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Bis(2-Ethylhexyl) phthalate (DEHP): max 0.1%:

DIBP is an odorless plasticizer and has excellent heat and light stability. It is the lowest cost plasticizer for cellulose nitrate and is widely used in nitro cellulose plastic, nail polish, explosive material and lacquer manufacturing etc

Benzyl butyl phthalate (BBP): max 0.1%: BBP is a phthalate that is mainly used as an additive for plasticising PVC , perfumes, hair sprays, adhesives, glues, automotive product and vinyl floor coverings etc. At present, BBP is banned in all toys and childcare articles ( European Directive 2005/84/EC) and in cosmetics which includes nail polish as it is considered to be carcinogenic, mutagenic and toxic to reproduction.

Dibutyl phthalate (DBP): max 0.1%: Dibutyl phthalate (DBP) is a commonly used plasticizer and is found naturally in small quantities in cloves. It is soluble in various organic solvents, e. g. in alcohol, ether and benzene and suspected to be an endocrine disruptor. It is also used as an additive to adhesives,printing inks and as an ectoparasiticide (drugs which are used to kill the parasites that live on the body surface).

Diisobutyl phthalate (DIBP): max 0.1%:

DIBP is a phthalate and an additive used to keep plastics soft or more flexible (plasticiser), often in combination with other phthalates.DIBP has very similar properties to DBP which was banned in toys and childcare articles as well as in cosmetics, it may therefore be used as a substitute for instance in PVC, paints, printing inks and adhesives.

Grace Periods are given to DEHP, BBP, DBP and DIBP as they will be restricted from 22 July 2019 for all electrical and electronic equipments apart from medical devices, monitoring and control equipment which will have an additional two years to comply by 22 July 2021.These are chemicals which are added on top of the existing list which consists of the following

Cadmium(Cd): 0.01%;Mercury: 0.1%;Lead(Pb) : 0.1%;Hexavalent chromium (Cr6+) : 0.1%;Polybrominated biphenyls (PBB): 0.1 %;Polybrominated diphenyl ethers (PBDE): 0.1 %.

It shall be noted that above maximum concentration values apply to each homogeneous material rather than a product or a part itself. Here for instance a homogeneous material means material of uniform composition throughout which cannot be mechanically separated into different materials.Some electrical and electronic products are out the scope of EU . Military equipment, large-scale stationary industrial tools, large-scale fixed installations, active implantable medical devices, and photovoltaic panels are excluded from RoHS.Batteries and package materials are also out the scope of RoHS since they are subject to different directives.In addition to that, certain applications are exempt from RoHS restrictions (For example, Cadmium in helium-cadmium lasers).

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The Client is a company that offers hardware solutions with low-to-high volume manufacturing and integration test capabilities. Their wide range of products and services encompasses industrial, automotive, aerospace/defense and military, computing/communication, medical and other markets. With their facilities in USA, Mexico and Asia, the Client provides seamless service to customers across the globe.

The Client had been in the process of developing 12 different products that were to be supplied to their European customers. Prior to delivering them to their customers, the Client had to ensure that the compliance requirements were met as per the European Union compliance directive for RoHS and REACH.

The Client approached �ۿ۴�ý for support in meeting the EU RoHS & requirements. �ۿ۴�ý performed initial BOM validation, followed by a collection of the required compliance data and Certificates of Compliance (CoC) from the Manufacturers of the parts used by the Client in the 12 products.

�ۿ۴�ý’s Head of Compliance Solutions services said, “�ۿ۴�ý’s systematic approach and expertise in the field has undoubtedly encouraged the Client to make their decision in favour of awarding the project to us. Our team has experience in handling similar projects and is able to efficiently identify the customer’s exact needs and provide a suitable solution. Our expertise in direct sourcing of information from Manufacturers, maximizes parts coverage and reduced any gaps in compliance.”

About �ۿ۴�ý:

�ۿ۴�ý Engineering (enventure.com) is a privately-held, ISO 9001:2008 certified engineering solutions company, with full-fledged delivery centers in India. �ۿ۴�ý has been serving clients in North America and Europe since 1997 and is today a preferred supplier of engineering and master data management services to Fortune 500 companies, across different industry verticals such as hi-tech electronics, oil & gas, water treatment, automotive and industrial manufacturing. �ۿ۴�ý provides a wide variety of services to Clients, in areas such as Plant Design Engineering, Building Engineering, Product Design, Mechanical design, Technical Documentation, Component Engineering, Environmental Compliance Support and Master Data Management.

