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 ¿Û¿Û´«Ã½ for support in meeting the EU RoHS & requirements. ¿Û¿Û´«Ã½ 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.

¿Û¿Û´«Ã½â€™s Head of Compliance Solutions services said, “¿Û¿Û´«Ã½â€™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.â€�

About ¿Û¿Û´«Ã½:

¿Û¿Û´«Ã½ Engineering (enventure.com) is a privately-held, ISO 9001:2008 certified engineering solutions company, with full-fledged delivery centers in India. ¿Û¿Û´«Ã½ 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. ¿Û¿Û´«Ã½ 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 ¿Û¿Û´«Ã½â€™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 ¿Û¿Û´«Ã½.

¿Û¿Û´«Ã½ was able to help the Client by identifying the Gap and building a roadmap. With immense experience from similar projects, ¿Û¿Û´«Ã½ 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.  ¿Û¿Û´«Ã½â€™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.

¿Û¿Û´«Ã½â€™s Head of Data Management said, “¿Û¿Û´«Ã½ 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.â€�

About ¿Û¿Û´«Ã½:

¿Û¿Û´«Ã½ Engineering (enventure.com) is a privately-held, ISO 9001:2008 certified engineering solutions company, with full-fledged delivery centers in India. ¿Û¿Û´«Ã½ 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. ¿Û¿Û´«Ã½ 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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‘Directive 2011/65/EU’ (RoHS2 recast) focuses on the restriction of the use of certain hazardous substances in electrical and electronic equipment, thereby requiring every manufacturer selling to the EU market to re-evaluate their inventory and ensure compliance with the recast RoHS and WEEE directives.

Medical Device manufacturers are obligated to ensure and demonstrate compliance with the directive. The implications of Non-Compliance to the RoHS2 directive are grave and will prevent the product from carrying a ‘CE’ mark and eventual removal of the product from the market.

In order to demonstrate compliance to the RoHS2 recast, Medical Device Manufacturers are required to

1. Define their product and identify the directives applicable to it
2. Source RoHS compliant material from suppliers & analyse and identify material changes needed to comply with the RoHS2 directive
3. Show proof of compliance to RoHS2 recast by drawing up required technical documentation surrounding their product including conformity risk assessment report, test reports for each part
4. Cite relevant harmonized standards applicable to the device
5. Maintain a register of non-conforming products
6. Provide explanations as to why certain parts do not include test reports
7. Analyze their internal production and implement an appropriate internal production control procedure in line with the recast
8. Draw up an EC declaration of Conformity and affix the ‘CE’ mark on the finished product
9. Be wary of new materials introduced to the medical equipment and ensure that the equipment is tested & re-certified
10. Include a complete evaluation of the product against the list of Restricted Substances by 2014

Medical Device Manufacturers now facing the daunting task of understanding the RoHS2 directive, identifying the rules and regulations impacting their products and providing relevant documentation to demonstrate full compliance. Medical Device Manufacturers have to get comfortable with requirements of RoHS2 directive as fast as they can in order to maintain their competence in EU market.

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It is important that the significance of Children’s play toys are recognized as modern European societies face various economic, social and environmental challenges.

Children’s play toys have a vital role in this modern world. To improve the intellectual and physical growth in children toys are essential. We can even say that toys are the intimate friends of children. Many countries have implemented rigorous safety measures on toys as most of the children who play with these toys are under the age of 5. Compared to adults, children are more sensitive to chemicals and their bodies should never be exposed to hazardous chemicals or materials.

Chemicals are used in toys mainly to make them softer. There are certain chemicals that have been identified as hazardous and they are strictly prohibited from use during the manufacturing processes for toys. Therefore there are regulations created to control and forbid the use of hazardous chemical substances in toys.

In July 1989, the British government adopted the EEC toy safety directive ( 88/378/EEC) and this regulation came in to effect on the 1st of January 1990.This directive ensures that there is free circulation of toys and all these toys are required to have a CE marking along with the name and the address of the first supplier.

In 2012, a final report was prepared for the European Commission, which revealed that some of the member states had argued stating toys, irrespective of whether their primary function uses electrical energy, they are under the scope of RoHS as these toys are under the category 7 of the WEEE Directive. These Member States are known to have considered all toys that use electrical energy to fall under the scope of RoHS. For MS national legislation all EE toys, including the secondary function toys have been under the scope of RoHS and consequently the expectation is that the national requirement may be that all EE toys must be RoHS 2 compliant by January 2013.

The original toy directive that is 88/378/EEC was published in 1988. The EC (European Commission) reviews and updates this directive periodically to ensure that it achieves its objectives. Recent technological developments in the toy industry have raised new issues with regard to the safety of toys in areas such as noise, chemicals, and choking hazards. As a result, a newer EU Toy Safety Directive named 2009/48/EC was introduced to strengthen and update the rules on toy safety. This directive (2009/48/EC) was adopted on May 11 2009 by the European commission and this came into effect on the 20th of July 2011.

Benefits of RoHS EU Toy Safety Directive

RoHS, an environmental directive, is independent from the EU Toy Safety Directive (2009/48/EC) and may be it would apply to all Electrical and Electronic Equipment, but EE toys are definitely included. In its recast, which is known as RoHS 2, the scope extends from toys with a primary electrical function (RoHS, Category 7) to all EE toys, including those whose electrical function is only secondary to the overall play value. For example, a cuddly toy that talks – its primary function as a cuddly toy was exempt by a guidance document from RoHS 1, but now it will fall under the scope of RoHS 2 because it is electrically powered to fulfill this intended function.

