Of particular interest in this EETimes.com report is how REACH is still poorly understood by many companies:

A survey has thrown up major concerns that the recently adopted EU REACH (Registration, Evaluation and Authorization of Chemicals ) regulation will disrupt metal and chemical supply to the EU and this could start to cause major disruptions by the end of this year if importers do not begin to take action to deal with the regulation.

The worrying results of the survey, conducted by IPC Market Research, suggest that the majority of solder suppliers have very limited knowledge of the regulations. When asked about awareness and readiness for REACH compliance, most scored a 1 (none) in response to a 10 point scale.

This is a worrying and surprising statistic with less than 3 months for pre-registration under REACH, according to IPC.

Companies may not understand that the implications of not being REACH compliant could lead to exclusion from the EU market, thus resulting in inevitable interruptions in trade.

REACH is expected to impact every company within the EU, especially those depending on non-EU suppliers.

Click on the above link for the full story.

A REACH update from Electronics Design, Strategy, News:

The EU (European Union) environmental NGOs (non-governmental organizations) through the International Chemical Secretariat has released its “Substitute It Now” (or aptly acronymed “SIN”) list of 220 chemical substances considered to be possible Substances of Very High Concern under REACH (Registration, Evaluation, and Authorization of Chemicals).

As a reminder, REACH began on June 1, 2007, and aims to streamline and improve the former legislative framework for chemicals in the EU. Under REACH, manufacturers and importers must register substances they produce or import in quantities of one ton or more per year per company by end of 2008. These companies may not use any substance that REACH determines to be a Substance of Very High Concern in products unless granted authorization.

Electronics supply chain watchers at Design Chain Associates reported that the SIN list was introduced at a conference held Wednesday in Brussels. The European Chemicals Agency had published a proposed list of 16 substances earlier this month. Design Chain Associates had its director of EU law and policy, Kris Pollet, at the Brussels meeting and reported that the European Chemicals Agency expects the first candidate list to be approved on October 22.

A 5-page PDF of the SIN list chemical substances is available here. The proposed list of 16 substances of very high concern is available here and includes the following:

• Anthracene CAS No. 120-12-7
• 4,4′- Diaminodiphenylmethane CAS No. 101-77-9
• Dibutyl phthalate CAS No. 84-74-2
• Cyclododecane CAS No. 294-62-2
• Cobalt dichloride CAS No. 7646-79-9
• Diarsenic pentaoxide CAS No. 1303-28-2
• Diarsenic trioxide CAS No. 1327-53-3
• Sodium dichromate, dihydrate CAS No. 7789-12-0
• 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) CAS No. 81-15-2
• Bis (2-ethyl(hexyl)phthalate) (DEHP) CAS No. 117-81-7
• Hexabromocyclododecane (HBCDD) CAS No. 25637-99-4
• Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) CAS no. 85535-84-8
• Bis(tributyltin)oxide CAS No. 56-35-9
• Lead hydrogen arsenate CAS No. 7784-40-9
• Triethyl arsenate CAS No. 15606-95-8
• Benzyl butyl phthalate CAS No. 85-68-7

Click on the above link for the full article. Nexreg has more information on REACH at the following link:

• REACH Compliance Consulting

To speak to a Nexreg representative about how REACH will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
Non-Toll Free: (519)488-5126 (London, ON, Canada)
E-mail:info@nexreg.com

A useful reminder from Packaging News:

The UN’s Globally Harmonised System (GHS) on the classification, labelling and packaging of hazardous substances is to be incorporated into EU law after MEPs reached an “acceptable compromise”.

The new regulation will replace existing EU directives on classification and labelling of substances.

The aim of the GHS system is to enable products to be judged on their physical hazards and toxicity and to provide them with suitable labelling and information on safety measures, which could be through labels, hazard pictograms and words such as ‘Danger’ or ‘Warning’.

As with the current legislation, the proposed new regulation is intended to be primarily a self-classification system for businesses.

The regulation is in line with Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach) legislation, although “some small amendments” to do with classification and labelling will have to be made.

A Press Release from the EU adds:

The compromise which has been agreed between representatives of the Parliament and the Council, aims to implement the GHS system into EU legislation. The new regulation will replace the existing EU directives on classification and labelling of substances which set forth an extensive system (3 key directives), but the current rules and the GHS are conceptually similar. The proposal aims to maintain the current level of environment and health protection, to keep the scope of the classification and labelling rules as close as possible to the existing EU system and to ensure a smooth transition to a new system based on GHS. The reclassification and labelling of most substances must be completed by 1.12.2010 for substances and 1.6.2015 for mixtures. The current Directives on classification, labelling and packaging will be repealed on 1 June 2015. During a transitory period both systems will be applied.

Click on the above links for more information.

