ESA Summary Overview of API 682 4th Ed.

February 2021

This document is a very short overview of API 682 4th Ed. It highlights some areas where there can be misinterpretation of the standard. A more detailed document, along with references, is available in the Members Area.

ESA Position Statement on use of carbon/graphite face materials for mechanical seals in food contact

November 2020

Regulation (EC) No 1935/2004 provides a harmonised legal EU framework for general principles of safety and inertness for all Food Contact Materials (FCMs). It does not cover carbon/ graphite face materials as used in mechanical seals, but customers of seal suppliers are increasingly requesting certification that seals conform to the regulation.

To determine a possible migration limit for carbon/ graphite seal face materials the analytic laboratory of SQTS (Swiss quality testing services) was enlisted by the Mechanical Seals Division of the ESA to carry out benchmark migration tests.

The test program showed that carbon or graphite face materials for mechanical seals will perform to stringent limits which are already defined in EU 10/2011 for plastic materials in contact with food as well as Swiss food regulations. The materials from four different suppliers showed similar overall migration values lower than 10 mg/dm² or 60 mg/kg food.

IECEx Explosion Protection Procedures for Mechanical Seal Manufacturers (Overview)

September 2020

Process plants may contain hazardous areas where explosive atmospheres are present. Equipment applied in these areas has to be designed and approved to cover applicable safety requirements. This document has been produced by the ESA and provides a comparison of the IECEx and ATEX standards. Legislation and regulations designed to mitigate this risk are similar but are not interchangeable and application depends on geographical location and local safety regulations.

In practice the technical/ quality assurance requirements for ATEX & IECEx are identical but the methodology and route of demonstrating compliance are different.

The leading directive in the EU is ATEX, as it contains general requirements for products in the EU, and its application is legally binding across the EU. As such, IECEx certification cannot be applied as a replacement for these known and recognized conformity assessment procedures and it remains a voluntary system.

The full document can be requested by contacting the ESA on info@europeansealing.com.

UKCA Overview

May 2021

This document presents a very short overview of changes to the way goods can be placed on the UK market from the EU and on the EU market from the UK following the Brexit process.  

It covers three primary areas:

  • Placing manufactured goods on the market in Great Britain from 1st January 2021
  • Placing manufactured goods on the EU market from 1st January 2021
  • Using the UKCA mark from 1st January 2021

Further information can be requested by contacting the ESA on info@europeansealing.com.

The ESA Position Statement regarding PFAS

July 2020

Members of the ESA strive to minimise the emissions from process machinery by providing state-of-the-art sealing materials. In addition, the emissions and contamination during the production of the sealing materials and from the materials itself are kept as low as possible. A critical and widely used component for the use in sealing products are fluropolymers including PTFE dispersions and powders. Their main advantage is the high chemical resistance and very good sealability. This type of seal is helping the industry to reduce leakage and therefore keep environmental pollution to a minimum.

Our members purchase these components from reputable sources which claim that their products are PFOA free. Analysis of end products including PTFE yarns, braided PTFE packings and PTFE gaskets has shown that the levels of PFOA in the final product is below the REACH threshold of 25 ppb. For PFOS the level in the finished product is far below 0,1 % by weight. Regarding the other chemicals in the PFAS group there are no specific values available but testing for other substances is ongoing. However, in most cases other related PFAS chemicals should have been removed from the finished sealing product after processing.

More information about PFAS can be found on Youtube posted by Simon Roberts. He has a PhD in Environmental Chemistry and Toxicology and conducted PFAS research. A basic introduction about “PFAS Nomenclature, Acronyms, and Structures” can be found using the link https://youtu.be/bVlZVCXe698. More information is presented in the three part series “Three Things to Know About PFAS: Part 1 Persistence” https://youtu.be/K9LYfbuVFf8. Information about PFAS Analysis can be found under https://youtu.be/3BISPfoa-Dc.

In July 2021 the Fluid Sealing Association issued an executive statement about PFAS which can be accessed using the following link PFAS Chemicals Explained FINAL.

Another detailed and resourceful position statement was issued by BDI, the Federation of German Industries, in September 2021 – Position_BDI_PFAS.

HS Codes Position Statement

May 2021

The FSA and ESA organisations have been active with trade representatives working on the Environmental Goods Act (EGA). This act is an attempt to help the environment, by agreeing that products which are dedicated to improving the environment, should be traded freely on a global basis.

Products are agreed by the HS code definition for the product. HS codes are used by customs and excise departments to ensure the correct import duties are attached to each product.

