REACH

REACH is here

After many years of difficult negotiations and much controversy the new EU Chemicals Strategy, known as REACH (standing for the Registration, Evaluation and Authorisation of Chemicals), is a reality. The text was agreed politically on 18 December and published on 30 December. The full text (all 849 pages of detailed legal, technical and scientific requirements) can be found at:

http://europa.eu.int/eur-lex/lex/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML

REACH, which enters into force on 1 June 2007, places duties on actors throughout the chemical supply chain. Companies and other stakeholders will need to have a detailed understanding of how REACH will affect them and the skills and functions needed to meet these duties. Many decisions are already being taken in supply chains and some deadlines in REACH are close; you need to act now [ see REACH: Priorities for Action ].

PTK is in a position to help you meet the challenge that REACH places on industry [ see REACH: Services Available ]. Andrew Fasey is in a uniquely qualified position to help as one of the (very few) authors of the European Commission’s REACH proposal and as the Special Advisor to the Government of Finland on REACH in their successful aim of finalising the REACH negotiations during their period as Presidency of the European Union in the second half of 2006. Andrew is helping many companies, trade associations, stakeholders and academic institutions plan for REACH and deliver as effectively and efficiently as possible.

PTK work closely with other expert collaborators to ensure that all potential services can be delivered as part of a ‘One Stop Shop’ [ see REACH: Collaborators ]; perhaps the best ‘REACH team’ in the world.

REACH (Registration, Evaluation and Authorisation of Chemicals) is perhaps the most high profile and politically sensitive legislation of many years. It will impact on manufacturers and importers of substances (either on their own or in preparations/mixtures) as well as all downstream users of chemicals. It requires extensive information on properties and uses of substances as well as the measures needed to manage the risks posed to be registered with a central Agency. Such registrations are subject to evaluation by the new European Chemicals Agency (ECHA). It introduces new approaches for the safe management of the most dangerous chemicals through a system of authorisation. The extent of the impact of REACH cannot be over-estimated. This impact could be both positive and/or negative depending on how you react.

Reaction to the legislation has been mixed: some fear that REACH could threaten their existence if key substances are lost to the market (estimates of 1-40% of substance losses have been made), others see it as a great opportunity for competitive advantage in a cut-throat business world, whilst others see the benefits to human health and the environment it will bring. How you react will dictate whether REACH is a force for good or bad for your business. REACH has been designed to increase the levels of protection for human health and the environment whilst increasing innovation. Understanding it and how to apply it is key to making REACH work for you.

PTK can:



Priorities for Action

  1. Pre-registration: pre-registration of phase-in substances is from 1 June 2008 – 30 November 2008 (inclusive). It is important that you do pre-register phase-in substances that you manufacture in, or import into, the EU so that you can take advantage of the phase-in deadlines. Failure to do so will mean immediate registration is required or removal of the substance from the EU market. As a downstream user it is important to ensure that substances supplied to you and important to your business are pre-registered up the supply chain to help ensure continued supply.

  2. Understand your supply chain: REACH will impact on all parts of chemical supply chains (i.e. all sectors of industry will be affected). It is important that you communicate with your suppliers and customers.

  3. Portfolio/Inventory: you should pull together and record all the information you have on supply chains, REACH duties, timing issues, and available data (etc) in one place.

  4. Identify vulnerabilities in your supply chain(s): REACH will cause some substances to be removed from the market and other serious and less serious affects. You should try and identify these and if appropriate identify alternative suppliers, substances or processes.

  5. When to meet your duties arising from REACH and where they will come from.

  6. Tracking: REACH is not a ‘once only exercise’ and there is still a great deal of uncertainty over many of the provisions. You need therefore to track what is happening on REACH (e.g. the development of guidance [ http://ecb.jrc.it/REACH/ ] , whether other duties will fall on you as a result of evaluation, restrictions or authorisation, and whether anything has changed in your company (e.g. higher volume manufactured leading to an update of the Registration dossier) or supply chain meaning that other duties may apply.


The Basic Elements of REACH

REACH will create a single system for both ‘existing’ and ‘new’ chemical substances. Its basic elements are:

  1. Registration requires manufacturers and importers (M/I) of substances (on their own, in preparations, and in some cases in articles) to obtain and submit to a new European Chemicals Agency (ECHA) information on them and to use that data to manage them safely. A single hazard data set is required per registered substance (this requirement is misleadingly often referred to as ‘One Substance One Registration’ (OSOR)). The registration requirement starts at 1 tonne per M/I per year. Data requirements increase at various tonnage thresholds (1t; 10t; 100t; and 1000t per M/I per year) with the timing of registrations staggered. Starting at 1000t, substances classified as R50/53 at 100t, and CMRs (carcinogens, mutagens and reproductive toxicants) at 1t per M/I per year after 3 1/2 years; 100t per M/I per year after 6 years; with the rest (1 – 100t per M/I per year) being required 11 years after REACH enters into force. There are reduced registration requirements for most substances registered at the 1 – 10 t level.

  2. To reduce testing on vertebrate animals, data sharing is required for animal studies.

  3. Better information on hazards and risks and how to manage them will be passed down and up the supply chain.

  4. Downstream users are brought into the system in a systematic way.

  5. The aim of Evaluation is to prevent unnecessary testing, by having the ECHA evaluate the proposals for testing made by registrants, and to check compliance of a minimum of 5% of registrations with the registration requirements. Evaluation also enables authorities to investigate substances with potential risks by asking industry for further information. This information may be used later to prepare proposals under Restrictions or Authorisation.

  6. Substances with properties of very high concern (SVHC i.e. CMRs, PBTs (persistent, bioaccumulative and toxic), vPvBs (very persistent and very bioaccumulative) and other substances with a similar level of danger (e.g. endocrine disruptors)) will potentially be subject to the authorisation process. Applicants for the authorisation of uses of SVHC will have to demonstrate that risks associated with the use of such substances are adequately controlled. In this case the Commission will grant an authorisation for that substance and use. Otherwise an authorisation may be granted for uses of these substances if the socio-economic benefits outweigh the risks and there are no suitable alternative substitute substances or technologies. All applications for authorisation will need to include an analysis of alternatives.

  7. The Restrictions process provides a procedure to place conditions (including bans) on the manufacture, placing on the market or use of certain dangerous substances. The restrictions process acts as a safety net to manage Community-wide risks that are otherwise not adequately controlled.

  8. A European Chemicals Agency (ECHA) will manage the technical, scientific and administrative aspects of the REACH system at Community level, aiming to ensure that REACH functions efficiently and has credibility with all stakeholders.

  9. A classification and labelling inventory will help promote harmonisation of classifications of a substance. For CMR substances as well as respiratory sensitisers there may be a Community-wide agreement on the classification by the authorities (analogous to the current Annex 1 to Directive 67/548/EEC).

  10. Access to information rules combine a system of publicly available information over the internet, the current approach to requests for access to information, and specific rules on the protection of confidential business information (CBI).

This is a highly simplified representation of a long and detailed legal instrument. Please seek expert advice before making any decisions on how REACH applies to you.



REACH Services Offered by PTK Ltd and Collaborating Organisations

Skills/Functions/Resources:

Duties:

Customers:

The above is a non-exhaustive list. Please contact PTK if there are other services you require.



Registration Deadlines