Chemreach GmbH - REACH Regulation Service

Chemreach GmbH

REACH Regulation

REACH is a Regulation (EC) No 1907 of the European Parliament and of the Council of 18 December 2006, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH regulation entered into force on June 1st 2007. The purpose of this regulation is to ensure a high level of protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry and innovation. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. This Regulation lays down provisions on substances and mixtures. The regulation applies in all EU countries plus Norway, Iceland and Liechtenstein.

Almost all the chemical substances marketed in quantities over 1 tonne per year should be registered under REACH, unless they are explicitly exempted. Polymers themselves are exempted, but their monomer and most of the additives are in scope of REACH.

Our REACH Services

Chemreach GmbH provides a comprehensive range of technical and administrative registration services for chemical substances under EU REACH Regulation:

REACH Consulting Service: We offer consulting service in REACH regulatory affairs. Our REACH specialists provide customized REACH registration strategy/solution and assist chemical companies efficiently in compliance with REACH regulation.
REACH Registration: Literature search, Analysis of data gap and data adaptation/waiving; Evaluation of analytical methods and results of your products; Generation of IUCLID Dossier for member registration and individual registration; Submission of IUCLID dossier via REACH-IT jointly or individually; Coordination of data sharing for Letter of Access; Management of SIEF agreement.
Preparation of Chemical Safety Report (CSR) and Exposure Scenario (ES): Generation of Chemical Safety Report for tonnages above 10 t/a; Generation of Downstream User CSR; Generation of Exposure Scenario for dangerous substance, PBT and vPvB substance, Generation of ES for identified uses not covered in registrant's Dossier.
REACH Only Representative (OR) service: We offer a comprehensive OR service package for non-EU companies that manufacture or formulate chemical substances and mixtures. We have been a REACH OR since 2008, the year REACH was introduced in EU. As an OR, we will fulfill the registration obligation of importers under REACH which will relieve the EU importers within the same supply chain from their registration obligation.
Management of REACH consortium and Third-Party Representative service: We offer REACH consortium and third-party representative services to chemical manufacturers and importers in the EU. We represent you within the SIEFs and consortia and keep your data confidential. We pre-register and register your chemicals under our own legal entity, your company can stay anonymous for the public under REACH.
REACH CoRAP and authorization service: For substance in CoRAP list, EU authority may request additional data during the process of substance/dossier evaluation; Substances in authorisation list are subject to authorisation. We offer comprehensive service along CoRAP and authorisation processes.
Preparation of Chemical Safety Report (CSR) and Exposure Scenario (ES): Generation of Chemical Safety Report for tonnages above 10 t/a; Generation of Downstream User CSR; Generation of Exposure Scenario for dangerous substance, PBT and vPvB substance, Generation of ES for identified uses not covered in registrant's Dossier.
One-Stop REACH Service: We provide a comprehensive one-Stop REACH service. Our service is tailored to our customer’s needs from consultancy to the completeness of the REACH registration. We continue to keep your registration active and updated after successful registration, we help you update your registration for instance with updated tonnage, updated company size, or new information. We also provide service to compile safety data sheet or extended safety data sheet in all European languages.
Compilation of REACH Compliance Declaration & Statement Service: REACH written declarations/ statements are often required along the supply chain. The typical concerns may often refer to the statement of substances in article and specially the substances in SVHC list. Our service is to help you compile your REACH declaration according to REACH regulation.
REACH Certificate as your OR: We provide Certificate of REACH compliance for your product after successful registration. The certificate indicates the necessary REACH compliance information, such as registration number and other relevant information. The certificate confirms that we have registered your products as your Only Representative and your EU-customers become downstream users in accordance with REACH. We also provide REACH tonnage coverage certificate to certify EU importers which should be covered by the registration and the quantities imported into the EU covered by the registration.
(Extended) Safety Data Sheet (eSDS): Every European customer has the legal right to request and receive a REACH-compliant SDS/eSDS in their official language free of charge from its supplier. The supplier has obligation to submit its customer new SDS version within 12 months if any updates are done to the SDS. Generally all European customers accept SDS in English. We provide REACH-compliant SDS service in more than 25 languages with low costs. We can also generate Exposure Scenarios for extended Safety Data Sheet (eSDS) when the substance has been registered and classified.
Study monitor of new study: Study monitor for new physico-chemical test, toxicology and ecotoxicology test.

Our UK company Chemreach UK LTD is located in London and provides UK-REACH services:

UK-REACH registration strategy consulting service
OR (Only Representative) service
DUIN (Downstream User Importer Notification) under UK-REACH Regulation
UK-REACH registration service

Chemreach GmbH provides REACH registration services under Korea REACH (K-REACH) regulation.

Late pre-registration service
Registration service

Chemreach GmbH provides services under Turkey REACH (KKDIK) regulation.

Late Pre-registrion service: the pre-registartion number is valid until 31 December 2023
CLP Notification service
Safety Data Sheet (SDS) service

REACH Registration Costs mainly consist of:

1. Cost of the Letter of Access (LoA): This cost mainly depends on the registered substance, the number of registrants and the registration quantity. The price of LoA varies very much. However the costs of the LoA should be fair, transparent and non-discriminatory according to REACH regulation.