So for products to be added to the EGA, the HS codes needed to be investigated. This entailed a working group of FSA and ESA members who conducted an exercise to ensure each sealing device was given the correct HS code.

The basis for the research was the international codes definitions in the UN comtrade database, and in the case of gaskets, the US Customs and Borders agency definitions for gaskets. These documents enabled the group to come up with the correct definition for each product.

The only really contentious issue was for AF sheet based gaskets where we agreed these should be defined as “synthetic inorganic materials, glass, aramid and mineral fibres, charged with fillers, and bonded with elastomers”.

The result of this groups work resulted in a table of sealing devices and their correct codes:


The ESA Position on European Directive DWD 98/83/TC

 1.    Background

Feb 2017 Revision of the Drinking Water Directive


The aim of the directive is to ensure that European citizens enjoy good quality drinking water in line with the World Health Organisation (WHO) requirement that all citizens have a right to safe drinking water.

There have been several attempts to create a single Europe wide standard in compliance with the Drinking Water Directive DWD 98/83/EC. In 1998 an initiative under the European Acceptance Scheme (EAS), with work carried out under the auspices of the European Commission (DG Enterprise), was started. This had the aim of harmonising the assessment schemes of products in contact with potable water in line with Article 10 of the Drinking Water Directive (DWD). The target was to bring greater harmonization by combining the Drinking Water Directive and the Construction Products Directive.  In particular the EAS was to standardise the quality assurance of treatments, equipment, and materials in contact with drinking water.

 Mandate 136

This mandate was issued in 2001, and revised in 2006 and required the harmonisation of standards for Construction Products in contact with water intended for human consumption, transportation, storage, and distribution right to the tap. An Expert Group, Construction Products Drinking Water (EG-CPDW) was set up to help the initiative.

So member states suspended work on their own acceptance schemes while expecting the EAS and EG-CPDW to deliver a harmonised scheme.

 4 Member States (4MS)

There appear to have been too many issues associated with the EAS for potable water. The general view was that Mandate 136 was far too wide in scope, with too many political requirements to ever deliver a unified scheme, lacked the required resources, and as a result the European Commission withdrew its support for the EAS in 2006.

So the four Member States (4MS) agreed in 2007 to pursue a common approach to the assessment of products in contact with drinking water. The long-term goal of this project is to set a pilot project as the basis for future EU regulation.

The 4 member states are France (Ministere du Travail de l’emploi et de sante); Germany (Bundersministerium fur Gesundheit); Netherlands (Ministerie van Infrastructuur en Milieu); and United Kingdom (Defra – department for environment, food and rural affairs). A fifth member, Portugal, is in the process of joining the project.

The basis for the common approach was agreed as:

  • The acceptance of the constituents used in materials in contact with drinking water
  • The testing of materials and setting acceptance levels
  • The specification of tests to be applied to products
  • Reviewing factory production control and for audit testing
  • Assessing the capabilities of certification and testing bodies

Today the four Member States still all have their own standards and acceptance tests, with the result that suppliers potentially have to have materials tested 4 times to ensure their products are accepted for use with potable water throughout Europe. (See appendix 1 for details of schemes and costs). This is patently a nonsense and a large additional cost to the suppliers, as well as creating a barrier to trade in Europe.

Members of the 4MS initiative have worked hard to agree a standard test that could satisfy everyone. At present there is no agreement between the Member States with the issues appearing to be:

  • Water sources vary dramatically across Europe and the results obtained are totally different when one material is tested using the same criteria but with different water sources.
  • There is a debate on whether it should be products that are tested or whether their constituent materials need to be approved separately.
  • One member state believes the testing should be based on the effect material has on drinking water, and not the effect of each component material.
  • The loss of income from the certified testing facilities in the 4 member states.

However despite the differences of opinion the 4MS agreed a Declaration of Intent (DOI) made in 2011, which whilst not legally binding, would appear to give the best chance of success. The objectives of the DOI are:

  • Establish convergence of the operations of the national approval systems for material and products in contact with drinking water.
  • To provide approval systems providing high uniform level of consumer protection.
  • To promote optimum use of regulatory and scientific resources.
  • To collaborate in supporting developments at an EU level and at creating consistent practice.

 CEN TC 164 WG2

In 2014 and in parallel to the 4MS initiative, the CEN TC 164 was set by the Commission in order to move towards a step-by-step approach on standards harmonization.  The group is responsible for carrying out the technical work on synchronising and detailing the tests.

The Technical committee TC 164 is well on with getting agreement on the following issues:

  • Organic materials.
  • Metallic materials.
  • Cementitious materials.
  • Other materials.
  • Test methods.