Nexreg has more information on GHS at the following link:

• GHS Strategic Planning (English)

To speak to a Nexreg representative about how GHS will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
E-mail:info@nexreg.com

From PharmTech.com:

The Synthetic Organic Chemical Manufacturers Association (SOCMA) is expressing trade concerns with the European Union’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, a new European Union policy on chemicals and their safe use…

REACH requires EU-based manufacturers and EU-based importers doing business, directly or indirectly in Europe, to register chemicals and their uses with the newly created European Chemicals Agency. Under REACH, companies will eventually be required to provide toxicity data for substances produced or imported into the EU in quantities above 1 metric ton per year. Companies will also be required to submit a comprehensive risk assessment, called a chemical safety report, covering the various uses of the materials they register. For approximately 1500–2000 chemical substances, companies will have to go through an authorization process to get permission to continue to use those substances…

One issue raised by SOCMA is in regards to provisions relating to the mandated use of a foreign-based “only representative” by a US-based company to comply with REACH. The “only representative” provision allows a manufacturer outside the European Union to appoint an EU-based company or individual to fulfill the registration obligations for products imported into the EU.

DeLisi commented on the high costs of having to use these representatives, their lack of availability and accountability, and the independence to which they are afforded to represent US businesses. Other concerns expressed about REACH were the disclosure of confidential business information, the potential to breach US antitrust laws, overall costs to companies to implement REACH, and doubts about the European Chemicals Agency’s ability to effectively administer REACH.

Click on the above link for the full article.Nexreg has more information on REACH at the following link:

• REACH Compliance Consulting

To speak to a Nexreg representative about how REACH will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
Non-Toll Free: (519)488-5126 (London, ON, Canada)
E-mail:info@nexreg.com

An article from RSC suggests that there may be a far larger number of REACH pre-registrations than expected:

The process of pre-registration of chemicals under Reach is now accelerating amidst concerns that the Helsinki-based European Chemicals Agency (ECHA), which is responsible for running the EU scheme to regulate the production and use of chemicals, may not have enough resources to do its job properly.

The agency had problems with its IT system for pre-registration when the six-month procedure started on 1 June. Substances produced in quantities of 1 tonne or more will have to be taken off the market in the EU if they have not been pre-registered by 1 December this year.

Initially ECHA insisted the IT glitch - which prevented bulk pre-registrations - would be put right by mid-June. But the tool for submitting files of up to 500 substances was not functioning until 22 July.

By late July, 4,627 companies had made 32,191 registration covering 13,883 substances on the agency’s Reach-IT online site, according ECHA figures. ECHA has calculated that there will be around 200,000 pre-registrations, for which it has taken on 200 staff to handle. However, in the next three to four months before the pre-registration deadline expires, the pace is expected to pick up considerably so that the numbers could far exceed the agency’s own estimates.

‘We think there will be at least 500,000 and even as many as 1 million,’ says Jo Lloyd, technical director at REACHReady, the Reach service set up by the UK’s Chemical Industries Association. ‘A lot more companies than expected are preparing to pre-register.’

Click on the above link for more information.

Nexreg has more information on REACH at the following link:

• REACH Compliance Consulting

To speak to a Nexreg representative about how REACH will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
Non-Toll Free: (519)488-5126 (London, ON, Canada)
E-mail:info@nexreg.com

From FlexNews:

Following a request from the European Commission, EFSA has been working since 2007 on a comprehensive evaluation of flavouring substances currently in use in the European Union.

Flavourings are divided into 48 chemical groups and EFSA is evaluating each group separately, focusing on the implications of individual flavourings for human health. Since EFSA’s update in January, the former AFC[1] Panel looked at a further 15 flavouring groups. The Panel identified data gaps for some of the flavourings including carvone-5, 6 oxide (FL-no: 16.042), butyramide (FL-no:16.049), aminoacetophenone (FL-no:11.008), 5-methylfurfural (FL-no:13.001), 2-benzofurancarboxaldehyde (FL-no:13.031). These flavourings are currently used in different types of foods, including dairy products, confectionary, meat and fish products and alcoholic beverages

The Panel concluded that data currently available were insufficient to exclude genotoxic potential of these substances and is requesting that applicants provide information that will confirm that these flavourings are safe to use in foods.

Since the beginning of the evaluation, the Panel has discussed and adopted some 70 opinions on food flavourings. Some of these 70 opinions have been published and some are now undergoing final editorial changes and will be shortly published on the EFSA website. EFSA intends to complete the evaluation of all flavourings by mid-2009.

Click on the above link for the full story. More in Future not so bright for food colourants:

But i July the European parliament took a very bold step towards that ban, by adopting a legislative package that will compel the makers of products containing any of the six artificial colours named in the Southampton study to include a health warning for children on the label.

