ask the experts: exploring new developments with the reach regulation

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Ask the Experts:Exploring New Developments

with the REACH Regulation


Today’s Presenters

James CalderAssent ComplianceDirector, Compliance Programs

A.J. GuikemaTetra TechREACH Consultant


Assent Product Suites

Ethical Sourcing

Materials Management

Supplier Information Management

Inspections & Audit Tools

Configurable Surveys & Declarable

Substance Lists


The Assent Advantage


Reminder on REACH

REACH applies to almost all chemical products since products are either chemicals themselves or shaped into a finished product (e.g. Articles)

Requires companies to demonstrate their products are safe to humans in the environment by either:

Submission of information on chemicals to the ECHA (Registration, CLP Notification, etc)

Reducing exposure to chemicals (CLP Labeling, SDS, etc)

If chemical substances pose unacceptable risk to humans and the environment, they can be proposed as a Substance of Very High Concern (SVHC) by ECHA and/or Member States


SVHCs

First StepCandidate List of Substances of Very High Concern for eventual inclusion into Authorisation As of June 2016: 169 substances Immediate communication requirements

Second StepSubstances added to the Authorisation List (Annex XIV), the “A” in “REACH” Sunset dates to prohibit use of substances in the EEA

Third StepRestriction on the use of substances (Annex XVII) If a substance on Annex XIV has passed a sunset date and does not require

Authorisation, the natural progression is to restrict all other uses

NOTE: All steps have consultations processes


Articles Interpretation Issue

Definition of ArticleAn object, which during production is given a special shape, surface or design, which determines its function to a greater degree than its chemical composition

ECHA Guidance applied the

Article definition to

show a product made up of

many parts to be interpreted as ONE Article

Dissenting Member States did not agree

and decided to go their own way

with an interpretation of Once an Article, Always an Article

France issued their statement

to apply enforcement

Seems simple but applying this definition to every single product in circulation introduces every conceivable fringe case scenario

OAAA...or O5A if you include the indefinite article “an”

Industry associations then requested a ruling from the European Court of Justice


The European Court Of Justice Ruling

The Question‘Where an article within the meaning of [the REACH Regulation] is composed of several elements which themselves meet the definition of article given by the regulation, are the obligations resulting from Article 7(2) and Article 33 of the regulation to apply only with regard to the assembled article or with regard to each of the elements which meets the definition of article?’

Issued September 2015“the classification as an article remains applicable to any object meeting the criteria in Article 3(3) of the REACH Regulation and forming part of the composition of a complex product unless, following a production process, that object becomes waste or ceases to have the shape, surface or design which is more decisive in determining its function than its chemical composition”

Aligns with original dissenting Member States opinions


Immediate Non-Compliance?

Not a change in the Regulation, but a ruling on the interpretation of the law.

No phase-in period, but…

The European Enforcement Forum is actively cross-training on best practices for enforcement of SVHCs in Articles through 2016

• Committed to targeted enforcement of SVHCs in Articles in 2017

Non-compliance with REACH may have a grace period of enforcement

• Member States may still enforce when interpretation has always been clear

What about client contracts?• Does the interpretation put your company in immediate breach of

contract?• RoHS Exemption 7cI?


• Sunset Date • Latest Date after which substance may no longer be used

in the EU• Latest Application Date (LAD)

• 18 months prior to Sunset Date• “Use” includes:

• Import of substance• Import of substance within a preparation• Formulation of substance into a preparation within EU• Incorporation of substance into an article within the EU

• “Use” does NOT include importing an article which already contains the substance

Authorization: Phase-out of Substance


31 substances currently on Annex 14 at : www.echa.eu

Authorization

http://www.echa.eu/


Timeline for Substance Authorization

Member States

Commission

Commission

Annex 15

dossier

Add substance to Candidate List

Add substance to Annex 14 Grant or deny authorization

Candidate List

Annex 14

Apply for Authorization

Member States

Authorisation decision

Approx. 6 months

Prioritisation

draft recom-

mendation

Approx. another 6-12

months

Recommendation

Public consultation

up to another 2 years

Public consultation

Public consultation

RAC SEAC

Commission


Final opinions

Public consultation

Draft opinions

max10 months

Submission

1-4 months

Comments and responses published

Final opinions published

Commission Decision

2-3 months

Invoice paid = date of receipt

Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC)

develop opinions

« Trialogue »~ month 3

Applicant can comment

Broad Information on Use published

8 weeks

Draft opinionsDraft opinions

PSIS 6-9 months earlier

Timeline: The Main Steps After Submission


Restriction

Massive list of substances captured under Annex XVII of the REACH Regulation

Scope A restriction applies to any substance on its own, in a mixture or in an article,

including those that do not require registration It can also apply to imports

Where is the Restriction List? Captured under 64 entries on annex XVII (as of June 2016)

Does not mean only 64 substances are restrictedFor example: Entry 61 includes one substance (Dimethylfumarate DMF) in all Articles at

0.1% w/w Hmmm, remember that “Article Interpretation”?

Entry 19 includes arsenic compounds restricted in a variety of uses 140+ substances in this one entry


How are Restrictions Enforced?

Inspections at port of entry After-market surveillance Example of REACH Enforcement June 24, 2016

Shoes being sold in Estonia

Risk: Chemical The amount of Chromium (VI) in the leather of the shoes is too high (measured

value: 13 mg/kg). Chromium (VI) is sensitising and may trigger allergic reactions. The product does not comply with the REACH Regulation.

Measures taken by economic operators: Recall of the product from end users (By: Retailer)

Entry 47 of Annex XVII includes: Leather articles coming into contact with the skin shall not be placed on the market

where they contain chromium VI in concentrations equal to or greater than 3 mg/kg (0,0003 % by weight) of the total dry weight of the leather


Restriction Enforcement Details for 2015

In 2015, there have been 2123 notifications on non compliance to the Rapid Alert System for Non-Food Products (RAPEX).

#1 type of notifications originate from chemical non-compliance (25%)

Until recently, injuries have held the #1 place for notifications

Enforcement targets high risk products due to type and country of origin


Summary


[Webinar] Ask the Experts: China RoHSThursday, June 30th | 1PM

Upcoming Educational SummitsOctober 20, 2016 | ChicagoNovember 17, 2016 | BostonFebruary 8, 2017 | San Jose

Joint Materials Management Conference with Tetra TechDecember 1, 2016

Upcoming Events: Webinars & Conferences

More details to come at:www.assentcompliance.com/events

http://www.assentcompliance.com/events

http://www.assentcompliance.com/events


Any Questions?

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