Implementation of the new chemicals legislation
The regulation (EC) Nr. 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) places high demands on all companies, traders and educational institutions that produce, import, trade or use chemical substances and mixtures.
With effect from 1 June 2007, the European Union has rearranged the chemicals legislation with the entry into force of the REACH regulation to ensure the safe handling of chemicals from manufacturing to disposal. The regulation (EC) 1907/2006 includes the registration, evaluation, authorisation and restriction of chemical substances. REACH applies to all actors in the supply chain - the manufacturer, distributor, trader through to the downstream users of chemicals - and applies to almost all chemical substances on their own or in mixtures whether or not they have hazardous properties. Products are affected by REACH if they release substances or contain substances of very high concern (SVHC).
Manufacturers and importers are required to provide certain information on their substances and to prove that during the intended use of their substances no danger to humans and the environment will occur.
A chemical substance on his own, in mixtures or in products may only be manufactured or placed on the market in the European Community if it is registered with the European Chemicals Agency (ECHA). REACH affects all environmental and occupational health and safety related issues. The focus here is to check the requirements for risk management and its impact on the internal operations.
- Protection of human health and the environment from potential chemical hazard
- Improved risk management in handling and processing of chemicals
- Promoting innovation and competitiveness of the chemical industry in the EU
- Transferring responsibility for risk assessment from the authorities to the manufacturer
- At the same time the free circulation of substances on the internal market and also the competitiveness and innovation shall be improved.
Aug. Hedinger strongly supports the aims of REACH: To ensure a high level of protection for human health and the environment and to promote alternative methods for assessment of dangers posed by substances.
We understand REACH as part of an increasing general trend of regulation with the aim to ensure sustainable development, production and use of chemicals. Aug. Hedinger endeavors in close cooperation with customers and suppliers, the REACH implementation as smooth as possible.
To ensure the availability of our current product range for our customers and to ensure that the products we use and all materials supplied to us are also compliant with REACH, we are in constant contact with our suppliers. We continuously review our product range to ensure compliance with the specific requirements of the REACH regulation.
What are consequences of REACH
- All substances from 1 t/a production or import volume must be registered with the European Agency for chemical substances ECHA in Helsinki.
- For all substances from 1 t/a a technical dossier must be created.
- From 10 t/a a chemical safety report must be created.
- Data requirements according to annexes VII - X of the REACH regulations increase with the production and import volume:
1 - 10 t/a: Annex VII
10 - 100 t/a: Annex VII + VIII
100 - 1000 t/a: Annexes VII - IX
>1000 t/a: Annexes VII - X
No data - no market.
Do all substances need to be registered?
Substances which are produced or imported in a quantity of 1 tonne and more per year in the EU are subject to registration. REACH affects not only hazardous materials, but with the following mentioned exceptions all chemicals. Exceptions are: polymers, radioactive substances, substances under customs supervision, non-isolated intermediates, waste, medicinal products for human and veterinary use, substances in food and feed, food additives, flavourings, re-imports of registered substances and substances of annex IV and V of the REACH regulation, such as water, starch, sugars, oils.
The registration deadlines and requirements for the registration dossiers depend on the manufactured or imported quantities and properties of the chemical substances. The following deadlines are to observe:
 CMR: carcinogenic, mutagenic, toxic for reproduction
 R50/53: "very toxic to to aquatic organisms, may cause long-term adverse effects in waters"
 Phase-in substance:
- Substance listed in EINECS (European inventory of existing commercial chemical substances; List of substances that were prior to 1981 on the market ["old substances"])
- A substance made in the EU, but not placed on the market by the manufacturer/importer in the 15 years before the entry into force of REACH (for example internal substances)
- A so-called "No-longer polymer", that means a substance which was classified until the beginning of the 1990s (entry into force of the 7. amending Directive) as a polymer
The REACH registration number assigned by the ECHA as far as the registration dossier permits, must be indicated on the material safety data sheet (MSDS) (Regulation (EU) 435/2010 3.2.4). The substance registration will therefore usually lead to an updated safety data sheet containing the REACH registration number.