The ESA has been in contact with the chairman of TC 164, and are now an accredited Liaison Member of TC 164, and attend their technical meetings. ESA is also a member of the European Drinking Water association (EDW), formerly ICPCDW, which is also a full member of TC 164

 Article 10 of the Drinking Water Directive

DG Environment is conducting a review of Article 10 of the Drinking Water Directive, because of concerns at the lack of harmony within the EU of requirements for materials and products used in drinking water applications. ESA has formerly responded to this initiative giving details of the typical costs members encounter when having to conduct 4 versions of tests for each product to gain local approval for their use on drinking water. Details of the various costs for the 4 member state testing facilities are in Appendix 1.

Mutual Recognition

European Union of “Mutual Recognition” is a legal condition of EU membership that states that if a product or material passes an agreed test in one member state, then the other members states are bound to accept this product or material under the concept of mutual recognition.

2.    The ESA actions and current position on the European Drinking Water directives

Following a meeting on 9th March with the European Commission’s DG GROW to discuss the background and prospects of success of the ongoing initiatives around water standards the ESA has formed a policy to act on behalf of its members.

The ESA attended various meetings in Brussels and Munich to determine our best approach.

This resulted in the ESA:

  • Becoming a Liaison Member of TC 164, and participating in their meetings in Brussels.
  • Joining the European Drinking Water industry consortium (formerly known as ICPCDW), and attending their meetings in Brussels. The European Drinking Water consortium includes all the relevant Trade Associations in Europe involved in Drinking Water.
  • Being kept fully up to date with all stakeholder events and technical meetings, and meetings with national regulators.
  • Responding to DG environments review of article 10 of the drinking water directive.

The ESA’s position is that it fully supports TC 164 work on harmonising a single pan European test for products in contact with drinking water, with the removal of the cost of meeting multiple tests. If required ESA will support the “Mutual Consent” principle

Appendix 1

European Potable Water Testing

Current Standards Used

Country Standard Approval Body Life of approval Cost of Testing
France Attestation de Conformitie Sanitaire
ACS (AFNOR XP P41-250 ACS, Carso 5 Years €5000
Germany Kunstoffe und trinkwasser
KTW DVGW, Karlsruhe 5 Years €4000
United Kingdom Water Regulations Advisory Scheme £825 to £1295
WRAS/WRC BS 6920,2000 WRAS 5 Years + £325 for certificate
Netherlands  KIWA test
 ISO 17025  KIWA Test Centre  5 Years  €1200
 USA  National Science Foundation
 NSF Ansi 61  Licensed Test houses  5 Years  $2000


October 2016

The ESA published a large reference document of Best Available Techniques (BATs) in 2009 which detailed the IPPC 1996/61/EC directive and the BATs for each type of Sealing Device available.

The relevant regulation has now changed to IED 2010/75/EU, and the technologies available within sealing devices has improved over the intervening years, hence the issuing of an updated BAT for sealing Devices.

The key point is that IED 2010/75 combines and merges 7 existing directives. (IPPC (1996/61/EC and 2008/1/EC); Large Combustion Plants (2001/76/EC); Waste Incineration (2000/76/EC); Solvent Emissions (1999/13/EC); and 3 existing TiO2 directives).

The MAJOR change is that the IED now strengthens the role of BREFs and BATs recommendations and includes the issuing of Permits to allow plants to operate, and the Permit Conditions which include emission limit values for ALL POULTANTS which are to be determined in BATs. IPPCs did not include permit conditions, so IED 2010/75 is MUCH tougher, and BATs are MUCH more important documents.

The types of installations covered by IED 2010/75 are much the same (Energy Industries; Metal Industries; Mineral Industries; Chemical Industries; Waste Management; and the “Other” industries including: Tanneries; Pulp and Paper; Wood based panels; Textiles; Slaughterhouses; Food and Drink; Surface treatment with organic solvents; and  the ubiquitous Intensive Livestock Farming. All these documents focus on the process BREFs and general BATs.

The BATs conclusions are the reference for setting permit conditions and permits must contain the Emission Limit Values (ELVs) detailed in the BAT.

By their very nature BATs are dynamic and are required to be updated frequently and an 8 year minimum cycle is recommended.

The scope of the IED is heavily focused on the environment, with particular attention to:

·      Emissions to air;

·       Emissions to water;

·       Emissions to land;

·       Prevention and control of accidents;

·       Waste prevention and recovery;

·       Energy and water use;

·       And now, noise; vibration; heat; and odour.


