess the environmental impacts of your products/processes/company.
As an additional step we compile Environmental Product Declaration (EPDs) according to DIN EN ISO 14025 „Umweltkennzeichnungen und -deklarationen - Typ III Umweltdeklarationen - Grundsätze und Verfahren (ISO 14025:2006); Deutsche und Englische Fassung EN ISO 14025:2011“ for your products or, in case they are building products, according to DIN EN 15804 „Nachhaltigkeit von Bauwerken- Umweltproduktdeklarationen- Grundregeln für die Produktkategorie Bauprodukte; Deutsche Fassung EN 15804:2012+A1:2013“.
We transfer the results of the LCA into the necessary reports (background report and EPD-report) and support you regarding the verification process. Here we consider the general principles as well as the specific regulations for the product group (Product Categoy Rules - PCR) of the "Institut für Bauen und Umwelt e.V. (IBU)".
A safety data sheet (SDS) provides all information that users need in order to handle chemicals professionally. This includes detailed information on the composition of the product, on possible hazards and on safe handling, storage and transport.
Who needs to prepare an SDS?
When does an SDS need to be prepared for a product?
Under Article 31 of the REACH Regulation, the supplier of a substance or a mixture must provide the recipient with a safety data sheet if
A user may also request a safety data sheet where a mixture does not meet the criteria for classification as dangerous, but
What requirements on safety data sheets must be complied with?
Requirements on safety data sheets are defined by Regulation (EC) No 1907/2006 (REACH), particularly by Article 31 in conjunction with Annex II.
Safety data sheets must be updated in accordance with the REACH Regulation if, for example, there have been changes to classification and identification, evidence of hazards in terms of carcinogenicity, mutagenicity or toxicity for reproduction exists or new limit value classifications are made.
The safety data sheet must be supplied to the recipient in an official language of the relevant country in which the substance or mixture is placed on the market, unless the Member State concerned provides otherwise.
The supplier of a product is responsible for ensuring that the safety data sheet is technically correct and complete. It is important that this document should be regularly brought into line with the latest developments in knowledge.
Safety data sheets must be prepared by experts.
Our interdisciplinary team will be pleased to prepare safety data sheets for your products and update your existing safety data sheets.
We prepare our safety data sheets on the basis of the REACH Regulation, being guided by "Guidance on the Preparation of Safety Data Sheets", issued by the European Chemicals Agency (ECHA), and by Notification 220, "Safety Data Sheet", issued by the Federal Ministry for Labour and Social Affairs (BMAS), which provides assistance with preparation of sections of the data sheet in which national specifications and insights must be taken into account or to which the guidance provided by ECHA does not refer.
Further information on requirements and prerequisites as well as on extended data sheets is available here.
As a result of a large number of European regulations and their national implementation, such as the REACH Regulation, the RoHS II Directive (implementation via the Elektro- und Elektronikgeräte-Stoff-Verordnung (German Electrical and Electronic Equipment Substances Ordinance - ElektroStoffV)), the Battery Directive (implementation via the Batteriegesetz (German Batteries Act - BattG)), the Ecodesign Directive (implementation via the Energieverbrauchsrelevante-Produkte-Gesetz (the German Energy-Related Products Act - EPVG)) etc., manufacturers, importers and even retailers are being called upon, on the one hand, to carry out labelling and the corresponding certification as part of product and user safety in accordance with the statutory provisions and, on the other hand, to ensure that substance restrictions and bans are complied with.
The statutory regulations describe general obligations for economic operators and define requirements for CE marking (where necessary). Manufacturers and importers are under an obligation to take necessary measures in order to ensure that only products that comply with the applicable statutory regulations come onto the market.
This presents many companies with major challenges due to the complexity of constantly changing regulations.
We support companies on the way to making their products available on the European market in a legally certain manner. To this end, we offer comprehensive marketability studies in the form of product compliance assessments. As part of these assessments, the product is analyzed in its actual state so as to derive measures that are necessary to enable the product ultimately to be placed on the market in a legally certain manner.
The marketability studies that we carry out comprise the following services, which we tailor to the individual products in consultation with our customers: