Substance Evaluation - ECHA (2024)

FAQs

What is the ECHA substance evaluation process? ›

The substance evaluation process assesses all registration dossiers from all registrants specific to the same substance or group of substances, i.e. in order to take into account the aggregated tonnages of production and combined exposure. Other available sources of information are also considered.

To ensure that ECHA undertakes a compliance check on the most up to date information in the registration dossier, ECHA requests Registrants to pro-actively review their related registration dossiers and update them with any new and/or relevant information such as new hazard information, changes in uses and exposure, ...

Restrictions are normally used to limit or ban the manufacture, placing on the market (including imports) or use of a substance, but can impose any relevant condition, such as requiring technical measures or specific labels.

A Substance Use Evaluation, also known as a drug and alcohol evaluation, is a process that takes place between an individual and an addictions counselor. The goal of the process is to assess whether or not an individual's alcohol and/or drug use is a problem.

You need to submit sufficient information in your dossier to allow ECHA to independently assess each endpoint. ECHA can examine the full dossier, or target the examination to certain parts of the dossier or certain endpoints.

A substance is defined as a phase-in substance if it meets at least one of the following criteria: It is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS). [Substances with EC number starting with 2 or 3 are listed on EINECS.]

Compliance checks are short, focused reviews, typically providing a high-level investigation of the extent to which statistics meet the standards of the Code of Practice for Statistics – Trustworthiness, Quality and Value.

What Is A Compliance Checklist? A compliance audit checklist is a compliance tool utilized by external or internal auditors to assess and verify an organization's adherence to government regulations, industry standards, or the company's own policies.

A substance of very high concern (SVHC) is a chemical substance (or part of a group of chemical substances) which has been proposed as a candidate for inclusion on the Authorization or Restriction list (see: ECHA Lists) of REACH.

What are the 10 substances in RoHS? ›

The RoHS Directive currently restricts the use of ten substances: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).

The RSS applies to all NEXT suppliers, manufacturers, agents and sourcing operations engaged in supplying NEXT and must be adhered to without exception at all times. The RSS standards lay out the maximum limits for the chemicals or substances allowed in finished products.

A thorough substance use assessment includes a detailed inventory of the type, amount, frequency, and consequences of the patient's substance use, their perception of their use, and readiness to change. Additionally, we review past medical and psychiatric history and assess for co-occurring psychiatric disorders.

Evaluation of a drug ensure the identity of a drug and determines the quality and purity of drugs. The main reasons behind the need for evaluation of crude drugs are biochemical variation in the drug, effect of treatment and storage of drugs, and the adulterations and substitutions.

Evaluation can be achieved in four successive steps, taking into account both therapeutical and financial aspects. The first two steps, determining efficacy and applicability, represent the current system of evaluating drugs before allowance to the market.

The Drug Use Disorders Identification Test (DUDIT) and Drug Abuse Screening Test (DAST) are used to assess drug use. The Screening, Brief Intervention, and Referral to Treatment (SBIRT), widely used in the US also incorporates a referral to treatment path for clients identified with problematic substance use (15).

The SVHC identification is based on the hazard properties of a substance. Comments are particularly welcome on: the identity of the substance (i.e. on the substance name/EC number/CAS number/molecular structure etc.) PBT or vPvB properties and on properties giving rise to an equivalent level of concern.

The goal of substance abuse screening is to identify individuals who have or are at risk for developing alcohol- or drug-related problems, and within that group, identify patients who need further assessment to diagnose their substance use disorders and develop plans to treat them (see Chapter 4).

Evaluation under REACH focuses on three different areas: Examination of testing proposals submitted by registrants. Compliance check of the dossiers submitted by registrants. Substance evaluation.