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The Client manufactures NDE solutions based on integrated multi-method technologies for the power generation industry. Their solutions include turn-key systems, instrumentation, software products and supplies, as well as calibration, repair, training, and inspection services. They offer eddy current inspection systems, ultrasonic testers, robotics, scanners, and probes, as well as calibration services, repair and service, training courses in eddy current testing, consulting services, and field services.

The Client was planning to implement a compliance program for their strategic products and services for the European market. To achieve this, they sought a partner who could help with meeting the EU compliance requirements; including assessing the current level and designing a roadmap. Based on �ۿ۴�ý’s proposal of a comprehensive solution tailored to the Client’s needs, taking into consideration generic situations that could arise, they decided to assign the project to �ۿ۴�ý.

�ۿ۴�ý was able to help the Client by identifying the Gap and building a roadmap. With immense experience from similar projects, �ۿ۴�ý worked with the Client to meet the compliance audit trial requirement through data collection, and validation of the same with respect to the compliance directive.  �ۿ۴�ý’s team helped the Client develop a strategic approach towards building the compliance status for their different products, and ensured their strategic products meet the EU compliance requirement.

�ۿ۴�ý’s Head of Data Management said, “�ۿ۴�ý has tremendous amount of experience enabling customers identify what their compliance gaps might be and chalking out a road map to get compliant. We are very happy to have been selected by this industry leader and look forward to working with them.”

About �ۿ۴�ý:

�ۿ۴�ý Engineering (enventure.com) is a privately-held, ISO 9001:2008 certified engineering solutions company, with full-fledged delivery centers in India. �ۿ۴�ý has been serving clients in North America and Europe since 1997 and is today a preferred supplier of engineering and master data management services to Fortune 500 companies, across different industry verticals such as Hi-tech Electronics, Oil & Gas, Water Treatment, Automotive and Industrial Manufacturing. �ۿ۴�ý provides a wide variety of services to Clients, in areas such as Plant Design Engineering, Building Engineering, Product Design, Mechanical Design, Technical Documentation, Component Engineering, Environmental Compliance Support and Master Data Management

The post �ۿ۴�ý wins Compliance Consulting, Gap Assessment Project and RoHS 2 Compliance Services Project appeared first on �ۿ۴�ý.

Our Client was planning to implement a compliance program for their for the European market. To achieve this, they sought a partner who could help with meeting the EU compliance requirements; including assessing the current level and designing a road-map. Based on �ۿ۴�ý’s proposal of a comprehensive solution tailored to the Client’s needs, taking into consideration generic situations that could arise, they decided to assign the project to �ۿ۴�ý.

�ۿ۴�ý was able to help the Client by doing an initial compliance consulting engagement, to identify the RoHS 2 compliance requirements for their product categories, do a Gap Analysis and build out a roadmap. With immense experience from similar projects, �ۿ۴�ý worked with the Client to meet the compliance audit trial requirement, yb collecting required declarations and material data from Suppliers, and validating the data with respect to the RoHS 2 compliance directives.  �ۿ۴�ý’s team helped the Client develop a strategic approach towards building the compliance status for their different products, and ensured their strategic products meet the EU compliance requirement.

�ۿ۴�ý’s Head of Compliance solutions said, “�ۿ۴�ý has tremendous amount of experience enabling customers identify what their compliance gaps might be and chalking out a road map to get compliant. We are very happy to have been selected by this industry leader and look forward to working with them.”

About �ۿ۴�ý:

�ۿ۴�ý Engineering (enventure.com) is a privately-held, ISO 9001:2008 certified engineering solutions company, with full-fledged delivery centers in India. �ۿ۴�ý has been serving clients in North America and Europe since 1997 and is today a preferred supplier of engineering and master data management services to Fortune 500 companies, across different industry verticals such as Hi-tech Electronics, Oil & Gas, Water Treatment, Automotive and Industrial Manufacturing. �ۿ۴�ý provides a wide variety of services to Clients, in areas such as Plant Design Engineering, Building Engineering, Product Design, Mechanical Design, Technical Documentation, Component Engineering, Environmental Compliance Support and Master Data Management.

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As a symbol, CE mark is familiar for everyone as it has been a mandatory requirement for many years on products sold in the European Union. After the recast of the , it has also become the proof of conformity of the product to the European RoHS directive. The mark must be displayed on the product visibly, legibly and indelibly. Manufacturers, importers and distributors are responsible for ensuring that the mark is properly placed on EEE.

The CE marking indicates a product’s compliance with EU legislation. By affixing the CE marking to a product, a manufacturer declares his sole responsibility, that the product meets all the legal requirements, which means that the product can be sold across the European Economic Area.