Aug. Hedinger updates its safety data sheets immediately after the registration number was announced by the supplier and provides this to its customers promptly.
Communication along the supply chain - safety for all identified uses
One key element of the REACH Regulation is the identification of uses and the identification and assessment of potential exposure scenarios.
The REACH legislation provides a number of new requirements for the uses of chemical substances and the associated communication between suppliers and customers. One of these requirements is to prove the "safe use". This means that the registrant of a substance required to registration, collects all uses of the concerned substance known to him, or announced by customers and include these uses in his "Chemical Safety Assessment" (CSA). These uses become through this process "identified" uses.
In the "Chemical Safety Assessment", the manufacturer / importer must prove that the use of a substance during its entire life cycle (production, processing, end-use, disposal) is secure. The result of this evaluation process is a series of conditions for the processing of the substances, as well as risk management measures, concerning the safe use of the substances.
These information are documented in the so called exposure scenarios that are communicated after the registration by the extended safety data sheets (eSDS) to downstream users. The identification of all uses is a huge challenge. The reasons are the variety of substances to be registered, and their uses and the amount of companies that are involved in the communication chain.
When will the downstream user receive an extended safety data sheet with exposure scenarios?Availability of registration numbers and exposure scenarios
In addition to the known 16 sections of the MSDS, the eSDS contains the REACH registration number, information on the restriction of uses relating to the approval requirement where applicable and identified uses as appendix in the form of exposure scenarios. Only for these identified uses the substance may be used in future. The downstream user has also the possibility to prepare a chemical safety report and the resulting exposure scenarios of his own if its uses are not shown in the received exposure scenarios, or if the risk management measures and/or other specified in the exposure scenarios are not consistent with those used in his operation. These must be submitted in any case the European Chemicals Agency for review.
The eSDS should enable the downstream users in a position to use his material safely.
In our capacity as a downstream user the review of exposure scenarios and requirements for risk management measures after receiving an eSDS is performed consistently by Aug. Hedinger and in case of deviations appropriate measures are implemented. As well we provide our customers these current eSDS.
We would like to ask our customers to check their uses of the products in the relevant extended safety data sheets. Missing uses or requirements in the exposure scenarios that do not comply with the own using parameters must be reported within one year after receipt of the eSDS on the supplier or manufacturer.
Candidate list - SVHC - Substances of very high concern
REACH foresees a special authorisation procedure (authorisation) for substances that are of particular concern for scientific evaluation. These include carcinogenic, mutagenic, toxic to reproduction substances (CMR), persistent, accumulating and toxic substances (PBT) and very persistent, very bio-accumulating substances (vPvB). The inclusion of a substance in the so-called "candidate list" according to article 59(1) of REACH raises a number of obligations.Article 31(1) of REACH requires among other things the supplier of a substance has been included in the "candidate list", to provide its customers a safety data sheet. The supplier of a mixture containing ≥ 0,1% (w/w) of SVHC, provides a safety data sheet on request of its customer (article 31(3b) of the REACH regulation).
Furthermore Article 33 of REACH the supplier of a product that contains a substance from the "candidate list" at a concentration of more than 0.1% (w/w) has to specify at least the names of the relevant substance to his customer.
To help our customers to comply with this obligation, we check in every shot of new substances in the "candidate list" whether our product portfolio contains such substances.
The European Commission in the comitology procedure decides on the acceptance of a substance from the list of candidates in the annex XIV (list of substances subject to authorisation) after a comment period.
Annex XIV - list of substances subject to authorisation
After the inclusion in annex XIV the substance subject to authorisation is provided with an expiry date. This expiration date is 3.5 to 4 years after inclusion of the substance in annex XIV. Thereafter the substance without authorisation may not be placed on the market nor used. Moreover a date is set at least 18 months before the expiry date's, until an appropriate application for admission must be submitted. Only then it is possible to use the substance subject to authorisation even after the deadline or to place it on the market. The application for authorisation has to be submitted to ECHA. Producers, importers as well as downstream users can submit an application. The Commission decides on the applications for approval. Annex XIV contains the possibility that certain uses of the substance are excluded from the authorisation requirement.