This effectively is the working group, chaired by DG Environment in Brussels, which decides, via the expert working group (similar to the IPPC Information Exchange Forum), on the technical issues for all the new BREFs that are to be issued as part of IED. BAT conclusions are agreed by qualified majority, adopted via the implementing acts. This is similar to the Seville process of the IPPCs.

Mark Neal is a member of Article 13 forum on behalf of ESA.

There is a published list of active BREFs, and the programme of new and reviews of BREFs available from DG Environment. Recent work includes the recent draft on Large Volume Organic Chemicals (LVOC) and the Large Combustion Plant (LCP), and there has been a call for participation in the Waste Gas in Chemical Sector BREF.


ESA fully supports the concept of industry BREFs and BATs and the concept of operating permits, with emission limits set by BATs.

ESA wants to be an active member of Article 13 forum and ensure the very best sealing devices are used within the industries covered by BREFs, and to help set realist emissions targets for operating permits, based on the best Sealing Techniques being used.

ESA is committed to reducing emissions to the atmosphere, water sources and land. ESA fully supports efforts to reduce accidents, waste, energy use, water use, noise and odour.

IPPC Directive 2010/75/EU Reference documents are available at:


BAT reference Documents are available at:


ESA Position Statement on EC 1935/2004, Article 16 – Declaration of compliance for materials and articles intended to come into contact with food.

June 2016

Underlying Principle of EC 1935/2004

Article 3 of EC 1935/2004 states that materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foresable conditions of use, they do not transfer their constituents to food in quantities, which could endanger human health or bring about an unacceptable change in the composition of the food or bring about a deterioration in the organoleptic characteristics thereof.

The Members of the European Sealing Association (ESA) Mechanical Seals Division have developed the following “Position Statement” to further clarify the subject.

ESA Position Statement on ATEX Directive 2014/34/EU and its applicability to Bearing Isolator Seal

April 2016

The new Directive 2014/34/EU applies to equipment and protective systems for use in potentially explosive atmospheres and is mandatory as from 20 April 2016. It replaces Directive 94/9/EC. With this revised Directive, the essential health and safety requirements have not changed. It was the aim of the revision to harmonize the requirements with the New Legislative Framework – NFL.


The precedent Directive ATEX 94/9/EC (ATEX 95) – ‘Equipment and Protective Systems intended for use in potentially explosive atmospheres’ has been mandatory since July 1st2003. On Feb 22nd 2005, the EC ATEX Standing Committee provided a “Consideration document” on mechanical seals defining when a mechanical seal is to be considered a machinery element or an ATEX Component. Bearing Isolator seals should be considered in a similar manner to mechanical seals.

The Members of the European Sealing Association (ESA) Mechanical Seals Division have developed the following “Position Statement” to further clarify related issues.

ESA Position Statement on ATEX Directive 2014/34/EU and its applicability to Mechanical Seals.

2021 September

The new Directive 2014/34/EU applies to equipment and protective systems for use in potentially explosive atmospheres and is mandatory as from 20 April 2016. It replaces Directive 94/9/EC. With this revised Directive, the essential health and safety requirements have not changed. It was the aim of the revision to harmonize the requirements with the New Legislative Framework – NFL. In September 2021 the position statement was updated to include changes regarding Brexit.


The antecedent Directive ATEX 94/9/EC (ATEX 95) has been mandatory since 1 July 2003. The interpretation of how this Directive applies to Mechanical Seals is still largely misunderstood. On 22 Feb 2005, the EC ATEX Standing Committee provided a “Consideration document” on mechanical seals defining when a mechanical seal is to be considered a machinery element or an ATEX Component.

The Members of the European Sealing Association (ESA) Mechanical Seals Division support this“Consideration document”and have developed the following “Position Statement” to summarize its content and to further clarify related issues.

ESA Position Statement on the Machinery Directive 98/37/EC and 2006/42/EC

The new Directive 2006/42/EC was transposed from in December 2009, on the repeal of the original Directive 98/37/EC. After consultation, it is the judgement of the ESA Mechanical Seals Division that the definition on applicable “Machinery” (in either the original or new Directive) does not apply to mechanical seals. They shall be classified as machinery elements or components when applicability to the Machinery Directive is considered and conformance is not required. Further detail is available in a Position Statement, which has been developed by the Members of the ESA Mechanical Seals Division.

ESA Position Statement on the EU Pressure Equipment Directive (97/23/EC)

The ESA has sought advice from sources across Europe, including the Verein Deutscher Maschinenbau-Anstalten e.V. (VDMA, Germany) and the Department of Trade and Industry (dti, United Kingdom) regarding the implications of the Pressure Equipment Directive (PED) for mechanical seals. A Position Statement is available for clarification.