The new legislation on chemical safety: The Reach Regulation and CLP and their implications in the Small and Medium Enterprise

The acronym REACH stands for:
• Registration
• Evaluation
• Authorization
• Chemicals

While the acronym CLP stands for:
• Classification
• Labeling
• Packaging

The REACH regulation stems from the famous White Paper issued in 2001 concerning the future of chemicals’ policy by the EU; since the time of the White Paper until the entry into the regulation there has been much debate on many critical issues.

The CLP regulation stems from the GHS, which is a global system of harmonization of the classification and labeling of chemicals on a voluntary basis, wanted by the UN; the main goal of CLP is to standardize the criteria for classification and labeling of substances.

This originates from the fact that often the same substance is classified and labeled differently from country to country. For example, a substance with some oral toxicity is classified in Europe as harmful, in the U.S. as toxic, whereas in China is classified as dangerous. With the GHS system, and thus with CLP, the substance is listed as dangerous Category III, and is represented by a symbol containing the skull and crossbones.

Critical issues raised in reference to the application of REACH and CLP in Small and Medium Enterprises
The main critical points of the implementation of the REACH Regulation and CLP is mainly concerned with its economic / managerial impact, and with the increased costs of chemicals, as well as with the serious risk of disappearance of some chemicals, and probable loss of competitiveness by the European industry

Regarding the management of chemicals before REACH, provisions were made for a distinction between existing substances (chemicals on the market on September 1981 EINECS inventory), and new substances (chemicals put on the market after 1981 ELINCS inventory).

Basic principles of REACH framework.
The REACH Regulation is based on the following principles:
• precautionary principle
• burden of proof by the operator / company
• due diligence (all companies must be socially responsible, not only those receiving specific obligations)
• collection and dissemination of information through supply chains

The implementation of REACH, involves both, the chemical substances and some subjects / dealers, namely:

• manufacturers and importers of substances as such
• manufacturers and importers of preparations
• manufacturers and importers of articles containing substances intended to be released
• manufacturers and importers of articles containing "extremely worrisome substances"
• "downstream users" of substances, preparations and articles

The relationship between the various dealers and the REACH regulation is developed through the so-called "Registration" of the subject substance in the procedures for implementing REACH.

For existing substances the pre-registration phase has already taken place, because such substances are subject to the transitional phase-in substances regimen (existing substances on the market on Sept. 1981; EINECS inventory: European Inventory of Existing Chemical Substances), with the benefit of further registration deadline; vice-versa, for new substances the registration process began June 1, 2008.

Certain substances are exempted from Registration, include polymers, and substances regulated by other laws, such as substances used for plant protection, substances used for bio acid products, substances used in medicines, and substances used in foods, all with the necessary rules and exceptions.

The registration of substances includes the requirement to submit to the European Chemical Agency (ECHA) a series of basic information about the properties of the substances, and, in the absence of available data, the registrant has the obligation to perform experimental tests to characterize their physicochemical, toxicological and environmental properties.

The documents for recording, are collected in a technical booklet containing information on:

• Identity of the substance and its manufacture
• Use identified by the registrant
• Classification and labeling of the substance
• Instructions on safe use
• Summary of physicochemical, toxicological and ecotoxicological data, depending on the quantities

The Chemical Safety Report (CSR-Chemical Safety Report) is mandatory for substances produced or imported in quantities ≥ 10 tons per year; such report shall contain the following elements:
a) evaluation of hazards to human health
b) physicochemical hazard assessment
c) assessment of environmental hazards
d) persistent, bioaccumulative toxicity (PBT), and very persistent and very bioaccumulative toxicity (vPvB)

If the substance turns out to be dangerous the report must also include:

e) exposure assessment, description of the scenario(s) of exposure relative to the manufacturing, or to the use(s), or identified for all phases of its life, including the disposal.
f) characterization of risks, followed by risk management measures, and an indication of operating conditions that the manufacturer, or importer, has implemented or recommends to the downstream users, so that risk is adequately controlled

For substances contained in articles, the registration includes those substances that may be released for normal and predictable uses, such as aromatic substances contained in articles.

SUBSTANCES CONTAINED IN ARTICLES:
For items not intended to release substances, such as clothing, plastic items, etc. the compliance is addressed only to substances of very high concern, the so-called SVHC, substances such as carcinogenic, mutagenic and toxic to reproduction, persistent and bioaccumulative substances, and substances that act as endocrine disrupters.

The supplier of an article is obliged to notify the recipient of the article of the presence of a SVHC substance if in concentrations higher than 0.1%.

Summary of the general principles of the CLP Regulation
The CLP regulation primarily implements the GHS in order to establish a common and consistent basis for chemical hazards, and establishes criteria for hazard identification, using the classification, as well as reporting danger, with the harmonization of the labeling, and MSDS.
The application of new criteria for classification, labeling and packaging will be mandatory from December 1, 2010 for substances, and for mixtures from June 1, 2015.

Given that the CLP Regulation will replace the directives on dangerous substances and preparations, it will certainly have an impact on regulations that refer to the classification criteria for substances and mixtures, such as, for example, the waste legislation and the legislation relating to the health and safety at the workplace.