Deadline for notification of substances in articles

Beginning with 2011, companies have to notify substances manufactured in or imported into the EU, either as such or in a preparation, to the Classification & Labelling Inventory.

June 1, 2011, another notification obligation for manufacturers and importers of articles becomes effective. Producers and importers have to notify substances of very high concern (SVHC) in articles.

Who has to notify and what is the information to be submitted?

The criteria for the notification are:

• the article contains a SVHC substance >0,1 % mass.
• the total tonnage per year and producer / importer
  of the svhc substance is > 1t
• the producer or importer cannot exclude exposure
  to humans or the environment during normal or reasonably
  foreseeable conditions of use (including disposal)
• the substance has not been registered for that use

Which information has to be submitted?

Besides the identity and contact details of the producer or importer, the registration number (if available) and various information about the substance identity and classification have to be provided. In addition, also information about uses and tonnage bands has to be submitted to the agency.

Producers and importers of articles, who do not deal with substances in their daily business, will discover difficulties by gathering and providing this specific information.

Find out if your article is affected and start gathering information in time. After the extension of the candidate list, companies will have a six months period for the notification of SVHCs in their articles.

New ECHA Guidance Document

April 1, 2011, the European Chemicals Agency has released the second version of the “guidance on requirements for substances in articles”.

Companies manufacturing, importing or dealing with articles should follow the interpretations of this guidance document. Although they are not legally binding, the guidance documents are used by national authorities and serve as consultation sources in court proceedings.

An important change within the guidance document may, in a worst case, lead to new obligations for those producers or importers of products that are not longer seen as articles but as substances.

Suddenly, those companies may find themselves under the obligation to register. In such a case it might well be that they have not done a pre-registration or have even missed a deadline already.

Check now, whether your product is, in the light of the new guidance document, rather viewed as an article or as a substance or preparation, and re-assess your obligations under REACH.

Helpless Downstream Users?

The REACH-EN-FORCE II project starting summer 2011 will focus on the obligations of downstream users in REACH, and inspectors have attended special trainings.

But what are the exact obligations a downstream user has to fulfill and what are the timelines?

Many of them are not sure about their duties but also about their rights. Some companies have not informed their suppliers about their identified uses of substances that may have been registered meanwhile. They are now running the risk of not having their uses considered in the exposure scenarios of the Chemical Safety Reports and the Extended Safety Data Sheets.

These companies now need a solution or a proof for compliance with the requirements of art. 37 REACH.

Safety Data Sheets also will be a topic inspectors focus on. As industry had experienced difficulties with the implementation of the new format in time, CEFIC asked ECHA for more patience and a grace period. Nevertheless, the enforcement is carried out by national authorities who may strictly stick to the statutory provisions and timelines.

REACH affects all kind of businesses!

Do you know if your company is concerned by REACH? Many companies that are not primarily affected by the regulation because they do not produce or deal with substances or preparations nevertheless do have obligations under the REACH and CLP regulations. Companies using substances or preparations, so called Downstream Users, or dealing with articles also have to fulfill obligations in order to be compliant with REACH.

RoHS = Mini-REACH?

The RoHS Recast is just about to be finally approved. During the legislative process, industry had favored the alternative to include this substance-related directive within the REACH regulation. The Europeean legislation did not move into this direction.
The draft directive now rather looks like a Mini-REACH. Why?
Looking at the new rules of the RoHS recast and at the alternatively available arrangements of the authorization and restriction processes of REACH, the result is the following comparison:

Same or similar rules in RoHS recast and REACH

1. Personal Scope:  Manufacturers and importers
2. Objective Scope: The Reach Regulation with respect to articles also
    includes all electrical and electronic products
3. Ban of substances: is controlled by authorization or
    restriction under REACH
4. Exemptions (products and restriction of substances):
    can be integrated in the REACH regulation.
5. Criteria for decision for exemptions, new banned substances,
    authorization and restrictions: by far  the same

Different rules in RoHS recast and REACH

1. The RoHS directive has a protective purpose:
    Recycling worker’s health and environmental aspects of handling
    and recycling
2. The ban of substance of the RoHS directive leads to a general,
    product-related ban of sales, even for products from outside the EU.
    REACH regulates only information duties within
    the supply chain (art. 33). Restrictions can also define that products
    containing certain hazardous substances are not allowed
    to be placed on the market.
    For these items only, separate rules would have been necessary
    to be included in the from the RoHS directive.