2. ECHA fees: These fees depend on the registration tonnage band and the size of the company. A reduced fee shall be set for SMEs (small and medium-sized Enterprises), but the enterprise must provide necessary proof to prove that it meets the definition of the SME. A wrong or mistake claim shall be seriously fined.

3. Service Fee for Only Representative: This fee depends on the complexity of the case. The Only Representative shall create a technical dossier and submit the dossier to ECHA on behalf of Non-EU manufacturer.

REACH Glossary & Official Definitions

Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

Mixture: means a mixture or solution composed of two or more substances;

Article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition; (Article Compliance: REACH regulation also covers articles. Articles are defined under REACH as objects with a special design or surface that is more important than their chemical composition. If an article contains an intended released substance during their normal use, this substance is subject to REACH registration. If an article contains SVHC substances whose total amount is more than 1 tonne per year and concentration exceeds 0.1%, communication with customers is required and REACH notification to ECHA is necessary. If the substance has already been REACH registered or exposure to humans and the environment can be excluded, notification is exempted. The enforcement authorities donot demand test results. Other methods of proving REACH compliance of an Article are also acceptable, e.g. declarations by reliable suppliers are regarded as an alternative. )

Producer of an article: means any natural or legal person who makes or assembles an article within the Community;

Polymer: means a substance consisting of molecules characterized by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:

(a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;

(b) less than a simple weight majority of molecules of the same molecular weight.

In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer;

Monomer: means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;

Registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance;

Manufacturing: means production or extraction of substances in the natural state;

Manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community;

Import: means the physical introduction into the customs territory of the Community;

Importer: means any natural or legal person established within the Community who is responsible for import;

Placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market;

Downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user;

Distributor: means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties;

Intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis):

(a) non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;

(b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities;

(c) transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;

Site: means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;

Actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain;

Phase-in substance: means a substance which meets at least one of the following criteria:

(a) it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);

(b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this;

(c) it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, by the manufacturer or importer before the entry into force of this Regulation and it was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC in the version of Article 8(1) resulting from the amendment effected by Directive 79/831/EEC, but it does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this, including proof that the substance was placed on the market by any manufacturer or importer between 18 September 1981 and 31 October 1993 inclusive;

Notified substance: means a substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC;

Product and process orientated research and development: means any scientific development related to product development or the further development of a substance, on its own, in mixtures or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance;

Scientific research and development: means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year;

Use: means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilization;

Registrant's own use: means an industrial or professional use by the registrant;

Identified use: means a use of a substance on its own or in a mixture, or a use of a mixture, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user;

Full study report: means a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed;

Robust study summary: means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report;

Study summary: means a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study;

Per year: means per calendar year, unless stated otherwise, for phase-in substances that have been imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years;

Restriction: means any condition for or prohibition of the manufacture, use or placing on the market;

Supplier of a substance or a mixture: means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture;

Supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market;

Recipient of a substance or a mixture: means a downstream user or a distributor being supplied with a substance or a mixture;

Recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers;

SME: means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises;

Exposure scenario: means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate;

Use and exposure category: means an exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as a minimum, in terms of the brief general description of use;

Substances which occur in nature: means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means;

Not chemically modified substance: means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities;

Alloy: means a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means.

Acronyms

ECHA: European Chemicals Agency;

CAS no.: Chemical Abstracts Service registry number;

EC no.: European Community number;

CMR: Carcinogenic, Mutagenic, Toxic for Reproduction;

PBT: Persistent, Bio-accumulative and Toxic;

vPvB: very Persistent and very Bioaccumulative;

SVHC: Substance of Very High Concern;

CSR: Chemical Safety Report;

DU: Downstream User;

EEA: EU countries plus Norway, Iceland and Liechtenstein;

EINECS: European Inventory of Existing Commercial Chemical Substances that is the list of substances on the EC market between 1 January 1971 and 18 September 1981;

ELINCS: European List of Notified Chemical Substances, that is, the list of substances marketed as of 18 September 1981 and notified under Directive 67/548/EEC. The substances listed in ELINCS are regarded as registered;

IUCLID: International Uniform Chemical Information Database;

OSOR: One Substance, One Registration;

PPORD: Product and Process Oriented Research and Development;

(Q)SAR : Qualitative or Quantitative structure-activity relationship; Results obtained from valid (Q)SARs may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when certain conditions are met;

Read-across approach: Information on intrinsic properties of substances may be generated by means other than tests, in particular from information from structurally related substances;

SIEF: Substance Information Exchange Forum.

Useful links:

ECHA (European Chemicals Agency)

https://echa.europa.eu/home

REACH regulation

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02006R1907-20161011&from=EN

Candidate list of SVHCs

https://echa.europa.eu/candidate-list-table

Company size category

https://echa.europa.eu/support/small-and-medium-sized-enterprises-smes/how-to-determine-the-company-size-category/step-5

ECHA Fees regulation

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2015_139_R_0001