Chemical registration

Chemical registration refers to the official registration of chemicals . Any manufacturer or importer, the Seine River in the scope of REACH falling substances placed on the market wants, must register these substances.

Registration according to the EU regulation REACH

Scope of REACH

Manufacturers or importers who place substances as such and / or substances in preparations with more than one tonne per year on the European market fall within the scope of REACH . A distinction is made between phase-in substances and non-phase-in substances for the term substance (see below).

Manufacturers / importers are natural or legal persons based in the European Community who manufacture a substance in the European Community or are responsible for importing it [Article 3 REACh-VO].

Manufacturers in the form of a natural or legal person based outside the Community who import substances, preparations and / or products into the Community can, by mutual agreement, appoint a natural or legal person based in the Community who, as their sole representative, is responsible for the obligations met for importers. If an only representative is named, the manufacturer outside the community informs the members of his supply chain resident within the community [Article 8 REACh-VO].

Phase-in substances are:

Substances that are listed in EINECS ;
No-longer polymers ;
Substances that have been manufactured in the EU but were not placed on the market by the manufacturer / importer in the 15 years before REACH came into force, e.g. B. in-house materials. (Corresponding evidence of the time of production and that the substances were not passed on to third parties must be available.)

All other substances are non-phase-in substances.

The following do not fall within the scope of REACh:

Polymers,
Waste,
Non-isolated intermediates,
Radioactive substances,
Substances in transit (customs surveillance).

In general, substances that are already adequately regulated by other legal regulations can be excluded completely (see above) or from parts of the REACh regulation.

The pre-registration

Pre-registration was only possible for phase-in substances (see above, scope) and was not mandatory. Manufacturers and importers will nevertheless carry out a pre-registration of their phase-in substances, since after December 1, 2008 the principle of “no data, no market” will apply. The manufacturers / importers are then no longer allowed to place their phase-in substances on the market until they have fully registered them and have a registration number.

In addition, manufacturers / importers received two major advantages through pre-registration. On the one hand, depending on the annual volume, they received a transition period (see table) for full registration. On the other hand, participation in a SIEF requires pre-registration.

Transitional periods according to Article 23 REACh-VO
Quantity band	Period from the entry into force	Expiry Date
${\ displaystyle \ geq}$ 1000 t / a	3.5 years	December 1, 2010
CMR substances 1 t / a ${\ displaystyle \ geq}$	3.5 years	December 1, 2010
Environmentally hazardous substances 100 t / a ${\ displaystyle \ geq}$	3.5 years	December 1, 2010
${\ displaystyle \ geq}$ 100 t / a	6 years	1st June 2013
${\ displaystyle \ geq}$ 1 t / a	11 years	June 1, 2018

SIEF stands for Substance Information Exchange Forum . It was the purpose of the pre-registration that the different manufacturers or importers of identical substances could find each other. Data on substance information are to be exchanged in the SIEF.

The pre-registration was done electronically to the EChA ( European Chemicals Agency , the European agency for chemical substances based in Helsinki) z. B. with the IUCLID 5 program and was free. The following data, which should already be available to the manufacturers / importers, had to be given during the pre-registration:

Identification of the substance, substance name and z. B. EINECS and CAS number ;
Name and address of the manufacturer / importer and the names of contact persons;
The envisaged deadlines for registration, ultimately the tonnage band (information is not binding);
Substance names that can be important for structural analogies.

The registration

Article 10 of the REACh regulation describes in general the information that has to be submitted for registration purposes. A technical dossier must be submitted using IUCLID 5 for all phase-in substances and non-phase-in substances from 1 t / a . In addition to the identity of the manufacturer / importer and the identity of the substance, the technical dossier must contain the following information:

Classification and labeling of the substance;
Information on manufacture and use (s) of the substance;
Guidelines on safe use of the substance;
Expert review (what information has been reviewed by an expert?);
Request for confidentiality of certain information;
Information on exposure (uses, routes of exposure, frequency of exposure);
Data set according to Annexes VII (quantities of substance> 1 t / a), VIII (quantities of substance> 10 t / a), IX (quantities of substance 10 to 100 t / a), X (quantities of substance 100 to 1000 t / a) and XI (quantities of substance> 1000 t / a);
Simple / qualified study summary.

The required data sets according to Annexes VII to X contain not only the physical and chemical properties but also information on toxicology and ecotoxicity.

Before a registrant attempts to meet the information requirements for registration, he must inquire within his SIEF whether a relevant study is available. Vertebrate studies should not be repeated.

New experiments to collect data are to be carried out in accordance with GLP (Good Laboratory Practice). Under certain conditions, which are described in Annex XI, tests can be omitted with justification. Corresponding waiving methods (e.g. data on substances of the same substance group or data from existing tests that were not carried out in accordance with GLP) must provide the required information.

REACh distinguishes between two types of study summaries. The simple study summary for substance quantities> 1 t / a contains the information in the respective Annexes VII to X with descriptions of the aim, method, result and conclusion of a study. With the simple study summary, the relevance of a study can be assessed. From a substance quantity of> 10 t / a, a qualified study summary must also be created. This should enable an independent evaluation of the study.

According to Article 10 b), a so-called Chemical Safety Report (CSR) is required for quantities of 10 t / a or more.

The core of the chemical safety report is the description of the exposure of a substance and its effect on humans and the environment. The assessments of the exposure and the effect result in a risk that must also be described for hazardous substances.