Nitrosamines and nitrosatable substances shall be prohibited from use in toys that are intended to be used by children who are under the age of 36 months, or in other toys that are meant to be placed in the mouth if the migration of these substances are equal to or higher than 0.05 mg/kg and 1 mg/kg for nitrosamines and nitrosatable substances respectively.

Although the overall level of in the EU is high, some of the product categories are problematic. According to all enforcement reports, the biggest problem is the presence of lead in imported electrical toys. In proportion to the Commission’s knowledge, the member states will control those activities that are focused on sold equipment and not on components, as the RoHS restrictions apply to the finished product.

The Toy Industry Association supports and facilitates trade between the United States and the European Union. Mutual recognition could address most of the divergences in regulations that would burden companies who sell to both the markets while reinforcing consumer confidence that toys compliant with either standard can be trusted as safe for children. Moreover, establishing a strong regulatory cooperation agreement will ensure a joint U.S. – EU leadership in international regulations.This provides a basis for future trade agreements and also helps to provide a benchmark for the development of other standards pertaining to other countries.

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RoHS, WEEE and REACH EU regulations don’t just affect companies based within Europe – they affect any company trading with the European Union. What is more, many other markets are now governed by laws related to those within the EU. RoHS and REACH compliance have become global issues, making environmental compliance management mandatory for engineering firms, even those trading at a local level.

When considering environmental compliance management, you have to consider world conflict and political issues, as well as the harm your products may be doing to the environment. For example, is your company guilty of using conflict minerals? This has nothing to do with the REACH directive, but with the Dodd–Frank Wall Street Reform and Consumer Protection Act, which was signed by President Obama in July 2010, and came into effect in April 2011.

The Act called for a sweeping reform of the US financial regulatory system, which among other things required that any company listed on the US Stock Exchange must declare any Conflict Minerals mined in the DRC zone. In other words, any minerals mined in the Democratic Republic of Congo, and adjoining African countries suffering armed conflict.

With so many global mandates now in force, many engineering companies are turning to us at ¿Û¿Û´«Ã½ Technologies. We offer a comprehensive range of environmental compliance services which cover everything from to the Dodd–Frank mandate.

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The ELV directive was introduced to address the impact that dismantled end of life vehicles have on the environment, with regard to toxic waste reaching landfill sites. It was issued in line with the WEEE/RoHS directives, and among other things placed strict limits on the levels of lead, mercury, cadmium and hexavalent chromium to be used in the design and manufacture of motor vehicles and their components.

This made things extremely difficult for many automotive design engineers, who found the new rules unfeasible for certain system designs and engineering applications. Evidently, the message reached the right people, because on March 30, 2011, Annex II of the ELV directive was unveiled. This is a list of ELV exemptions, which acknowledges the fact that the use of the four heavy metals mentioned above is technically unavoidable for certain components and materials.

The new exemptions make regular data cleaning an essential part of your environmental strategy, as the exemptions are periodically reviewed to see if they are still warranted, in a process known as ATP, or Adaptation to Technical Progress.

We at ¿Û¿Û´«Ã½ Technologies offer targeted environmental compliance solutions for the automotive engineering industry, ensuring you are always up-to-date with the latest WEEE, and ELV compliance changes.

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The RoHS and WEEE directives have become global acronyms, generic terms for the regulation of hazardous materials used in electrical and electronic equipment, and for its disposal. Each country and state manages its criteria differently. Therefore, you should not assume that outside the EU mirrors that within it.

The California SB 20/SB 50 statutes were introduced in January 2007, under the California Electronic Waste Recycling Act of 2003. Although similar to the EU directives, the Californian versions have important differences which those exporting printed circuit boards and other EEE products to the European Union must be made aware of.

Although the SB 20 ruling has banned the sale of electronic devices prohibited under the EU RoHS directive, this is across a far narrower range of products and materials. It covers only the four heavy metals (lead, cadmium, hexavalent chromium and mercury), and applies only to CRT, LCD and plasma screens which are diagonally four inches or larger across.

There have been some changes to bring Californian RoHS more inline with that of Europe. For example, the SB 50 ruling has extended the range to include manufacturer-refurbished products. In 2010, the Lighting Efficiency and Toxics Reduction Act brought lamps and bulbs into the picture – adding another tier of complexity!

Being WEEE/RoHS compliant is a minefield wherever your business is located. We at ¿Û¿Û´«Ã½ Technologies offer a full range of to help you cope.

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The problem with omitting lead from tin solders is that, in its absence, spontaneous crystalline ‘whiskers’ can form. Electrically conductive, they can take anything from a few days to several years to develop, and sometimes (no one knows why) don’t grow at all. They can bridge contacts, short electrical circuits, and bridge traces, and no printed circuit board or VLSI design is exempt. In a piece of military (or civil) avionic hardware, the results can be catastrophic.

There is currently no fail-proof way to test the susceptibility of new PCB designs to whiskering, no way of predicting its occurrence, and no guaranteed prevention, except a minimum 3% lead addition. Many of the hardware systems using embedded firmware – for example, military applications – are exempt from environmental legislation. However, in a predominantly OTS (off-the-shelf) industry, component manufacturers aren’t prepared to start making specialist one-off products. It costs them money.

Can we live without lead solders? It seems we may have to. The race is on to find suitable alternatives, but in the meantime, those still using traditional lead-containing components will find them harder and harder to obtain. Part obsolescence management and PCN alerts are just two of the solutions we at offer, to help you cope with problems caused by environmental compliance.

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