Do these differences justify a separate directive like RoHS additionally to the REACH regulation?  Rather not! A reduction of the amount of legislation and a harmonization of procedures without changes in the objectives and in the interest of the industries concerned would have been possible.  Too bad…

K&L at REACH- and CLP-Workshop in Berlin

K&L is a regular participant at the REACH workshops conducted by BDI (Bundesverband der Deutschen Industrie) in Berlin. The recent event took place February 23. Topics on the agenda centered round industry’s difficulties in implementing the REACH regulation.

The participants discussed legal consequences of ECHA’s changed guidelines. Currently, the guideline on how to handle substances in articles is undergoing a review and will result in new or modified obligations for industry. Manufacturers with so far no registration duty will be abruptly confronted with the obligation to register.

The obligations for companies to notify substances in articles according to art. 7 (3) will discover difficulties in gathering all information required. For importers of an article with notification obligation of svhc (substance of very high concern) it will be hardly possible to have information available about e.g. optical activity or purity of the substance.

K&L attends such workshops in order to gather detailed information about the industry’s requirements and opinion of the REACH and CLP regulation. We are close to our customers and their needs and customize our consulting services accordingly. For the upcoming workshops, K&L will participate with a presentation, sharing our knowledge and experience.

Annex XIV filled with 6 SVHCs

The following 6 substances of very high concern (svhc) have been put into Annex XIV of the REACH regulation yesterday, and for further sales or use are from now on subject to authorization.

•      5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
•      4,4`-diaminodiphenylmethane – MDA
•      hexabromocyclododecane – HBCDD
•      bis(2-ethylhexyl)phthalate – DEHP
•      benzylbutylphthalate – BBP
•      dibutylphthalate – DBP

After the so called “Sunset Date” as a grace period in 2014 and 2015, those substances are not allowed to be placed on the marked or used unless companies have successfully passed the authorization process.
For an authorization, companies have to prove taking security measures that are necessary for an appropriate control of risks, or state that the benefit for the economy and the society prevails.
If there are existing substitutes or technical procedures as a feasible alternative, schedules for the conversion have to be presented.
Substances that are put on Annex XIV remain part of the candidate list and subject to the information requirements for substances in articles.

K&L offers REACH service packages for SMEs

Within the REACH schedule, many SMEs are expected for the 2013 registration period. For those companies, K&L offers a special registration service package.
In general, SMEs do not necessarily have the expertise, capacity, required data and studies for an individual registration. In order to effectively fulfill their registration obligations, they need a quick, secure and cost-saving registration path by e.g. joining a Lead registration.
The K&L Joint registration package for SMEs comprises

– an introductory presentation on REACH and
– the evaluation of obligations in a first meeting
– communication with the Lead registrant and the authorities
– generation of the Technical Dossier
– generation of the Chemical safety Report
– final submission of the registration

Additional services, if required and necessary are offered in line with the services. Further service packages e.g. for substances in articles are available, too.
This service is suitable for companies with no or a few data and studies that need to register as a joint registrant and are looking for a quick and cost-effective solution for their registration obligations.

REACH-inspection will focus on Downstream Users!

For the coming inspection activities, national inspectors will be especially trained on supervising the REACH and CLP obligations for Downstream Users.

As the role of the downstream users is essential in providing information about hazardous substances and a safe use, it is necessary to raise awareness about their duties for REACH and CLP.

Inspectors e.g. will check if
– Downstream Users comply with their obligation to inform users about
  substances in preparations
– they have checked that the substances they buy have been
  registered or not and
– they have followed their CLP notification duties.

As those inspections will start in summer 2011, we recommend double-checking and analyzing your obligations as a Downstream User in order to fully comply with REACH and CLP.

Revised RoHS directive expected for April 2011

After being adopted by the European Parliament in November 2010, the RoHS (Restriction of Hazardous Substances) recast is currently undergoing a thorough revision process by legal linguists. The formal council adaptation is expected in the course of March and, finally, the publication in the Official Journal should take place in April 2011.

The RoHS recast involves several changes for manufactures, importers and distributers.
Changes and facts in a nutshell:

•    Open product scope with various lists of exemptions
•    Grace period for equipment not falling under RoHS previously
•    Improved exemption process copying the REACH authorization
      process
•    Proceeding for including additional substances to be banned
•    Prove of RoHS compliance with CE mark
•    Labeling of products with name and address of the manufacturer
•    Appointment of an authorized representative
•    Extended local language product documentation required
•    Obligatory self denunciation of non-compliant products and
      components
•    Immediate corrective measures including withdrawal and recall

For industry, importers and traders, the RoHS recast results in new obligations for management of hazardous substances information within the supply chain and new documentation duties.

The implementation into national law will have to be realized until 2012 by the member states. Enforcement will be regulated by member states according to the regulation 765/2008 which became effective January 2010.