REACH

Following the end of the pre-registration period back in December 2008 (the first major REACH Milestone), and now the conclusion of the second major REACH milestone—the registration deadline for the tier one, high volume and high risk substances in 1 December 2010—companies doing business in Europe face additional challenges and hurdles under REACH. Indeed, REACH continues to have far reaching effects not only on the European chemical industry, but also on non-European companies that ship products into the European Union (EU). Not only are manufacturers, importers and users of industrial chemical products impacted, but also companies that produce non-industrial chemical products, such as food packaging materials, cosmetic ingredients, and pesticide and biocide inerts. The 2.7 million pre-registrations and some 20,000 tier one registrations emphasize the fact that REACH poses major challenges for companies trying to manage their EU regulatory obligations strategically and efficiently.

Companies must now face the daunting prospect of dealing with registration of tier two pre-registration, phase-in substances (100-1000 tonnes). The number of registrations and the work involved in submission of tier two registrations is likely to far exceed those relating to tier one. More significantly, the timeframe for submitting these registration dossiers is significantly shorter. Whereas tier one registrants had three and half years to submit their registration dossiers after REACH entered into force, tier two registrants will only have two and a half years before the 1 June 2013 deadline. Realistically, to meet the tier two registration deadlines, testing will have to be complete by end of 2011, at the latest. On top of this, registrants will have to contend with the follow-up issues regarding their 2010 registration dossier, such as responding to testing proposals, rejections of confidentiality justification statements, and REACH dossier evaluation issues.

REACH registration issues apart, there are a significant number of other REACH/CLP compliance issues with potentially much more serious consequences than failure to register. The number of substances being added to the REACH Candidate List—the ‘death row' of dangerous substances—is increasing. Given the significant commercial impact of inclusion on the Candidate List as a Substance of Very High Concern (SVHC), the commercial viability of using particular SVHC substances in industry is likely to be tested and, along with it, the survival of manufacturers and distributors of those substances in the EU. More serious still are the legal consequences of inclusion of a substance on Annex XIV (Authorisation) which, again, are likely to pose life-or-death questions as regards the commercial use of particular substances. Added to this are the financial challenges that the industry will face as regards to REACH restrictions imposed on the use of particular substances.

The ability of companies to anticipate, plan for and react to challenges posed by the next phase of REACH regulations is very likely to determine commercial success or failure. For those reasons, companies should not put REACH/CLP compliance on the back burner, but instead seek to address the challenges regarding REACH/CLP compliance head-on. Keller and Heckman LLP can help you every step of the way!

Keller and Heckman LLP REACH Group

The Keller and Heckman REACH Group is a recognised leader in its field. The Keller and Heckman REACH Group enjoys an enviable reputation among clients and competitors alike across the globe. Our Scientist and lawyers were involved in the development and adoption of REACH right from the 2001 Commission White Paper on the Strategy for a Future Community Policy for Chemicals. Since then we have been involved in resolving some of the most fundamental and complex issues for the chemical, petro-chemical, cosmetic, soap and detergents, bio-fuel, food, food packaging, and other industries. Include:

Successfully lobbying for amendments to be made to Annexes IV (Substances exempted from registration) and V (Categories of substances exempted from registration) resulting in the substantial widening of Annex V (9) provisions.
Challenging TGD Guidance regarding only representatives and ensuring that indirect as well as direct imports of non-EU manufactured substances were covered by only representative registrations.
Challenging ECHA views regarding ‘super-importer' status of only representatives and resolving issues regarding requirement that ORs submit one registration as per each non-EU entity represented.
Influencing amendments made to the TGD on substances in Articles (Appendix 3) as regards requirement to register substances in semi-finished products.
Facilitating ECHA in resolving issues regarding the status of food intermediates under REACH.

REACH Requirements

Registration of most chemicals, both new and old, that are manufactured or imported into the EU in quantities exceeding 1 metric ton per year. The registration obligation falls on manufacturers and importers, but downstream users will also need to ensure that their specific uses are registered. The amount of information and data needed for registration will depend on the tonnage of the chemicals with more data needed at higher tonnage levels. Built into REACH system are provisions for avoiding unnecessary animal testing and for data sharing among registrants. Where new animal testing is needed to support registration, the registrant must first submit a testing proposal to the regulatory authorities. REACH also requires the preparation of a Chemical Safety Report (CSR), essentially a risk assessment and risk management report that describes the chemical, its uses, the hazard and exposure potential, and recommends practices for reducing risk and exposure.

Evaluation of registration dossiers and animal testing proposals by the regulatory authorities, as well as special provisions to allow the call-in of additional data on chemicals of highest concern to the EU regulators.

Authorisation of substances of very high concern, defined as carcinogens, reproductive toxicants, mutagens, persistent and bioaccumulative toxicants, and substances that pose similar problems. The Authorisation is user and product specific and depends in part on the availability of lower risk substitutes.

