Home - Claigan - REACH SVHC in the Real World...Article 33 - REACH Regulation • “Any supplier of...

Presented by:Bruce CalderVP Consulting Services

REACH SVHC in the Real WorldPractical Approaches to REACH SVHC Compliance

Wednesday, September 10, 14

Agenda• Introduction

• REACH SVHC Declaration- Definition of an article

- Challenges

- First steps

- Updating cycle

• Recommended approach- Writing a declaration

- Common REACH SVHCs

- Managing uncertainty

- Maintaining and updating

• Authorisation

• Q&A

Note - Presentation is only 50 minutes plus Q&A. Please submit questions so that we can address

your specific issues.


Claigan REACH SVHC Services• REACH SVHC

- Product level REACH SVHC declarations

• Engineering evaluation

• Data gathering

• Laboratory testing

• Experience- Wide range of professional, medical, industrial, and consumer companies

- Legrand, Danaher, Smiths Medical, Smith & Nephew, Covidien, Johnson & Johnson, Hamilton Beach, Honeywell, Hach, Fluke, Moog, Edwards Lifesciences, Instrumentation Laboratory, GE, Schneider Electric, KavoKerr, Microsemi, JDSU, Agilent, Barrx, Tyco, L-3, Smart Technologies, Pelton & Crane, Cooper Surgical, Carestream, Abbott Laboratories, Atricure, CAE, Philips, Plexus, FLIR, Trojan, Deltrol Controls, LoJack, Thermo Scientific, Li-Cor, Avid, and US Commercial Service.


Article 33 - REACH Regulation• “Any supplier of an article containing a substance

meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. “

• This is for business to business sales

• Sales to a consumer are allowed 45 days to respond- From a consumer request

- But a sale of a consumer product to a business (retailer) do not benefit from the 45 day period


Definition of an Article• Definition in dispute between EU member states

• Simplified definition- Any detachable physical item placed on the market in the EU

• Article examples (laptop)- Laptop

- Detachable power cable

- Laptop box (each packaging item is a separate article)

- Mouse

- Spare battery

- Replacement motherboard

- Case


Authorisation Explained (Simplified)

Substance recommended to

become a candidate for authorisation by EU member state or

ECHA

If unanimous agreement by EU

member states that the substance qualifies as a cat 1 or 2 CMR,

PBT, or vPvB

If approved by EU member states, the

substance now requires

authorisation to use

Substance, after a certain date, requires authorisation for use

or addition to an article in the EU

Consultation by EU Member States(once every 6

months)

Substances is added to the Candidate List

for Authorisation(SVHC List)

Proposal to add as candidate for authorisation

Addition to candidate list for authorisation list

(Now an SVHC)

Substance recommended to

become authorised by EU member state

or ECHA

Consultation by EU Member States

Addition to authorisation list

Substance requires authorisation


Challenges with Creating a REACH SVHC Declaration

• Cost- The average single test for all SVHCs is now over $2,000

• Articles- What are your declarable articles?

• Materials- Which materials are at risk of containing SVHCs and

which SVHCs are they?

• Rolling up the data- Rolling up the part data into a product declaration

• Where to start?


Creating an SVHC Declaration• Key items to account for in an initial declaration

- Which articles are require declaration?

- Which substances are likely to be in the article above 0.1% w/w?

• Substances and locations

- How do I close the gaps?

- Do I restrict or otherwise control SVHCs in my products?


First - Use Your Eyes• Instructions

- Go down to shipping

- Open up a box

- Look at what is inside

• Common situation- Handheld analyzer

- plus

• manual, lanyard, dust cover, carrying case, silica gel packet, PVC clam shell, batteries


Professional Equipment• REACH SVHC declaration is not like RoHS

- Not a restriction / ban

- Not governed by CE marking

• National authorities are extremely unlikely to crush and test a piece of professional equipment

- Have to buy the unit

- Very unlikely to have REACH SVHCs above 0.1%

- One piece of lab equipment is a lot of sandals and kids toys

• Accessories- Very different story


Key Criteria for Prioritizing SVHCs• Materials and SVHCs to focus on

- Which SVHCs are likely to be in an article above 0.1%

- In which materials would they be contained?

• Risk materials

• Identified risk materials questions- Does each risk material contain an SVHC?

- What % of the material is an SVHC?

- Do we control the SVHC content of that material?


