RESEARCH AND PRODUCT DEVELOPMENT;IMPACT ON BUSINESS

INTRODUCTION

Getting new products into the market in a cost-efficient manner is important for the fertilizer industry. Addressing Product Stewardship, to ensure that the fertilizer product meets the expectations of product quality and nutrient efficiency, can be handled and used safely without harm to people, property and the environment, and is as important as looking after the economic, technical and commercial aspects of product management.

In this guidance, product development includes both the creation of new products and the improvement of existing products.

LEGAL REQUIREMENTS

The responsibilities of management and the workforce in ensuring that all workplace activities - implicitly including those associated with product development - are carried out safely, are defined in national health and safety regulations. If product development involves supplying samples to third parties, then a number of further requirements may apply. These relate to the provision of Safety Data Sheets, to packaging and storage, and to distribution.
Commercial exploitation of new products may not be possible until compliance with a number of legal controls has been achieved. In some cases, legal requirements apply to changes in existing products.

FERTILIZERS 

 

PRODUCT ASSESSEMENT

In a simplified manner, product development takes place in three phases:

• Phase I - Ideas generation (normally at creation stage)
• Phase II - Feasibility assessment
• Phase III - Commercialisation and/or product change

For each phase a simple matrix of information should be established. Each item of information should be assessed, and its effect on the overall risk - and its manageability - of the product identified.

Confirmation that the product is acceptable should be made before moving forward to manufacturing, marketing and sales. Reference is made to the example checklist below.

	Specification	Market	Use
Phase I - Ideas generation (normally at creation stage)
Identity	New ingredients or components	Potential regions	Broad nature of potential use
	Any new chemistry of raw materials, additives, coatings, and in the processing of the materials
Consider (technically driven)	Inherent SHE issues in process	Marketing issues	Product HSE concerns (current/potential)
Phase II - Feasibility assessment
Define	Composition	Countries for which approvals are required	Prime and possible applications
Develop (driven by product steward or technical)	Technical and physical properties Any new data required due to: - new substances (from inventory check) - composition changes (from classification changes/SDS) - new ingredients Core Safety Data Sheet Containment/packaging options Process SHE issues	Understanding of national inventory/classification/application regulations for ingredients/product National transport and storage regulations All regulatory approvals necessary for release of the product on the market Ability to provide relevant language SDS Any new data required for national inventory check	Understanding of customer issues in use and potential for misuse and abuse Risk assessment in use Understanding of waste concerns and waste minimization Handling and use information
Phase III - Commercialization (and/or product change)
Define	Product name and specification	Countries for sale and those for which approvals needed	Intended applications and any exclusions
Complete and integrate into business	All actions in Phase II (reviewing assumptions) Establish Safety Data Sheet All actions within Implement through all stages of the product cycle Actions required for the Product dossier for documenting the findings of the product development and for submitting documents for regulatory approval Assessment of Impact on business

 

PRODUCT DOSSIER

It is recommended that the Members of Fertilizers Europe establish a product dossier for all fertilizer products. A product dossier brings together in one place all the information that the company holds on a product or on generic products. It facilitates maintaining and updating the information in a quality fashion. The dossier forms a useful checklist, ensuring that all aspects of the lifecycle have been adequately considered.

The typical information to be collected in a product dossier is shown in the form of headings below. Information will be held in different parts of the organization and if it is not physically to be treated in the dossier, then clear signposts needs to be in place to show how it can be retrieved and examined.

The dossier is not only important to the SHE function. Business and sales staff need to be familiar with its contents in order that they can market and supply the company's products effectively and in a responsible way.

A product dossier can be organized as follows:

Classification, labelling and basic data

This section sets out the basic information, including backing papers, for the formal hazard assessment of the product, including its hazard classification and required labelling for supply and/or transport if appropriate (see also). A record is also kept of the calculations used in the hazard assessment.

The UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Third Revised Edition 2009. ISBN 13-978-92-1-117006-1 Available from the Fertilizers Europe secretariat includes harmonized criteria for classifying substances and mixtures according to their health, environmental and physical hazards and harmonized hazard communication elements, including requirements for labelling and safety data sheets.

This section also provides the test results from detonation tests, decomposition tests, oxidation tests, etc. See for example UN Recommendations on the Transport of Dangerous Goods: Manual of Tests and Criteria. Fourth revised edition, 2003. ISBN 92-1-139087-7. Available from the Fertilizers Europe secretariat

Safety Data Sheets

Under this heading are copies of the present and past Data Sheets for the product. Additionally, if anything in a Data Sheet is based on non-obvious information, the source of the information should be recorded (see also).

Specifications and detailed analysis

Manufacturing specifications and product specifications for marketing and sales are listed in this section, together with all known impurities.

Uses/applications

Under this heading are recorded all intended uses and applications for the product. Any particular constraints or controls on these uses, the procedures/measures to be taken to conform to them, and the need for customer training, for example, are identified (see also)

Agronomic data and environmental fate

The agronomic benefits of the product should be documented, based on R&D tests, field trials and farmer applications.

