REACH - Enforcement controls / Practical tips

Practical tips to prepare yourself for a REACH enforcement authority

visit

CIR conference

7th – 8th September 2016, Nice

Dr. Roger Van der Linden

Part 1 : The position of the EU Industry

Part 2 : Cefic REACH Enforcement Group

Part 3 : Advise of authorities

Part 4 : Tips for international companies

Overview

Presentation title | 23 August, 2016 2 |

Part 1 : The position of the EU Industry


1. Position of the EU industry


Joint industry statement on REACH enforcement EC Conference on REACH & CLP enforcement

1 March 2012, Brussels

Joint Industry statement text


Summary


Industry’s expectations on REACH enforcement:

Uniform, consistent, transparent and equal enforcement of REACH across the EU…

…on both the local manufacture and use of substances, preparations and articles and the import of substances, preparations and articles

Sanctions should distinguish between deliberately and accidentally setting out to contravene REACH

Industry as well as authorities are in a learning phase of a very complex legislation

Part 2 : CeficREACH Enforcement Group


Introduction


• This presentation reflects the collection of real-life experiences from a limited number of companies active in the Cefic Enforcement group

• It is also based on inspections that took place in: Netherlands, Sweden, Belgium, Germany, Italy, France, UK, Hungary, Portugal, Slovakia and Spain

• Most countries started REACH inspections in 2009

• We start to see some differences among countries in interpretations of the provisions of REACH

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Feedback from the inspections


• Inspections more and more mix REACH with other pieces of legislatione.g. CLP but also Biocides, PIC, environment, occ. Health, etc.

• Some questions may have impacts in virtually all departments of the company e.g. purchasing, sales, etc.

• Inspectors are clearly learning, also from industry during the inspection!

• Short introduction of the company including the general approach to manage REACH was found very useful by the inspectors (sometimes it already answers some questions!)



• In most cases inspections were announced by phone and even confirmed by letter. This is a good practice;– it allows the company to prepare,

– have the right people on-site or available on the phone, etc.

– better quality of answers and efficient use of inspectors’ time

• However, scope of the inspection was not always clear (neither from the announcement or during the inspection)

• Most questions and issues raised were relevant

• Written feedback soon after the inspection much appreciated, although not always the case. In some cases, not even oral feedback was given

Role of customs


Industry has experienced some blockage of goods at the customs due to lack of registration numbers on shipment papers:

• Registration number is not appropriate to control REACH compliance e.g. exemptions, different deadlines, etc.

• Solution was a statement of compliance but sometimes difficult procedure to release goods

• Need common procedures and appropriate involvement of customsauthorities

Role of customs


• Check of REACH compliance of imports should happen at the ‘most appropriate’ place, i.e. not necessarily exclusively at the border, but rather at the importer’s premises.

• Harmonisation among EU countries with regards to the Customs involvement is crucial

• Blockage of goods should be avoided at borders

• The inclusion of the registration number in the customs declaration is neither useful nor workable

Registration number on SDS


Availability of full registration numbers on SDS:

• In some cases authorities have requested full registration numbers where SDS included truncated ones

• Cefic model letter worked very well to communicate in the supply chain and with authorities (available on Cefic website)

Dear Supplier,……Please provide fullRegistration number to Authority…

05-1234-567-xxxx



Other remarks:

• All parties involved realise going up a learning curve

• ECHA Guidance often referred to and taken as reference

• Some issues are not really compliance issues: need to manage expectations

• Important for inspectors to highlight references to legal text for some points. If not clear, discussions may be endless

• In some cases, authorities use consultants to support them. This may be an issue in the future if confidential information is at stake

Lessons learned


The most effective and efficient inspections had:

• Announced inspections

• Scope well defined

• Relevant experts available

• Proper competence level of inspectors

• Feedback (e.g. inspection report)

Part 3 : Advise of authorities


Advise of authorities

• Authority visits are announced and unannouced:– announced: to assure that all documents and relevant experts are present

– unannounced: to check a detail in the plant

• Prepare for the following issues:– which substances, mixtures,articles do I produce, import or use in my economic activities

– what are my obligations as manufacturer, importer, downsteam user

– are all my raw materials legally compliant: registered, authorised, restricted

– do I fall under exemption regulations (polymers, intermediates, natural substances, etc)

• By announced visits the focus is clearly described– It is then also expected that preparative homework is done

• Authorities do not do an audit: they do an inspection– They prepare the visit with publicly available info, might use questionnaires and make an evaluation

• Do not invent answers– If you don’t know it, say it. If you don’t have it, admit it.

• Member companies of Federations are normally better prepared: good to join one

• Follow the website of ECHA


Part 4 : Tips for international companies


Tips for international companies

• Situation: most international companies have a dedicated REACH team– Experts, mostly chemists or toxicologists

– following daily the legislation and all its evolutions

– Following the political scene and related EU legislation

– Are member of one or more specialised federation workgroups

– Follow IT evolutions: REACH-IT, IUCLID 6, Chesar, etc, etc

• Issue: inspections happen locally, by the local authorities in the national language

• It is quite impractical for the REACH team to fly all around Europe

• Therefore a practical solution can be:– REACH team prepares for each legal entity:

• A documented list of all (pre)registrations, authorisations, (notifications), exempted substances, etc

• A documented file with all relevant customers and suppliers communication

• A track file listing all authority contacts

– Per legal entity a local REACH (or Product Stewardship) responsible is appointed

– This person is trained by the REACH team and has a monthly telcon with all his peers

– This person is trained in reading SDS and keeping the REACH file up to date


Enforcement is key for a sustainable REACH!


WARNING

23 August 2016 Presentation title 22

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REACH - Enforcement controls / Practical tips

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