Notable Declarable SVHCs in Articles• Phthalates (DEHP, BBP, DBP, DnHP)

- Plasticizers

- Common between 5% to 30% w/w in

• PVC, synthetic rubber, vinyl, sealants

• 1, 2-dimethoxyethane (EGDME) - Common between 1% to 4% w/w in

• Lithium manganese batteries

• Cd- Red dye in plastics

- Brass

• Cd content in not controlled in most brass alloys

- Non-issue in RoHS compliance products

• Boric acid- Silicone rubber (silly putty type)


Industry Agreements / REACH Rules• Not all materials are ‘created equal’

• Substances in polymers need to be declared- Such as PVC

• Substances in UVCB’s do not- Such as glass

• Example- PbO and B2O3 (not declarable in glass)

- Glass is classified under REACH as an UVCB substance (substance of unknown or variable composition, complex reaction products or biological material) containing the elements silica, calcium, sodium, potassium, magnesium and other cations bonded together by oxygen. These elements are bonded into a non crystalline molecular structure with completely different properties in comparison to the starting raw materials. Glass does not contain the oxidized chemicals in the different raw materials. Therefore, as diboron trioxide and lead monoxide are not present in the glass in their molecular forms, there are no applicable obligations under the EU REACH regulation with regards to communication to customers and notification to ECHA for articles containing glass, due to the inclusion of diboron trioxide (EU 215-125-8) or lead monoxide (EN 215-267-0) in REACH Annex XIV.


Phthalates• DEHP, BBP, DBP are extraordinarily common in high concentrations in

- cables

- vinyl

- strain relief

- foam handles

• Supplier knowledge

- Low to very low knowledge

- Suppliers are incorrect in phthalate content in related materials

• Close to 50% of the time

• (Based on laboratory testing by Claigan)

- Worse in low cost products

• both in terms of knowledge and chance of containing DEHP

• Unless the supplier is extremely knowledgeable, assume they are incorrect regarding phthalate content


Reasonable and Practical Approach• Reasonable approach

- Choose an effective approach

- Even if incorrect, the penalties would be lower

• penalties are supposed to be proportional to the offense

• Focus on- Identifying articles

- High risk materials

- Testing or data gathering the high risk materials

- Developing a declaration that handles the range of declarables, unknowns, and level of ongoing control


Do you control SVHCs?• Very typical situation

- You have a level of data from testing or suppliers

- but you do not control

• the material or SVHC in the materials

• Initial data may not be representative of the product on any given day or time

- Supplier may change

- Material may change

- Supplier can change content of the materials

• You need to acknowledge and manage this situation


Writing a Declaration• Recommended approach

- Write a declaration that encompasses a range of products

- Be clear and honest

- Manage uncertainty

• ‘May contain nuts’ statements

- Simplify your work

• Often it is simpler to declare than measure

• Example - EGDME in button cell batteries

• Statement should include- Industry agreements and exclusion

• PbO and B2O3


Communicating to the Customer• The declaration needs to be provided to the

customer at the time of sale (for sales to non-consumer)

- but....

• REACH regulation

- governs also MSDS (safety data sheets for chemicals)

- industry, in general, has interpreted that REACH SVHC declarations can be handled like MSDS

• Have on hand

• Provide to a customer when requested


Maintaining an SVHC Declaration• SVHC list is updated every 6 months

- Do you re-gather all of your SVHC data?

• A lot of work

• Most suppliers will not have an updated SVHC declaration

• Effective solution- Identify which of the new SVHCs

• Are likely to be in any of your products above 0.1% w/w

- Gather data for or test only the affected parts

- Normally <1% of parts and materials


Authorisation• Substances that require authorisation

- Example DEHP

• Sunset date 21/02/2015

• Cannot be added to articles in the EU after 21 Feb 2015

• How does that affect your products- For articles (physical products)

• DEHP could not be added to the article in the EU

• but, DEHP could be added

• to the article outside the EU, or

• the material (PVC) outside the EU

• and imported into the EU as an article without requiring authorisation.

• EU commission is very clear that restriction of substances in articles would be handled by other legislation such as RoHS.


Summary• REACH SVHC

- Identify the high risk materials

- Identify the high risk articles

• the power cable is higher risk than the laptop

- Prosecute those high risk materials / articles

- Manage uncertainty

- Assume that many suppliers will have no idea what they are doing

• Leverage- 3rd party specialized organization (such as Claigan)

• easier, cheaper, more accurate

- Procurement and engineering specifications

- Related compliance work

• Proposition 65


Claigan Restricted Materials Services• REACH

- Product level REACH SVHC declarations

• Engineering evaluation

• Data gathering

• Laboratory testing

• Related services- California Proposition 65

- RoHS

• Testing, data gathering, and technical files

- Conflict minerals

• World leader in due diligence and SEC disclosures

- Global requirements

• EU packaging directive, IATA lithium restrictions, EU battery directive, Health Canada (BPA), US FDA (latex), EU MDD (DEHP)

Q&Awww.claigan.com


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