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KNOWLEDGE BASE

REACH

REACH REGULATION

Legal:

REACH is the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007. It streamlines and improves the former legislative framework on chemicals of the European Union (EU).

The main aims of REACH are to ensure a high level of protection of human health and the environment from the risks that can be posed by chemicals, the promotion of alternative test methods, the free circulation of substances on the internal market and enhancing competitiveness and innovation.

When REACH is fully in force, it will require all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year to register these substances with a new European Chemicals Agency (ECHA) in Helsinki, Finland. Since REACH applies to some substances that are contained in objects (articles in REACH terminology), any company importing goods into Europe could be affected.[4]

The European Chemicals Agency has set three major deadlines for registration of chemicals. In general these are determined by tonnage manufactured or imported, with 1000 tonnes/a. being required to be registered by 1 December 2010, 100 tonnes/a. by 1 June 2013 and 1 tonne/a. by 1 June 2018. In addition, chemicals of higher concern or toxicity also have to meet the 2010 deadline.

The CLP regulation sets the rules for classification and labelling of chemicals. It aims to determine whether a substance or mixture displays properties that lead to a classification as hazardous.

CLP itself does not set information requirements (except for determining physical properties). The information requirements laid down in REACH will however, ensure availability of much data.

Once such properties are identified and the substance or mixture is classified accordingly, manufacturers, importers, downstream users and distributors of substances or mixtures, as well as producers and importers of certain specific articles (explosive articles which are subject to classification according to Part 2 of Annex I to CLP) should communicate the identified hazards of these substances or mixtures to other actors in the supply chain, including to consumers.

The hazard of a substance or mixture is the potential for that substance or mixture to cause harm. It depends on the intrinsic properties of the substance or mixture. In this connection hazard evaluation is the process by which information about the intrinsic properties of a substance or mixture is assessed to determine their potential to cause harm. In cases where the nature and severity of an identified hazard meets the classification criteria, hazard classification is the assignment of a standardised description of this hazard of a substance or a mixture causing harm to human health or the environment.

Hazard labelling allows for the communication of hazard classification to the user of a substance or mixture, to alert the user to the presence of a hazard and the need to avoid exposures and the resulting risks.

CLP sets general packaging standards, in order to ensure the safe supply of hazardous substances and mixtures.

For further reading: An introduction to the CLP for professional suppliers/users

What are the main features of the Regulation on classification, labelling and packaging – CLP?

The aim of the Regulation is to enable a judgment on a substance or mixture (preparation) with respect to its hazardous properties and to provide a hazardous chemical with pertinent hazard labelling and information on safety measures.

ANNEX II - MATERIAL SAFETY DATA SHEET

The Annex II of EU Regulation (EC) No 1907/2006 (REACH) has mandated what information should and could be included in each section of the SDS. This annex II is ammended by the COMMISSION REGULATION (EU) No 453/2010 in May 2010. All SDS shall meet the latest requirements of REACH regulation.

The Commission has adopted a Regulation amending the REACH Annexes relevant for SDS – Annex II and, to a lesser extent, Annex VI.  The revision brings the SDS requirements into line with the Regulation on Classification, Labelling and Packaging (Regulation (EC) No 1272/2008) and with the guidance on the preparation of SDSs as laid down in the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) of the United Nations.  A three column reference document  compares Annex II as amended from 1 December 2010 onwards, with the relevant text of the GHS and with the original version of Annex II.

ANNEX XIV - REACH Substances of Very High Concern (SVHC)

SVHC (ang. substances of very high concern – SVHC)

In general terms an SVHC is a substance meeting one or more of the following criteria:

  • Class 1 or 2 carcinogen, mutagen, or toxic for reproduction (CMR)
  • Substance which is PBT (persistent, bio-accumulative and toxic) or vPvB (very persistent and very bio-accumulative) in accordance with Annex III of REACH
  • Other substances for which there is evidence of equivalent degree of concern (e.g. endocrine disruptors)

Some substances from the candidate list will be prioritized for authorization and be included in Annex XIV (“SVHC authorization list“). Those substances on authorization list will not be allowed to be used, placed on the market or imported into the EU after a date to be set unless the company is granted an Authorization.

There are 151 substances on SVHC candidate list and 22 substance on SVHC authorization list(updated in April 2013). The history of the update of SVHC candidate list is shown in the following table.

ANNEX XVII The list of restrictions
The list of restrictions contains those substances (on its own, in a mixture or in an article) for which manufacture, placing on the market or use is limited or banned in the European Union.
This list is Annex XVII to REACH and includes all the restrictions adopted in the framework of REACH and the previous legislation, Directive 76/769/EEC. Each entry shows the substance or group of substances or the mixture, and the conditions of their restriction.
The latest consolidated version of REACH presents the restrictions adopted until that date. Subsequent changes are included in the amending Commission regulations.

CLP

CLP/GHS

CLP is the Regulation on classification, labelling and packaging of substances and mixtures. This Regulation aligns previous EU legislation on classification, labelling and packaging of chemicals to the GHS (Globally Harmonised System of Classification and Labelling of Chemicals). Its main objectives are to facilitate international trade in chemicals and to maintain the existing level of protection of human health and environment. The GHS is a United Nations system to identify hazardous chemicals and to inform users about these hazards through standard symbols and phrases on the packaging labels and through safety data sheets (SDS).

The CLP Regulation was published in the Official Journal 31 December 2008 and entered into force on 20 January 2009. According to the Regulation, the deadline for substance classification according to the new rules will be 1 December 2010. For mixtures, the deadline will be 1 June 2015. The CLP Regulation will ultimately replace the current rules on classification, labelling and packaging of substances (Directive 67/548/EEC and preparations (Directive 1999/45/EC after this transitional period.
Further information on this Directive can be found on the following website of DG Environment.

The classification and labelling of your mixtures is changing! 
New pictograms with a white background are replacing the orange ones in the EU. From 1 June 2015 companies are required to classify and label both substances and mixtures according to the CLP Regulation.   Make sure you learn what the labels mean and read the instructions to ensure safe use.

Rozporządzenie 1272/2008

Rozporządzenie (WE) nr 1272/2008 z dnia 16.12.2008 r. w sprawie klasyfikacji, oznakowania i pakowania substancji i mieszanin, zmieniające i uchylające dyrektywy 67/548/EWG i 1999/45/WE oraz zmieniające rozporządzenie (WE) nr 1907/2006.

KLASYFIKACJA

Każda substancja lub mieszanina chemiczna podlega klasyfikacji pod względem wszystkich stwarzanych przez nią zagrożeń – fizycznych, dla zdrowia człowieka lub dla środowiska, z określeniem kategorii zagrożenia

Od 1 grudnia 2010 r. do 1 czerwca 2015 r. obowiązuje podwójny system klasyfikacji substancji i mieszanin.

  • Istniejący obecnie system DSD – DPD
  • Nowy system CLP

Zmiany

Zastosowanie nowych kryteriów klasyfikacji może spowodować, że klasyfikacja może się różnić od dotychczasowej. Zgodnie z art. 55 rozporządzenia nr 1272/2008 z dniem 20 stycznia 2009 r. został uchylony załącznik I do dyrektywy nr 67/548 (wykaz substancji niebezpiecznych wraz z ich klasyfikacją i oznakowaniem). Od tej daty obowiązuje natomiast tabela 3.2 załącznika VI do rozporządzenia nr 1272/2008.

Pictograms
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