Restrictions of high risk chemicals or uses where the risks can not adequately be managed and community-wide regulation is needed.
REACH established the European.

Other requirements: REACH changes the requirements governing Safety Data Sheets and requires companies communicate information both up and down the supply chain.

CLP requirements

Notification: Substances which are either (i) subject to the REACH registration requirements; (ii) classified as hazardous and placed on the market; or (iii) contained in preparations above the relevant concentration limits which cause a preparation to be classified as hazardous – must be notified to the ECHA. Notification means providing the ECHA with information on the classification and labelling of a substance.

Classification and labelling: Substances and preparations must be classified, packaged and labelled in accordance with the CLP according to certain deadlines.

Significant deadlines and/or ongoing REACH/CLP obligations

Deadline	Issue	Description
1 December 2010	Registration of tier one pre-registered substances	Article 23(1) REACH
1 December 2010	Classification of substances	Substances must be classified in accordance with the DSD and CLP until 1 June 2015 (derogations apply) (Article 60 CLP).
1 December 2010	Labelling and packaging of substances	Substances must be labelled and packaged in accordance with the CLP (derogations apply) (Article 60 CLP).
1 December 2010/ 3 January 2011	Notification of C&L data (old substances)	C&L data regarding relevant old substances must be notified to ECHA (Article 40(3) CLP)
1 December 2010/ 3 January 2011	Notification of C&L data (new substances)	After 1 December 2010, the C&L data re new substances places on the market must be notified to ECHA within one month (Article 40(3) CLP).
1 June 2011	Notification of SVHCs in articles	Producers/importers of articles must notify ECHA within six months of being included on Candidate List if: a substance is identified as SVHC and (i) in quantities over 1 MT pa and (ii) above 0.1% w/w (Article 7(2) REACH).
1 June 2013	Registration of tier two pre-registered substances	Article 23(2) REACH
1 June 2015	Classification, labelling and packaging of preparations	Substances and preparations must be classified, labeled and packaged in accordance with the CLP (Article 60 CLP).
1 June 2018	Registration of tier three pre-registered substances	Article 23(3) REACH
Ongoing	DUs report information on uses to ECHA	DUs must report information to ECHA within 6 months of receiving a SDS including, within it, a registration number if (i) it must prepare a CSR; or (ii) it relies on less than 1 tonne exemption or PPORD exemption re CSRs (Article 38 REACH).
Ongoing	Duty to inquire re registration for non pre-registered substances	Article 26 REACH
Ongoing	Notify ECHA of PPORD info	Article 9 REACH
Ongoing	Communication in supply chain	Down supply chain: SDS (Article 31 REACH or Article 32 REACH). Up supply chain: new information on hazards/risks (Article 34 REACH).
Ongoing	Info re SVHCs in articles to recipients of articles / consumers	Article 33 REACH
Ongoing	Workers'access to info.	Article 35 REACH
Ongoing	Retain REACH compliance info.	Article 36 REACH
Ongoing	Authorisation

Keller and Heckman LLP REACH Services

Keller and Heckman provides a range of services designed to assist companies in preparing for REACH and in complying with REACH obligations after the legislation takes effect. These services include:

Legal and Scientific Support for Strategic Decision-Making

Assistance in auditing product portfolios
Determination of exemptions from REACH Registration
Assessment of the regulatory status of substances, preparations and articles
Determination of available data and assessment of possible cost of registration
Setting up of scientific and legal strategies limiting the risk of authorisation and/or paving the way to easier granting of authorisation through the preparation of appropriate registration dossiers and communication with customers

Legal and Scientific Support on Registration

Representation in the Substance Information Exchange Forum (SIEF) and consortia
Registration and pre-registration for non-EU manufacturers as "only representative" in special cases
Consortium set up/management
Technical consulting to consortia and companies
Third party for handling of CBI-sensitive information
Dossier compilation
Preparation of robust study summaries
Preparation of CSRs and SDSs
Exposure assessment/modeling/scenarios
Chemical characterization
Preparation of cost-effective testing strategies and testing proposals
Placing and monitoring of studies (all endpoints)
Preparation of waivers for specific endpoints
Follow-up of evaluation with the Rapporteur Member State and the Agency

Legal and Scientific Support on Authorisation

PBT/vPvB evaluation and/or rebuttals
Rebut substances of equivalent level of concern
Representation and advocacy concerning Candidate List inclusion and SVHC designations
Authorisation request compilation
Identification of possible substitutes
Scientific and socio-economic analysis of substitutes
Follow-up authorisation request with the Agency
Rebut proposed restrictions

Litigation

Appeals against decision of the Agency (e.g., data disclosure)
Legal actions against adverse, arbitrary or disproportionate procedures and decisions