They are tartrazine ,E102, quinoline yellow, E104, sunset yellow, E110, carmoisine, E122, ponceau 4R, E124, and allura red, E129.

The warning will read: “May have an adverse effect on activity and attention in children”.

Manufacturers have 18 months to comply with the new labelling requirements.

An important link for those interested in REACH - HPV-LPV Chemicals Information System:

This HPV-LPV Chemicals Information System provides you with information on the HPVCs (High Production Volume Chemicals) and the LPVCs (Low Production Volume Chemicals), including EU Producers/Importers lists. The content has been extracted from the IUCLID (International Uniform Chemical Information Data Base), where data have been reported by Industry.

Please select a range of CAS# or EINECS# by scrolling the above menus, each range (except the last one which contains the remaining) contains a sorted list of 300 CAS or EINECS numbers.

The current HPVCs list contains 2 782 substances and the LPVCs list contains 7 832 substances.

Click on the above link for more information.

From Marketing News:

The European Parliament has called for warnings on foods containing certain food colours to say: “May have an adverse effect on activity and attention in children”.

The Parliament has voted in favour of labelling foods containing the six food colours E110, E104, E122, E129, E102 and E124.

The move comes after research commissioned by the UK Food Standards Agency last year.

The research, known as the Southampton Study, was published last September and revealed that a combination of six food colours and one preservative increased hyperactivity in a cross section of children - not just those who had been previously diagnosed with attention-deficit hyperactivity disorder, more commonly known as ADHD.

Foods containing these six dyes will have to carry the warning label within 18 months of the official publication of the law, expected within the next few weeks.

For more information, click on the above link.

From Evertiq:

The plastics and electronics industry should be alerted to signals from the Swedish Government as restrictions of some flame retardant substances could force them into risking the fire safety of their products or into the use of less tested alternative substances. The flame retardant Deca-BDE could be banned in Sweden as early as June.

Flame retardants are substances required to be applied to a wide range of materials in order to meet Sweden’s fire safety standards (e.g. for cinemas, hospitals or other public buildings). Deca-BDE is used in applications such as plugs, cables, TV sets, carpets and furniture in public buildings or for insulation for the chemicals industry or other industry producing explosive goods.

DecaBDE has gone through a lengthy evaluation process at EU level lasting 12 years in which Sweden was involved. As a result of this evaluation, the EU authorities agreed that no restrictions on the use of this flame retardant would be necessary. Sweden obviously ignores and goes against this decision by proposing a ban. Both the European Commission and several other EU Member States have opposed the Swedish Government’s actions regarding their violation of the fundamental principles of the free movement of goods within the EU internal market. Such a ban will serve as a dangerous precedent for other substances, such as TBBPA, the flame retardant used in FR4-boards, for which restrictions have been announced for the Autumn.

Click on the above link for more information.

From the ECHA:

In the framework of the authorisation process, Member States Competent Authorities or the European Chemicals Agency (ECHA), on a request by the Commission, may prepare Annex XV dossiers for the identification of substances of very high concern (SVHC).

Substances of very high concern are defined in Article 57 of Regulation (EC) No 1907/2006 (“the REACH Regulation”) and include substances which are:

• Carcinogenic, Mutagenic or toxic to Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC,
• Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or
• Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters)

The Annex XV report prepared by a Member State or the Agency is available in the table below in order to inform interested parties. The interested parties have 45 days from this publication to give scientific comments on the identification of the substance as SVHC as well as further information related to exposures, alternatives substances and risks and send their comments to the Agency. It would facilitate the evaluation process of comments to receive them in English.

The 16 substances are as follows:

1. Anthracene ( CAS No. 120-12-7 )
2. 4,4′- Diaminodiphenylmethane ( CAS No. 101-77-9 )
3. Dibutyl phthalate (CAS No. 84-74-2 )
4. Cyclododecane ( CAS No. 294-62-2 )
5. Cobalt dichloride ( CAS No. 7546-79-9 )
6. Diarsenic pentaoxide ( CAS No. 1303-28-2 )
7. Diarsenic trioxide ( CAS No. 1327-53-3 )
8. Sodium dichromate, dihydrate ( CAS No. 7789-12-0 )
9. 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) ( CAS No. 81-15-2 )
10. Bis (2-ethyl(hexyl)phthalate) (DEHP) ( CAS No. 117-81-7 )
11. Hexabromocyclododecane (HBCDD) ( CAS No. 25637-99-4 )
12. Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) ( CAS No. 85535-84-8 )
13. Bis(tributyltin)oxide ( CAS No. 56-35-9 )
14. Lead hydrogen arsenate ( CAS No. 7784-40-9 )
15. Triethyl arsenate ( CAS No. 15606-95-8 )
16. Benzyl butyl phthalate ( CAS No. 85-68-7 )

Click on the above link for the full release.