Legislation is the biggest driver to the formulator; ensuring that all products meet current legislation in the countries of use while trying to predict interpretation of developing legislation.
Legislation affecting detergents and disinfectants is numerous; but three new pieces of legislation are and will have a major impact on the supply and use of products. REACH, BPD and CLP are all significant pieces of legislation.
Classification Labelling & Packaging (CLP)
New regulations apply to substances from December 1st 2010. For mixtures the change will be phased in over five years. The most obvious changes to Labels and Safety Data Sheets will be the disappearance of Orange Squares, Risk Phrases & Safety Phrases; replaced with Red Diamonds, Signal Words, Hazard Statements and Precautionary Statements.
Current situation
Currently safety datasheets are compiled according to UK implements of either the European Dangerous Substances Directive (No. 67/548/EEC), or the Dangerous Preparations Directive (No. 1999/45/EC). These safety data sheets allow a clear distinction between non-classified, irritant and corrosive chemicals, but all is about to change.
Outside the EU, there are numerous different classification and labelling systems. For example; whereas in the US, a chemical may be classified as “Toxic”, the EU classification may be just “Harmful”. The chemical industry relies on worldwide trade, this confusion makes assessing the safety of chemicals difficult. Members of the United Nations have agreed on a Globally Harmonized System of Classification and Labelling of Chemicals. In the EU this is implemented as Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging (CLP) and will replace the DSD and DPD system of classifications.
Changes
The most obvious changes to Labels and Safety Data Sheets will be the disappearance of the well understood Orange Squares, Risk Phrases and Safety Phrases, these are to be replaced with Red Diamonds, Signal Words (such as Danger or Warning), Hazard Statements and Precautionary Statements. There is no direct correlation between the systems. Sometimes products that are currently classified as Irritant may move to become Corrosive.
The new regulations apply to substances from December 1st 2010, but for mixtures the change will be phased in over five years. Most products supplied by Holchem (but not all) are mixtures.
Holchem do not manufacture substances. We will be guided by information from our suppliers and will review products that may be considered as substances in December 2010 and January 2011. If necessary we will issue new safety data sheets and apply the new labelling rules. However, for stock that is already in a warehouse, there is a two year derogation before it has to be relabelled.
Holchem currently has no plans to bring forward the 2015 deadline for reclassifying and labelling mixtures, but will review this position periodically. Other detergent suppliers may choose to operate on different timescales. Holchem will continue to actively review safety data sheets and re-issue in the appropriate format as new information becomes available from suppliers.
Please contact Holchem’s Technical Centre for further information.
Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH)
The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced. The benefits of the REACH system will come gradually, as more and more substances are phased into REACH.
REACH is a new European Community Regulation on chemicals and their safe use HYPERLINK "http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907:EN:NOT" \t "_blank" . It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The new law entered into force on 1 June 2007.
REACH will place responsibility on industry to manage the risks from chemical substances, and to provide sufficiently detailed safety information to allow safe use of chemical substances. Through this, the aim is to provide improved protection to human health and the environment. It is also expected that the EU chemical industry will benefit from enhanced competitiveness and innovation.
To achieve the aims of REACH, companies manufacturing or importing chemical substances (that is individual single component chemicals) in quantities greater than 1 tonne per year, will be required to gather information on the properties, uses, and classification of those substances. This information will then form part of the registration dossier, which must include information on safe usage. For substances produced or imported in quantities greater than 10 tonne per year, a chemical safety report will also be required. For quantities above 100 tonne per year further information will be required.
What chemicals will be covered by REACH?
Products such as medicines, biocides, radioactive materials and wastes will not be covered by REACH; these are covered by other legislation. It is important to recognize that REACH requires registration of substances; that is individual single component chemicals. Preparations, Mixtures, and Formulations are not required to be registered under REACH, only each of their component substances.
How will REACH work?
For REACH to work, manufacturers of chemical substances will need to know how their products are used. Without this information it will be impossible to provide the correct and appropriate safety information. This means that in the early stages of registration and dossier generation, downstream users will be required to provide information on how substances are used. A downstream user is someone who uses chemicals in their own production processes. This could include food additives, water treatment chemicals, paints and hygiene chemicals.
How will REACH affect Holchem Customers?
Most large suppliers of formulated chemicals (for example; hygiene products, food processing aids, effluent treatments, corrosion inhibitors, etc) will be well aware of REACH and how it affects products supplied to their customers. However, it is advisable for users of chemical based products to produce an inventory of all chemicals used on site and contact the suppliers to confirm their position.
Competent Authority
A European Chemicals Agency has been formed to act as the central point of reference and will be responsible for managing REACH and providing a database from which consumers and professionals can find hazard information.
In the UK the competent authority is the HSE.
What are the time scales for REACH?
The EU regulatory framework for REACH was introduced on 29 October 2003.
First Reading: European Parliament Reading – 2005.
Second Reading: European Parliament Reading – 2006.
Regulation in force mid 2007.
July to November 2008 Pre-registration of substances.
2008 – 2010 Registration of substances produced or imported >1000 tonne.
2010 – 2013 Registration of substances produced or imported in the range 100 – 1000 tonne.
2018 – Registration of substances in the range 1- 100 tonne.
Statement of Holchem’s compliance
Holchem mainly produces formulated products by blending substances. Formulated products do not need to be registered. All of Holchem’s suppliers have confirmed that they are pre-registering the substances used in our formulations. However, over the last 18 months, the combination of BPD and REACH has resulted in a few raw materials being withdrawn by suppliers. We were given plenty of warning and were able to formulate around the problem. We suspect that a few more materials will disappear over the next few years, but this is unlikely to be an overnight occurrence, and again we will be able to formulate around the problem.
Overall, we do not anticipate REACH resulting in the withdrawal of any Holchem products.
Over the next few years Holchem will be asked by suppliers for information as to how substances are used, this will feed into the evaluation and eventual authorisation parts of REACH.
Although Holchem mainly produces formulated products, we do manufacture a few substances. These we have pre-registered. As the REACH process continues, we will support these substances to full registration.
Biocidal Product Directive (BPD)
The key aims of the BPD are to establish a single European market in biocidal products while ensuring a high level of protection for people and the environment. Consequently the aim of BPD is to ensure that biocidal products pose no unacceptable risks to humans, animals or the environment.
Biocidal Product Directive (BPD) applies to any biocidal product, not just those used in the food industry. An early example of the influence of BPD is that it is no longer possible to buy creosote for treating garden fences.
This enables manufacturers, suppliers or formulators, to market active substances and biocidal products throughout the European Union in the knowledge that, ultimately, the controls in place are the same in every Member State.
BPD achieves its aims using a two-stage regime of rigorous evaluation of biocidal active substances and then formulated products.
For active substances; manufacturers are required to submit an evaluation dossier that gives evidence to show:
- The active substance does not pose unacceptable risks to humans or animals.
- The active substance does not pose unacceptable risks to the environment.
- The active substance is effective as a biocide.
The cost of producing these dossiers is very high, as a result some active substances became commercially non viable and hence have been withdrawn.
When the dossier has been accepted across all EU member states, the active substance is formally listed on Annex 1, 1A or 1B of the BPD and can subsequently be considered for use in a biocidal product.
For biocidal products; manufactures are required to submit simpler dossiers, but can use data available from the actives dossier. However the considerations of harm to animals, humans and the environment are very specifically directed to the use application. Dossiers are in theory required in every member state in which a product will be sold, but there are arrangements for mutual recognition.
Legislation
The Biocidal Products Directive 98/8/EC (BPD) and the Biocidal Product Regulations (BPR).
Competent Authority
In the UK the competent authority is the HSE.