The chemical safety report requires communication within the supply chain. The know-how about exposure of a substance is mainly derived from its use and naturally lies more with the downstream user. The know-how about the effect of a substance and the risk management measures lies primarily with the manufacturer or importer.

Annex I of the REACh regulation describes the form and content of the chemical safety report. Accordingly, the chemical safety assessment comprises the following steps:

Determination of harmful effects on human health with the derivation of a DNEL value (Derived No-Effect Level);
Determination of harmful effects on human health through physico-chemical properties;
Determination of harmful effects on the environment with derivation of PNEC values (Predicted No-Effect Concentration) for the compartments water, soil, air as well as for the food chain and the microbiological activity in sewage treatment plants;
Determination of the PBT (persistent, bioaccumulating, toxic) and vPvB (very persistent, very bioaccumulating) properties.
Exposure assessment with development of one or more exposure scenario / s or, if necessary, development of relevant use and exposure categories;
Risk description.

Only if the manufacturer or importer concludes from steps 1 to 4 that the substance or preparation is to be classified as hazardous according to Directive 67/548 / EEC or as PBT or vPvB does the chemical safety assessment also include steps 5 and 6.

If the substance is not hazardous and cannot be assessed as PBT or vPvB, an exposure assessment and risk assessment are not required. The result of the chemical safety assessment must be documented in the chemical safety report.

An exposure scenario describes all conditions (e.g. during manufacture, processing, use and disposal) over the entire life of the substance. The exposure scenario also describes measures to control exposure to humans and the environment. These conditions of use and measures to control exposure are risk management measures in the broadest sense.

A use and exposure category is an exposure scenario that covers a wide range of processes and uses.

Registration according to the Chemicals Act old version

The Federal German Chemicals Act had, among other things, regulated the reporting, testing and, if applicable, labeling obligations and thus the registration of chemicals for new substances. These regulations mentioned in this section have meanwhile been replaced by those of the REACH regulation.

New substances were all substances that were not registered in the European List of Existing Substances ( EINECS ).

New substances were registered in the ELINCS directory.

Not all new substances were subject to the notification obligation, exceptions are possible for polymers, for substances in scientific research, for substances in process-oriented research and development and for quantities below 10 kg per year.

The Chemicals Act provided for registrations in a graduated form for each new substance that was marketed in quantities of 10 kg per year and more:

Gradations:
10 kg to <100 kg amount placed on the market per year
100 kg to <1,000 kg quantity placed on the market per year, or ≥ 500 kg total quantity placed on the market
≥ 1,000 kg quantity placed on the market per year, or ≥ 5,000 kg total quantity placed on the market
≥ 10,000 kg quantity placed on the market per year, or ≥ 50,000 kg total quantity placed on the market
≥ 100,000 kg quantity placed on the market per year, or ≥ 500,000 kg total quantity placed on the market
≥ 1,000,000 kg quantity placed on the market per year, or ≥ 5,000,000 kg total quantity placed on the market.

According to this gradation, the reporting types and deadlines stipulated in the Chemicals Act had to be complied with.

Some countries also have special chemical inventories: if they contain a substance, this substance may be placed on the market; if the substance is not included, it must be included in the respective inventory via a notification procedure (registration) or otherwise may not be used.

Examples of different chemical inventories

REACH - EU
AICS - Australian Inventory of Chemical Substances
DSL - Canadian Domestic Substances List
NDSL - Canadian Non-Domestic Substances List
KECL - Korean Existing Chemicals List
ENCS (MITI inventory) - Japanese Existing and New Chemical Substances (see Chemicals Law (Japan) )
PICCS - Philippine Inventory of Chemicals and Chemical Substances
TSCA - Toxic Substances Control Act (since 1976)
IECSC - Inventory of Existing Chemical Substances Produced or Imported in China
NECI - National Existing Chemical Inventory in Taiwan
NZIoC - New Zealand Inventory of Chemicals
Poison List - Swiss Poison Lists 1-3 (until 2005)

literature

Christian Calliess , Martina Lais: REACH revisited - The proposal for a regulation to reform chemical law as an example of a new European precautionary strategy . In nature and law. 27 (5), pp. 290-299 (2005), ISSN 0172-1631 .
Henning Friege: REACH - Registration, Evaluation and Authorization of Chemicals - level of information about the properties of chemicals controversial. In: Environmental sciences and pollutant research. 17 (3), p. 184 (2005), ISSN 0934-3504 .
Lothar Knopp: REACH versus "better regulation" and harmonization . In: Environmental and Planning Law. 25 (11 + 12), pp. 415-418 (2005), ISSN 0721-7390 .
Uwe Lahl, Katrin Anne Hawxwell: REACH - The New European Chemicals Law. In: Environmental Science & Technology . Pp. 7115-7121 (2006) ( doi: 10.1021 / es062984j ).
Steffi Richter, Dietline Großmann, Caroline Hoffmann (eds.): REACH for users . Brochure, 34 pages. Federal Environment Agency Dessau.
P. Brandhofer, K. Heitmann REACH - The new challenge for your company . Ecomed Verlag, ISBN 978-3-609-65104-0 .
M. Au, R. Rühl REACH regulation . Berlin, ISBN 978-3-503-10332-4 .
Boberski, Cornelia (Ed.), Forum Verlag REACH-Handbuch . Merching 2007, ISBN 978-3-86586-126-9 .
Karsten Aldenhövel: REACh declared! . Norderstedt 2007, ISBN 978-3-8334-9991-3 .
Fluck, Fischer, von Hahn: REACH + substance law . Berlin 2007, ISBN 978-3-939804-27-7 .