Also, the environmental impacts of heavy metal impurities should be identified along with potential environmental impacts of unbalanced use of fertilizers (too much or too little). See also

Packaging

A record of the packaging options available, and what is used at present and why is given under this heading. Any circumstances for which the current packaging is not suitable should be stated. Routines for recycling of packaging materials should be identified. See also

Safety and security precautions

Specific safety and /or security restrictions on the manufacturing, handling and use of the product should be given, together with any measures that can be taken to prevent incidents.

Information to distributors, logistics operators and farmers

Specific information to the distributor, logistics operator and to farmers should be provided, e.g. information leaflets and training material (see also).

Market

Depending on the nature of the company's operations, it may be helpful to describe the product markets under this heading, identifying country, distributors, agents, customers, tonnages etc. This information will help in deciding what is appropriate in the rest of the dossier, and it will also enable the product to be marketed in a responsible fashion.

Relevant regulations

This section outlines any special regulations relating to the manufacture, distribution, supply or use of the product not covered above.

Improvement plans

Action plans to further reduce any risk associated with the product at any stage in its life can be summarized in this section.

Review process

This section records any particular measures needed to keep the dossier contents up-to-date, together with a target date for a review of the information and assessments which it contains.

In addition, in order to have a new fertilizer permitted to be designated EC Fertilizer according to Directive 2003/2003/EC, the registration of this product should be proposed to the EU Commission. Article 32.2 of that Directive makes references to Council Decision 1999/469/ECof 28 June laying down the procedures for the exercise of implementing powers conferred on the Commission (articles 5 and 7) OJ L184 17-7-1999 p23. A technical file according to the guidance given in Guide to the compilation of a technical file on applications to designate fertilizers EEC fertilizers pursuant to Directive 76/116/EEC. 94/C 138/04 of 20-05-1994 should be submitted. Many of the above mentioned sections are part of this guidance.

The EC2003/2003 fertilizers law is currently under revision.

IMPACT ON BUSINESS

An important part of the Phase III of the product assessment is to evaluate the SHE impacts on the business. A structured impact assessment provides a way of prioritizing potential adverse effects for management attention, and for highlighting SHE opportunities.

The impact assessment uses the outputs of existing assessments and also identifies where further detailed and technical risk assessment might be warranted. It is not a technical risk assessment in itself. Its output is primarily a prioritized risk and opportunity list which can be addressed by the business plan.

Companies should rate the potential damage to their business arising from possible adverse SHE events caused by, or involving, their products. They should also identify potential commercial opportunities which could arise from foreseeable SHE scenarios relevant to their products. Events may occur at any stage in the product lifecycle, and may be short or long term. By taking account of the probability of such events occurring, suitable action plans should be produced that manage and mitigate any risk and that take advantage of any opportunity.

The impact assessment should combine the conclusions of technical risk assessments with the risk perception and value-judgments of users, customers and society, in order to assess the overall implications for the business.

The impact assessment may be carried out as an internal business process, involving personnel whose responsibilities and expertise are relevant. It is best suited as a team activity. The following steps can serve as guidance:

Step 1. Describe the product range

Identify the product under consideration:

• specification - chemical, physical and packaging
• market - region or countries, industry or public
• use - broad area of use or application

Similarly, identify competing products in the market (own produced, third party products, and competitors' products). Identify the importance to the business of each product by considering volume and profit contribution.

Step 2. Identify threats and opportunities within the product lifecycle

Understand what happens at each stage of the product lifecycle including both within the organization and downstream at contractors and customers. Consider, for example, how the product is stored, handled and used, including the number of people involved and their competence. Identify any occurrence with significant potential for causing damage, harm or benefit, taking into account the product description in Step 1.

Address the business impact of risks to people, property and the environment - taking into account any technical risk assessments that have been completed. Address business risks - taking into account commercial, financial and perceived risks. Carry out a comparison with the impact of competitors' products and operations, and also consider the expectations of customers and society.

Identify any positive SHE attributes of your products by comparing the various analyses.

Step 3. Evaluate circumstances and consequences of risk

Rate each occurrence identified in Step 2 according to the magnitude of its impact.

Disastrous	Loss of business; loss of major part for several years
Damaging	Major business image concern; significant sales loss; authority prosecution
Costly	Significant business cost; threat to business growth; loss of customer, poor image
Minor	Modest business cost; operational concern; action that is not good practice
Beneficial	Enhanced business direction; improved business image

Step 4. Establish potential causes and consider likelihood of event

Decide how likely it is that each event which could lead to harm or opportunity will arise. Also, consider how likely it is that, should the event happen, harm or opportunity will actually occur. It may be difficult to quantify these probabilities - evaluating them as high, medium or low may be sufficient.

Step 5. Agree suitable action plans

By subjectively combining the severity of different events established in Step 3 with their probability, as determined in Step 4, a priority list of events - good and bad - which should be managed can be produced. The team should address the higher priorities and develop action plans for these.

Step 6. Review

The assessment will need to be reviewed:

• following any change to the product identity - specification, market or use
• following any change to the activities of the business
• periodically (to ensure change has been recognized)

Additionally, a periodic review of progress in carrying out the action plans is essential to maintain momentum.