RoHS 2 brings about a few other significant changes related to the broader scope of the directive which has implications on the legal responsibilities of businesses. Some of these changes affect manufacturers directly, as they are required to:

• Issue a signed Declaration of Conformity (DoC).
• Create a technical documentation file as per EN 50581:2012 or equivalent standards that meet requirements of module A of Annex II to decision 768/2008/EC.
• Accept analytical material test results as per the IEC 62321 Standard.
• Keep the DoC and technical documentation file for a longer period after the product has been placed in the market.

Obtain the CE marking, to prove RoHS 2 compliance.

Obligations for medical device manufacturers

Now, since the medical devices also fall within the scope of RoHS2 directive (2011/65/EU), Medical Device manufacturers are obligated to ensure and demonstrate compliance with the directive.

If a medical device is correctly CE marked and has the relevant documents for verification, the product does not need any additional approval or certification to be marketed in the European Union (EU), European Economic Area (EEA) or Switzerland as CE marking allows free movement of goods in these states.

The CE mark is a legal designation that the manufacturer’s product has met the requirements of all relevant Medical Device Directives as laid down by EU (93/42/EEC or 90/385/EEC or 98/79/EC).

In order to demonstrate compliance with the RoHS 2 recast, Medical Device Manufacturers are required to

•  Define their product and identify the directives applicable to it.
•  Source RoHS compliant material from suppliers, analyze and identify material changes needed to comply with the RoHS 2 directive.
•  Show proof of RoHS 2 compliance by drawing up required technical documentation surrounding their product including conformity risk assessment reports, test reports for each part.
• Draw up an EC declaration of Conformity
• Affix the ‘CE’ mark on the finished product and start to sell.

CE Marking is now a mandate for , manufacturers must draw up the required technical documentation, carry out an internal production control procedure, draw up an EC declaration of conformity and affix the ‘CE’ mark to their product.

It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the declaration of conformity and to affix the CE marking to a product. Distributors must check that the product bears the CE marking and that the requisite supporting documentation is in order. If the product is being imported from outside the EEA, the importer has to verify that the manufacturer has undertaken the necessary steps and that the documentation is available upon request.

According to the other Medical Device Directives in the EU, subject to the type of the device, manufacturers require to have their quality systems and technical documentation reviewed by a Notified Body before they can place their products on the market as part of the conformity assessment procedure.

However, RoHS 2 outlines surveillance responsibilities of member states but does not contain a mandate for Notified Body assessment of compliance with the RoHS 2 provisions. Only products which are designated as high risk to public interest require conformity assessment by a Notified Body. Unless there are grounds for suspecting that a device may pose a risk to public health, member states must not create any obstacles to the placing on the market or the putting into service of any medical devices as defined under the Directive bearing a legitimate CE marking.

Since most of the CE standards that apply to products are harmonized, entry of the product into EU market only requires conformance to a single set of standards, this simplifies the process of entering the EU market for medical device manufacturers and also demonstrates the importance of obtaining the ‘CE’ mark.

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With RoHS 2 directive established, it is important to know what constitutes the documentation for the compliance.  It is impractical for manufacturers to do their own chemical testing at homogenous material level to identify the presence and concentration of restricted chemicals. Instead the most prevalent and advised methodology is to work with the suppliers of the parts to manage compliance and compile evidences by collecting a set of technical documentation.  This methodology is well accepted by industry and all enforcement authorities.

EN 50581:2012 Standard

European Union has published the 50581: 2012 standards to give clarity on the technical documentation required for the assessment of electrical and electronic products with respect to the restriction of hazardous substances.  This standard reconfirms that the methodology of collecting technical documentation from manufacturers of parts is an acceptable mode of handling the compliance process.

What constitutes a technical documentation?

As per the standard, the technical documentation should contain a minimum of the elements outlined below:

• A general description of the product

(This should also assess in which product category it falls under- This evaluation will determine the applicability of certain exemptions available)

• Documents for material, parts and assemblies/sub-assemblies
• Information showing the relationship between technical documents and corresponding material, part, assemblies/sub-assemblies
• List of harmonized standards used to establish technical documentation

What tasks should a manufacturer do?

A manufacturer should do the following task to be and stay in compliance

• He has to determine the information needed for compliance
• Collect the information needed to declare compliance
• Evaluate the information with regard to quality and trustworthiness to include in technical documentation
• Maintain the technical documentation up to date and valid

Implementing each of this step requires clear understanding of process required in each of this stage.  If you are in an industry which got included in RoHS recently,  and implementing this process for the first time in your company, then you should put in necessary  effort to understand applicability of the regulation for each of your product and then implement each of these steps to manage your effectively.

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